Moreover, TG demonstrated a reduction in CoP velocity . These gait modifications were associated with decreased muscle activity during the different gait phases (p < 0.05). The PSM program effectively improved gait and neuromuscular capacities in older adults with SO. Notably, these results shed light on the remarkable trainability of neuromuscular capacities in older adults with SO, despite the adverse effects of aging and obesity.The potential impact of a specific physical activity program on biomechanical gait parameters and neuromuscular strategies around the ankle joint in older adults with sarcopenic obesity (SO) remains largely unexplored. The objective of this study was to investigate the effectiveness of a 24-week posture, strengthening, and motricity (PSM) program on improving neuromuscular strategies and biomechanical gait parameters in older adults with SO. 40 participants were randomly assigned to either the trained group (TG) and the control group (CG). Only the TG received the PSM program. Standardized evaluations were performed before and after the intervention, including walking tests on an instrumented gait analysis treadmill to evaluate biomechanical gait parameters and EMG activity of ankle muscles. After the PSM program, TG exhibited an increase in comfortable walking speed (+80%,  The rising prevalence of obesity in older adults is a global concern, as it is accompanied by a natural increase in fat mass and decrease in muscle mass and strength, resulting in sarcopenic obesity (SO) ,2,3. TheAging is associated with a decline in a variety of neural, hormonal, and environmental trophic signals to muscle ,12,13,14Research has demonstrated that obese individuals may experience difficulties in performing simple motor tasks with sufficient velocity, and they often exhibit greater instability during walking ,26. In aIn addition to the above studies, there is growing evidence for the synergistic impact of sarcopenia and obesity on gait and mobility in older adults ,34,35,36Many studies have indicated that physical activity is one of the most effective non-pharmacological interventions for the management of older adults with SO ,42,43. VThe main objectives of this study were twofold. Firstly, we aimed to assess the effectiveness of the PSM program on improving body composition and physical performance among older adults with SO. Secondly, we sought to investigate the effects of the PSM program on neuromuscular strategies during walking, ankle muscle strength, and gait parameters. We hypothesize that the PSM program changes body composition and improves physical performance in older adults with SO. Furthermore, we anticipate that the PSM program bolsters ankle muscle strength, modifies neuromuscular strategies during walking, and optimizes both kinematic and kinetic gait parameters in older adults with SO.Our study, a single-blinded multicenter randomized controlled trial, strategically placed participants into either a trained group (TG) or a control group (CG), as shown in Our study was carried out in compliance with the Helsinki Declaration. A local ethics committee approved the study protocol, patient information letter, and informed consent form. Our research was registered in the Pan African Clinical Trials Registry under the registration number PACTR202306912191110. This study and intervention are reported using the Consolidated Standards of Reporting Trials (CONSORT) and Template for Intervention Description and Replication guidelines (TIDieR) ,50.2, a Handgrip force (HF) < 17 N, gait speed < 1.0 m/s, being over 65 years old, having the ability to verbally communicate with the experimenters, and being physically independent. Exclusion criteria included the presence of neurological or cognitive impairments, severe cardiovascular problems, severe musculoskeletal deformities or injuries of the lower limb, co-morbidities, or chronic diseases, medication use that could interfere with testing, and a Montreal Cognitive Assessment (MoCA) test score of <26. These criteria were verified through a comprehensive survey questionnaire and reviewed by the medical staff at the respective facilities. Participants’ physical activity levels and cognitive scores were assessed using the Ricci and Gagnon [Participants were recruited from various obesity care centers located across the Tunis region, employing a recruitment strategy that combined direct clinic recruitment and leaflet distribution from 1st February to 31st October 2022. Participants had to meet specific criteria: having a BMI > 30 kg/md Gagnon  and the d Gagnon . WrittenThe sample size was calculated using the freeware G*Power (version 3.1.9.4) . The ANOThe randomization list was generated by a computer algorithm by an independent statistician from our partnering institution, ensuring that the study team remained impartial. The unique randomization number for each participant was obtained by the evaluating investigator (who was blinded to the treatment assignment) at the end of the screening process. This number was then electronically sent to the coordinating investigator at each center, who was unblinded to the assignments. Participants were randomized into one of two groups: the CG who continued with their usual activities and the TG who undertook the 24-week PSM program. To account for possible center effects, randomization was stratified by center, ensuring a balanced representation of participants from each center in both the CG and TG.Name: The PSM programWhy: The PSM program aimed to enhance physical performance, walking capacity in older adults with SO.What : The PSM program employed various physical materials to aid in the performance of the exercises; chairs for exercises such as sit-to-stands, balls for coordination and balance training, a stopwatch for timing exercises, markers, slats, and cups for creating obstacles or guiding movement paths, hoops, elastic bands, and weighted bags to increase resistance and challenge in the exercises.What (Procedures): The PSM program spanned 24 weeks, including two 60-min sessions per week, for a total of 48 sessions. Each session includes a warm-up (10 min), motor skill exercises (duration based on the pre-set training volume), strengthening/posture exercises (duration based on the pre-set training volume), and a cool-down phase (5 min). Motor Skill exercises form an interactive segment involving dynamic movements such as interactive walking, where participants maintain eye contact as they walk towards each other or retreat to their original positions. These exercises also include various obstacle courses that require participants to navigate through specified areas, stepping over objects like cups or hoops without making contact. Additionally, participants engage in weight-fetching drills, which require rising from a seated position, navigating obstacles, retrieving weighted bags, and returning to the start point. To add a layer of complexity and competitive spirit, these exercises are varied by increasing the number of objects, timing tasks, or introducing competitive elements among groups. Simultaneously, strength training exercises focus on enhancing various muscle groups. Participants execute a wide array of movements, including ankle dorsiflexion, plantar flexion, and exercises that emphasize upper body and postural muscles such as arm flexion/extension and lumbar muscle strengthening. Resistance training is also integrated using weights and balls, adding an additional challenge to the exercises. Progressive challenges are introduced by adjusting the speed of execution, altering arm positions, and incrementally adding weights to amplify the difficulty level. The program also incorporates posture exercises designed to enhance the proprioceptive system and improve balance. Participants engage in exercises such as balancing on unstable surfaces and resisting mild pressure exerted on various body parts by a partner. They also perform exercises like traversing obstacles with added weights, stimulating their balance and postural control. Multi-directional pressure resistance exercises further enhance balance, sometimes incorporating unexpected pushes to present an added layer of challenge.Who: By a kinesiologist specialized in adapted physical activity.How: In collective, face-to-face sessions.Where: In the fitness hall of each respective structure.When and how much: The PSM program begins on the 21st of March and concludes on the 21st of September 2022, spanning a total of 24 weeks. Each week includes two sessions, making a cumulative total of 48 sessions. Each session is 60 min long. The design of all exercise types within the program was based on each session’s specific training load (see item 9) and on pre-set training intensity and volume for each session (see item 11). The regimen for each exercise type involved anywhere between 1 to 5 sets, with the repetitions for each set ranging from a minimum of 3 to a maximum of 15.Tailoring: The variation in training load was determined after each session, based on the rating of perceived exertion scale (RPE) [le (RPE) . The RPEModifications: Adjustments were made to the exercises in each session, with an increase in the number of series or repetitions based on the training load. The difficulty was also progressively enhanced by adding obstacles, setting a time limit for task completion, and other means to ensure gradual progression and increasing solicitation.How well (planned): The program’s progressiveness was based on two aspects: a quantitative aspect related to the training load (volume/intensity) and a qualitative aspect related to the type of exercises . According to the quantitative aspect, the PSM program was structured into 3 micro-cycles of 16 sessions each: the first micro-cycle focused on volume, the second on intensity, and the third micro-cycle aimed to balance both volume and intensity : the TG attended all sessions.The PSM program is described based on a study conducted by Maktouf et al.  and adheThe evaluations described below were conducted in an identical manner and at the same time of day by the same evaluating investigator before and after the PSM program.Anthropometric measurements were taken, including height, waist circumference (measured at the midpoint between the 12th rib and the iliac crest), and hip circumference (measured at the widest part of the hip) using a tape measure. Body weight (BW) and fat body mass  were measured using an impedance-meter . FBM and lean body mass (LBM) were calculated using the equations from :FBM = boThen, participants were instructed to complete two walking trials in a 20-m corridor to determine their preferred and maximal gait speed (m/s). To eliminate the acceleration and deceleration phases from the analysis, only the speed between the 5th and 15th meters was measured. Finally, the senior fitness test was performed as assessment tools to measure the physical performance of participants and detect any functional limitations .Isometric contractions of the ankle plantar flexors (PFs) and dorsal flexors (DFs) muscles of the dominant leg, maximal voluntary contractions (MVC) were recorded using a dynamometer . Participants were instructed to keep their back, buttock, and thigh in contact with the chair and their leg stretched horizontally while pushing with the tips of the foot on the dynamometer for PFs. For DFs, participants were asked to stand up, keep their ankle at 90° and push with the foot on the dynamometer . To ensuParticipants were familiarized with walking on an instrumented gait analysis treadmill  for 5 min at their pre-calculated preferred walking speed previously measured, followed by a 2-min seated rest period. If participants experienced any difficulty in walking on the treadmill, they were given an additional 2 min of training. Subsequently, participants performed three 1-min trials, with each trial separated by a 5-min seated rest period. Data were collected for a period of 10 s, starting at the 10th second of each trial. The treadmill software 1.12  sampled the gait parameters at 100 Hz from the treadmill force plates. These parameters included spatiotemporal parameters, walking cycle phases, GRFv, CoP displacements. Spatiotemporal parameters such as step length, step width, and stride length were recorded. The software divided the walking cycle into support phase (SU) and swing phase (SW), consisting of the first double support (1st DS), a single support (SS), and the second double support (2nd DS). The absolute GRFv peaks were used to calculate the relative GRFv peaks  by dividing the absolute value of the GRFv peak by the body mass. The CoP data were used to extract the CoP length during the SU and SS, the CoP anteroposterior position, and the CoP velocity during walking (cm/s).® Wireless Biofeedback System . The EMG recording was synchronized with the treadmill data using a control device operating on the principle of a synchronization switch system (ON/OFF). The sensors composed of two pairs of silver bar contacts with 10 mm interelectrode spacing electrodes were placed on the gastrocnemius medialis (GM), soleus (SOL), and tibialis anterior (TA) of the dominant leg, conforming to the recommendations of SENIAM. The raw EMG signals were post-processed using Matlab software . The data from 10 strides were collected for a period of 10 s, in the 10th second of each trial , and were band-pass filtered at 15–500 Hz through a second-order Butterworth digital filter to remove noise or movement interference [Electromyographic (EMG) data from ankle joint muscles were collected during MVC of PFs and DFs, and during a treadmill walking test using Trignorference . The datrference  and calcrference : (1)RMS For the MVC tests, a moving window with a width of 20 ms was used to find the maximum RMS EMG activity resulting from the three efforts of MVC for each kind of contraction. Then, all RMS EMG data of walking on the treadmill test were normalized using the following equation for each muscle:The normalized RMS of the GM (RMS GM), SOL (RMS SOL), and TA (EMG TA) of each walking cycle’s phase were used in the study.p < 0.05 for all results.The statistical analyses were conducted using Statistica Software 13.0 . The normality of the data distribution was checked using Kolmogorov–Smirnov tests. When the data distribution followed a normal distribution, paired t-tests were applied to compare the results of the same group before and after the PSM program. The independent samples t-test was also used to compare between the TG and CG before and after the PSM program. The relationships between the changes in gait parameters and the relative maximal force of the DFs and PFs, anthropometric parameters, and muscle activity of GM, SOL, and TA were evaluated using the Pearson’s correlation analysis. The data were expressed as means and standard deviations. The significance threshold was set at n = 20; age = 76.6 ± 5.6 years; BMI = 35.8 ± 2.7 kg/m2) and the TG .In our study, we initially enlisted the participation of 72 volunteers through a recruitment strategy involving direct clinic recruitment and leaflet distribution in related centers. However, only 52 participants met our established eligibility criteria. Despite their initial inclusion, 12 individuals did not fully complete the study due to non-adherence to the protocol—7 from the CG and 5 from the TG. Several varied factors contributed to participant dropout, including the unfortunate passing of 2 participants, relocation to other centers for 3 individuals, health-related hospitalizations such as stroke, hip fracture, and ankle sprain for 4 participants, and personal reasons leading 3 participants to discontinue their involvement. A cohort of 40 participants who successfully completed the study in its entirety were randomly divided into two groups : the CG p < 0.05) and a decrease in FBM  (p < 0.01), sit-to-stand test , walking back and forth , 2-min walk , and 2-min knee lifts   and dorsiflexor  muscles  . GT demo< 0.001) . The PSM muscles .p < 0.001) and step length . The duration of the left and right stance phases decreased , while the durations of the left and right swing phases increased . Additionally, the durations of the initial left and right double stance phases  and the left and right pre-swing phases  decreased. Moreover, TG demonstrated a reduction in CoP velocity . Notably, TG also displayed increased GRFv in the left  and right  P1 forces, as well as the left  and right  P2 forces.Spatiotemporal parameters, gait cycle parameters, center of pressure displacement parameters, and vertical ground reaction forces are presented in p < 0.01). Additionally, TA activity decreased during the first double support phase  and single support phase , while muscle activity in SOL decreased during the first stance phase  and second double support phase   .p < 0.05) as well as DF . Furthermore, a positive correlation was observed between the decrease in CoP velocity and the reduction in RMS SOL  and RMS TA . Additionally, a positive correlation was identified between the increase in relative P1 and the absolute DF force . A positive correlation was also found between relative P2 and the increase in the absolute DF force .The person correlation analysis revealed significant correlations between the changes in gait parameters and the evolution of neuromuscular parameters following the PSM program . NotablyThe objective of this study was to evaluate the impact of a physical activity program based on muscle strengthening, balance, and motor exercises on body composition, physical performance, neuromuscular capacities, and biomechanical gait parameters in older adults with SO. The results indicate that the PSM program improved walking ability and functional capacities in this population. These improvements were associated with an improvement in neuromuscular capacities. Our study contributes to the existing body of literature ,46,47 byOur study demonstrated significant improvements in various measures of physical performance following the implementation of the PSM program . NotablyTo our knowledge, this study is the first to evaluate the effects of a physical activity program on neuromuscular capacities and their contribution to the improvement of walking abilities in older adults with SO. The results of this study showed that walking parameters, including preferred gait speed (+66%), maximal gait speed (+71%), and step length (+38%) in SO older adults were significantly improved after the PSM program and were associated with a reduction in the duration of the stance phase (−5%) and an increase in the duration of the swing phase (+4.9%). These improvements can be attributed to two possible mechanisms. First, the improvements in gait parameters could be attributed to a reduction in postural instability during walking. Maktouf et al.  demonstrSecondly, the improvements in gait parameters observed in our study may be attributed to the enhanced neuromuscular capacities of the ankle muscles. Results showed a positive correlation between the increase of the absolute PF and DF forces and the relative P2 (r = 0.76) and P1 (r = 0.74) in the TG. The increase in GRFv during walking indicates improved force generation during the amortization (P1) and propulsion (P2) phases of walking. Notably, this increase in force generation was accompanied by a decrease in muscle activity of the GM (−23.9%) and SOL (−17.5%) during the first stance phase and propulsive phase, respectively. These findings suggest that the augmented maximal force production capacity of the plantar flexor muscles, achieved through muscle strengthening exercises, partially contributed to the enhancement of gait quality in older adults with SO. Specifically, obese older adults face difficulties in generating adequate force relative to their body mass during forward propulsion . ConsequFurthermore, it is crucial to recognize that the observed improvement in force production capacity, specifically the increased muscle strength of the ankle muscles, did not demonstrate a direct correlation with the enhancement of gait parameters, such as maximal speed and step length. This finding highlights the multifaceted nature of walking and suggests that solely focusing on developing greater muscle strength or improving postural control stability may not be sufficient to enhance the overall quality of walking . WalkingBased on the findings of our study, the implementation of a physical activity program for frail populations, such as older adults with SO, should prioritize two key aspects. Firstly, it is crucial to tailor the quality of exercise to address the specific characteristics and impairments of each individual. This personalized approach is essential to directly target the identified alterations and promote effective interventions. Secondly, the quantitative aspect of the program should be based on patients’ perceived exertion, allowing for the prescription of an optimal exercise intensity for each individual. This approach ensures that patients do not work under fatigued conditions, which may yield negative outcomes. Moreover, it enables the provision of an appropriate intensity that adequately challenges the targeted systems, preventing the use of inefficient dosages that fail to elicit the necessary stimulation for adaptation. Furthermore, regular assessments throughout the program are essential to monitor progress and make necessary adjustments to the training load or exercise type, facilitating ongoing adaptation and optimal outcomes. Finally, it is vital to consider psychological and social factors, such as motivation, to ensure the continuity of physical activity practice among older adults. By creating a supportive and engaging environment, the program can foster sustained motivation, thereby promoting adherence and the continued benefits of physical activity for older adults with SO.This study presents a pioneering investigation into the effects of a physical activity program focused on muscle strengthening, posture, and motor exercises on gait parameters and neuromuscular strategies during walking in older adults with SO. This innovative approach provides valuable insights into the underlying mechanisms that contribute to the observed improvements in this population. However, there are several limitations to consider. Firstly, the small sample size may limit the generalizability of our findings. Future studies with larger sample sizes are needed for validation and increased statistical power. Furthermore, our study concentrated mainly on the muscles surrounding the ankle joint. Given the potential for excess adipose tissue in the areas of the knee and hip joints to influence EMG signals, it would be advantageous to incorporate a 3D gait analysis. This would involve assessing joint moments and ranges of motion across all three joints—hip, knee, and ankle. Moreover, dietary intake was not monitored, but future studies could explore the synergistic effects of physical activity and protein intake. Finally, comorbidities and specific medical conditions may have influenced outcomes, suggesting the need for adjustment in future studies.This study demonstrated that a physical activity program incorporating muscle strengthening, balance, and motor exercises had a positive impact on older adults with SO. The program effectively improved body composition, physical performance, gait, and neuromuscular capacities in this population. The improvement in walking ability can be attributed to the reduction of age- and obesity-related impairments. Despite the acute effects of aging and obesity, this study confirmed the trainability of neuromuscular capacities in older adults with SO, highlighting the potential for reversibility and improvement. Considering the reversibility of neuromuscular impairments, it is crucial to promote early intervention and sustained engagement in physical activity to maximize the potential for long-term improvements in mobility and independence. By integrating these findings into clinical practice and public health strategies, we can work towards optimizing the health and well-being of older adults with SO.


Surgical voluntary medical male circumcision (VMMC) is a safe procedure; however, maintaining quality standards at scale, particularly during scale-up, is a challenge making ongoing quality management (QM) efforts essential. This study describes program quality measured by rates of adverse events (AEs) over four years of VMMC implementation in Namibia, compares AE rates over time, and discusses QM processes that contextualize AE trends and illustrate improvements in quality as the program matured. The International Training and Education Center for Health (I-TECH) assisted the Namibian Ministry of Health and Social Services (MoHSS) in expanding VMMC in three regions among boys and men over 10 years of age between January 2015 and September 2019.A comprehensive package of QM strategies was implemented by multi-disciplinary onsite teams with support from national and international technical advisors. Retrospective routine MoHSS data from the VMMC register, client forms, and monthly AE reports were collected during implementation in the three regions to assess the impact of QM interventions on AEs and to calculate the proportion of clients who experienced AEs over time. The proportion of clients who experienced an AE over time was compared using a Cochran-Armitage test for trend.Between January 2015 and September 2019, 40,336 clients underwent VMMC and 593 (1.5%) clients experienced a post-operative AE in the three supported regions. The AE rate was highest in the first quarter of clinical service delivery in each region  but declined over the implementation period as the program matured. This observed trend between program maturity and declining AE rates over time was significant (p < 0.001) when compared using a Cochran-Armitage test for trend.As the I-TECH-supported VMMC program matured, QM measures were introduced and routinized, and clinical quality improved over time with the rate of AEs decreasing significantly over the implementation period. Applying systematic and continuous QM processes and approaches across the continuum of VMMC services and considering local context can contribute to increased clinical safety. QM measures that are established in more mature program sites can be quickly adopted to respond to quality issues in program expansion sites. Voluntary medical male circumcision (VMMC) programs have been rapidly scaled, particularly in Southern and Eastern Africa, to meet World Health Organization (WHO) and Joint United Nations Programme on HIV and AIDS (UNAIDS) goals of 5 million VMMCs performed annually and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) targets of 80% circumcision coverage of the eligible population , 2.When implemented in line with internationally established guidance, VMMC is a safe procedure . To mainQuality management (QM) comprises all activities designed to achieve and sustain high-quality outputs and encompasses quality assurance (QA), quality control (QC), and quality improvement (QI) approaches , 7. QA aThe WHO defined strategies for safeguarding VMMC quality, also incorporated into PEPFAR-funded program guidance, emphasize ensuring provider competence, monitoring and evaluating program outcomes including adverse events (AEs), and developing and implementing standard operating procedures and best practices for providing information and education to clients and communities , 11.Rates of AEs, especially during rapid program scale-up, are a key indicator of VMMC program quality given the critical importance of patient safety and good clinical outcomes in large scale VMMC efforts . AdverseThe objectives of this analysis are to (1) describe program quality measured by the rate of AEs that occurred over four years of program implementation in Namibia; (2) describe trends in AE rates over time; and (3) describe implemented QM processes to provide context to observed trends in AEs within Namibia and illustrate improvements in program quality as the VMMC program matured. This analysis builds on previously published work that provided a summary of the overall AE profile of Namibia’s VMMC program including AE type and timing, association of VMMC characteristics and AEs, as well as factors associated with AE severity .In 2010, the Namibian Ministry of Health and Social Services (MoHSS) launched its National Policy on Male Circumcision for HIV Prevention . To helpThe VMMC program was staffed by multi-disciplinary teams consisting of clinical, demand creation, and strategic information staff at the site level. The teams operated a main VMMC clinic integrated into the MoHSS hospital in each district, as well as regular outreach services at community-based primary healthcare (PHC) clinics and at other community institutions . All VMMC clinical staff completed theoretical and proficiency training including required completion of 20 VMMC procedures under direct supervision of an experienced and accredited supervisor prior to certification. The three regional site-teams were supported by a strategic leadership team based in Windhoek, Namibia, as well as Technical Advisor, Monitoring and Evaluation Advisor, and Senior Program Manager based in Seattle, USA. The Windhoek-based technical team provided close supervision and support to the site teams and undertook regular site visits that included onsite training, mentoring, and coaching on the implementation of QM measures. This multi-disciplinary team approach facilitated an environment in which service quality was prioritized, challenges were continuously identified, and contextually driven solutions were implemented.The program implemented a comprehensive package of QM measures described in Fig. Overall, the QM processes were implemented across three intervention levels: clinician facing interventions, client and community facing interventions, and interventions targeting program systems and processes. Clinician-facing activities safeguarded VMMC provider competency through training, development and implementation of job aides, and tools for continuous improvement of clinical service delivery. Client and community-facing activities focused on patient and caregiver education related to hygiene, pain management, and post-operative wound care, as well as provision of targeted wound care supplies and counseling. Systems-level QM measures focused on data review and management through implementation of new tools, new or modified clinical procedures, review of assessment and monitoring processes, and promotion of routine team-based data use to improve quality. This was supported by virtual weekly progress review and learning sessions which brought together site-level and above site-level team members.This study was conducted under a routine data use protocol approved by the U.S. Centers for Disease Control and Prevention (CDC) and the MoHSS. and received a non-research determination from the University of Washington institutional review board. In Namibia, adults < 18 years must obtain written approval from a parent or guardian for VMMC surgical procedures, no additional verbal or written consent from patients was not sought for this secondary analysis of the de-identified, aggregate data.For this analysis, we compiled routine monthly MoHSS AE reports (January 2015–September 2019) of individuals with moderate and severe AEs kept by clinicians at each site. MoHSS monthly program summary reports compiled from site-level VMMC registers and client forms by I-TECH’s site-level staff were used to establish the denominator of the number of VMMCs performed. The number of VMMCs performed served as the denominator in the calculation of AE rate as follow-up completion was nearly 100%. Both the AE line list data and the summary report data were analyzed at an aggregate level and disaggregated by location and program year.Internal program documents such as site visit reports, IQA and EQA reports, and emails and meeting notes were reviewed to identify QM activities implemented during the study period and to detail illustrative vignettes that demonstrate how quality issues were identified and resolved.The proportion of clients who experienced AEs were calculated using the compiled routine program data of the total clients who underwent VMMC during the implementation period as well as the total clients who experienced an AE (as identified by the line lists). The proportion of clients who experienced an AE over time was compared using a Cochran-Armitage test for trend. Confidence intervals (CI) (95% percentile) for AE rates by site calculated using Wilson estimates for trend analysis. This analysis was conducted using STATA 16.Two surgical circumcision techniques were used during the study period. Forceps-guided and dorsal slit VMMC were approved for clients ages 15 and older; for clients ages 10 through 14, only the dorsal slit VMMC procedure was approved. Clinicians determined the surgical type for clients aged 15 and above based on glans maturity. In Namibia, VMMC for clients aged 10–14 formed part of the 2010 Namibia National VMMC Policy and the dorsal slit procedure was authorized through an official policy circular issued by the MoHSS in October 2016.Generally, severe AEs require surgical intervention or hospitalization. Any AE not classified as severe but requiring medical intervention was considered moderate , 12. MilThe level of program maturity is represented by program duration.During the study period, 40,336 VMMCs were performed in three regions with 593 clients documented in the line lists as experiencing an AE Table . Over thThe AE rate was highest in the first quarter of clinical service delivery January-March 2015 in Oshana and Zambezi at 4.29 and 4.02 per 100 circumcisions performed and during the inception quarter of October-December 2017 in //Kharas at 11.49 per 100 circumcisions performed but subsequently consistently declined with increasing program maturation  action plans were applied to guide focused coaching, application of guidelines, and on-site training to improve routine VMMC program quality across the spectrum of VMMC program delivery finding that average program quality increased significantly  across CQI categories with larger gains in management and M&E over those observed in VMMC counselling or surgical skills . A previThere were several key concrete QM steps implemented as part of our program that VMMC or service delivery teams elsewhere may be able to implement. Starting in Oshana and Zambezi, and later in //Kharas, a multi-disciplinary team reviewed and discussed program data and AE rates on a weekly basis. Above-site technical advisors also made frequent in-person support visits to provide supportive supervision and mentorship and coaching. During those data reviews and site visits, conversations were held with the clinicians and clients and operations were observed to identify variations in quality standards. These reviews led to data-driven identification of problems, promoted joint team generation of possible solutions, and suggested specific new interventions for testing in support of continuous quality improvement.This study and findings are subject to several limitations. First, although implemented in three regions, overall absolute eligible target population numbers for VMMC are small, allowing for integration of intensive QM efforts using dedicated staffing and resources. The program had adequate technical assistance to step back from implementation and review data, identify solutions, and test change. This level of QM effort and resource application would likely not be sustainable on a national scale in less highly resourced regions. Second, these QM efforts were successful for the VMMC program but had limited direct benefit to the larger health systems in which the VMMC program was implemented. Future efforts should ensure that QM gains in a specific program will support horizontal approaches that strengthen other priority programs and the larger health system through capacity building, empowering local ownership, and developing cross-cutting quality management infrastructure . Third, Findings from this study lead to several programmatic recommendations that may further improve clinical service quality in Namibia’s VMMC program and are also applicable to other VMMC programs. Key findings and recommendations from this analysis include: (1) routinizing QM processes as the program matured aligned with an observed increase in clinical safety and improvement in program outcomes, (2) QM processes and approaches were applied across the continuum of VMMC services including client and community facing education and counselling, (3) QM efforts carefully considered and responded to the local context and were implemented using a multi-disciplinary team approach spanning multiple levels of the health system, (4) QM measures and experience established in more mature program sites can be applied to rapidly and efficiently resolve issues arising in program expansion sites with care taken to continue to be responsive to the specific sub-population and community needs in the expansion site. Patient safety and clinical outcomes are critical as VMMC programs continue to scale to meet ambitious national and international targets.


Delivery of proven structured lifestyle change education for reducing the burden of cardiometabolic diseases such as diabetes at worksites could overcome barriers to program adoption and improve sustainability and reach of these programs; however, tailoring to the worksite setting is essential.The Integrating Diabetes Prevention in Workplaces (INDIA-WORKS) study tested the implementation and effectiveness of a multi-level program for reducing cardiometabolic disease risk factors at eleven large and diverse worksites across India. Herein, we describe and classify program adaptations reported during in-depth interviews and focus group discussions with worksite managers, program staff, peer educators involved in program delivery, and program participants and drop-outs. We used thematic analysis to identify key themes in the data and classified reported program adaptations using the FRAME classification system.Adaptations were led by worksite managers, peer educators, and program staff members. They occurred both pre- and during program implementation and were both planned (proactive) and unplanned (proactive and reactive). The most frequently reported adaptations to the individual-level intervention were curriculum changes to tailor lessons to the local context, make the program more appealing to the workers at the site, or add exercise options. Other content adaptations included improvements to the screening protocol, intervention scheduling, and outreach plans to tailor participant recruitment and retention to the sites. Environment-level content adaptations included expanding or leveraging healthy food and exercise options at the worksites. Challenges to adaptation included scheduling and worksite-level challenges. Participants discussed the need to continue adapting the program in the future to continue making it relevant for worksite settings and engaging for employees.This study describes and classifies site-specific modifications to a structured lifestyle change education program with worksite-wide health improvements in India. This adds to the literature on implementation adaptation in general and worksite wellness in India, a country with a large and growing workforce with, or at risk of, serious cardiometabolic diseases. This information is key for program scale-up, dissemination, and implementation in other settings.Clinicaltrial.govNCT02813668, registered June 27, 2016 At least 74.2 million and 115.3 million people in India have diabetes or prediabetes, respectively, many of whom are working age adults , 14, 15 Delivering lifestyle interventions at worksites, using the existing structure of worksite health facilities for testing and training and utilizing employees as peer educators, could be an effective and cost-effective approach for delivering lifestyle change education. Furthermore, it may overcome many individual-level barriers to participation in a lifestyle change program  and could be beneficial to employers  , 25, 26.Clinicaltrial.gov, NCT02813668, registered on June 27, 2016, https://classic.clinicaltrials.gov/ct2/show/NCT02813668) implementation study, which aimed to overcome barriers to worksite delivery of lifestyle interventions by using the peer educator model while promoting worksite-based environmental changes to support program participants. We applied the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) classifi2 and/or waist circumference ≥ 90 cm for men and ≥ 80 cm for women (1c of 5.7–6.4%) or diabetes (HbA1c ≥ 6.5%); not currently taking any diabetes medications; not pregnant or breastfeeding; and without history of heart disease, current serious illness, or conditions impeding participation in an unsupervised physical activity and diet change program. Eligible individuals were identified using a two-phased screening program at each worksite. Multi-stage screening activities were conducted over multiple days at the worksite to minimize time away from work for employees and avoid unnecessary testing for ineligible individuals.The INDIA-WORKS intervention was based on the program tested in the D-CLIP trial , a transor women ; have prThe multi-level intervention package included both a structured lifestyle change program  and supportive changes to the worksite environment . The individual-level intervention was designed to benefit those employees enrolled in the lifestyle change program, while any changes to the work environment could benefit all employees. The intervention package included core components which remained standard across sites and adaptable elements which could be modified to suit individual worksite settings. Core components were:  key desiAdaptations to the INDIA-WORKS curriculum and delivery were identified and described through qualitative interviews  with differentpopulations involved in the delivery, management, and use of the INDIA-WORKS program. Qualitative data collection occurred during the first year of the study (December 2018-June 2019). We conducted in-depth interviews to understand individual level experiences of high-level worksite managers (n = 16), peer educators (n = 29), program drop-outs (n = 29), and INDIA-WORKS team members involved in on-site implementation of the program (n = 8). In addition, we conducted 14 FGDs with program participants who completed the program  to understand community-level experiences of the program. In-depth interviews and FGD guides explored views of the program, context-specific program adaptations made and their challenges, and suggestions for sustaining the program. Participants for the in-depth interviews and FGDs were recruited via a gatekeeper strategy, first by discussing the purpose and data collection procedures with managers and asking for their permission and support for the data collection. We included participants suggested by managers in our pool of potential participants, as well as individuals identified by local study staff in order to ensure a diverse and information-rich sample for the qualitative data. Potential interview/FGD participants were approached via email, phone call, and/or in- person contact.All interviews and FGDs were conducted privately by a trained member of the INDIA-WORKS study team at a private location at the participant’s worksite in their preferred language . Participants participated in only one FGD or interview. For manager interviews and INDIA-WORKS staff interviews, interviewers had been in contact with the interviewees; however, care was taken to ensure that interviews with staff were not done by that person’s supervisors. For all other interviews/FGDs, there was no prior relationship between the interviewer and interviewees. Participants provided written informed consent for the interview and audio-recording of the discussion; as part of the consent process the goals of the qualitative data collection and reasons for the research were described to participants. Interview team training included training on interviewing and FGD moderation techniques, reflexivity, and the data collection tools. The interview team met at least once per week to de-brief and data collection was continued until:  there waThe discussions were guided using semi-structured interview/FGD guides, which were informed by the D-CLIP study , ProctorTranslated, verbatim transcripts of the in-depth interviews and FGDs were managed using MAXQDA 2020 (VERBI Software). Using thematic analysis techniques, a codebook including both deductive and inductive codes for each set of qualitative data  was created. Three coders coded the data which involved assessing inter-coder agreement, rectifying discrepancies in coding, and then coding transcripts independently. Four codes, “Adaptations,” “IW Worksite Context,” “Sustainability,” and “Future Suggestions/Adaptations” described program adaptations, explored reasons changes were made, and detailed suggested adaptations for the future. These codes were the focus of this analysis.What was modifiedThe level of the modification - here, individual-level or environmental-levelThe nature, or type, of the modification - e.g., tailoring, refining, adding elementsThe goal of and reason for the modificationWhen the modification was made - pre-implementation or during implementationIf the modification was planned or unplanned and proactive or reactiveWho participated in the decision to make the modification - here, reported as the specific players, INDIA-WORKS staff, worksite managers, and peer educators, which are included in the following FRAME categories for this domain: INDIA-WORKS Staff includes treatment/intervention team, program developers and purveyors, and individual practitioners/facilitators; peer educators are individual practitioners/facilitators ; and Worksite Managers are administrationIf the modification was fidelity consistentCoded segments were reviewed and a thick description of each code was developed describing adaptations to the INDIA-WORKS curriculum, worksite environmental changes, changes to improve program acceptability, challenges to program adaptation, and suggestions for additional changes for the future. Modifications and adaptations were then categorized and described by applying the FRAME , a comprIn addition, we described challenges to adapting the program at the worksite and suggestions for future adaptations of the program. Results were shared and discussed with members of the study team involved in field work; due to challenges of the COVID-19 pandemic at the worksites, it was not feasible to review findings and interpretations with worksite interviewees.Participants described INDIA-WORKS curriculum adaptations, the creation of new or leveraging of existing health programing at the worksite level, and adaptations to improve recruitment or retention of participants in the intervention. Participants also discussed adaptation challenges and suggestions for future modifications. Program adaptations were made at worksites before and during the first year of project implementation. Worksite managers, peer educators, and INDIA-WORKS staff members all reported making program adaptations to ensure successful program delivery at individual worksites. Adaptation were fidelity-consistent, unless otherwise noted, reflecting modifications to adaptable, and not core, components of the intervention package. Herein, we report on cohort-level adaptations to the individual-level intervention content including adaptations to study curriculum or testing and those made at the environment-level and affecting all participants at that site. For each, we map the adaptations to FRAME components (Tables 2 and 3), providing illustrative examples in the text. In addition, we report on adaptations to training.Content adaptations affected the individual-level intervention and included changes to the program curriculum as well as tailoring program and testing logistics to make the program more understandable and approachable for program participants (Table 2).The most discussed adaptations were to the curriculum. Managers, peer educators, and INDIA-WORKS staff all discussed the importance of presenting the curriculum in a way that is understandable and relatable to the worksite employees. Adaptations included planned changes pre-intervention  and reactive adaptations implemented during the program to improve program acceptability and participant engagement . Peer educators and INDIA-WORKS staff tailored examples and dietary advice to local diets, focusing on eating smaller servings of foods that were familiar to participants to improve participant acceptability. A few peer educators also felt that local diets were the best suited for disease prevention and health. As one Peer Educator shared: “suppose I was born and brought up in a Chattisgarhi family and since my birth, whole time my 3 meals are only rice and rice and rice. This is never going to harm me … your body is adjusted to that type of diet.” A couple of peer educators made additional adaptations in the lifestyle classes they led based on personal views; for example, adding breathing exercises to reduce stress or moving the order of lessons to focus first on physical activity then on diet. This last example was not consistent with the class curriculum, reflecting a lack of fidelity to the program.Several sites expanded the exercise program during implementation to add more advanced options like more intensive aerobics, Zumba, or yoga classes. Zumba classes were particularly well received by INDIA-WORKS participants . Some worksites refined the physical activity curriculum to provide additional training on skills they felt the participants were lacking. This included helping participants to dress in proper exercise clothing and shoes for comfort and safety, focusing on proper breathing techniques when exercising, proper stretching to decrease pain and soreness, and being more active in their daily lives.To increase overall program acceptability, sites adapted the program to improve testing uptake, recruitment, and retention. INDIA-WORKS staff members reported applying lessons learned at initial screening and testing visits to testing at subsequent worksites ; for example, collecting blood samples and follow-up data at a single study visit instead of multiple visits, improved data completion. One worksite expanded study testing to better monitor program success by funding HbA1c and exercise testing for all participants.Worksites sought to improve enrollment and retention by making the classes to employees. Classes were held at times convenient for participants and permissible to supervisors. Classes at some sites were held during work hours, but most (“90 percent” INDIA-WORKS Staff) held classes after work hours. When this was challenging for participants, some worksites agreed to allow participants 30 minutes at the end of the workday for a classes. At sites with shift workers, class times changed as participants’ shifts changed. INDIA-WORKS staff worked with management to select the most convenient venue for classes to improve participation and noted that different locations yielded better, or worse, class attendance. Although class scheduling was a planned adaptation , worksites had to continue making reactive/unplanned changed to class times and locations to find the ideal class time for different workers at the site.Other sites sought to increase enrollment proactively by making the program more appealing to participants or widening eligibility criteria for some or all intervention components. One manager described how the program was presented as a way to reduce risk factors instead of labeling participants: “When you tell the participants…’you are a pre-diabetic, you are a hypertensive, you are a diabetic,’ they feel offended. They feel bad. They feel depressed. …we say, “You are a high-risk individual. There is goal for improvement.” (Worksite Manager). Another worksite hired retired local doctors to promote the program. Other sites allowed non-eligible workers to participate in some program components  but not study testing.During program implementation, worksites made reactive adaptations to improve participant retention. Across sites, peer educators and INDIA-WORKS staff, and at some worksites managers, reported calling or messaging (via text or WhatsApp) participants to remind them of class, schedule sessions or reschedule makeup sessions when conflicts arose. Makeup sessions, either newly scheduled sessions, one-on-one classes, or allowing participants to join another group for that week, were commonly employed to ensure that participants covered the course material even when their work schedules changed or required them to miss a class. For workers facing the most barriers , lessons were delivered individually at participants’ desks.Organization-level adaptations are shown in Table 3. While changes to the worksite canteens were all planned/proactive and pre-implementation, worksite-level changes to physical activity resources and health programming were both planned and unplanned and occurred both pre- and during implementation. Managers reported that making environmental changes at the worksite required them to consider both health recommendations and worker preferences to increase acceptability and avoid push-back. For example, one manager described how canteen changes needed a balanced approach instead of drastic changes: “Simply only giving diet biscuit… people will become mad” and less healthy foods  need to be offered “once in a while.” A few sites created new print materials  to reinforce the messages taught in the INDIA-WORKS classes  and posted them in common areas, and another site provided nutrition information for canteen foods.Many sites leveraged existing health promotion programming to provide INDIA-WORKS participants and other workers guidance on healthy lifestyles, disease prevention, and disease management. Several sites regularly invited experts (including INDIA-WORKS study team members) to present on health-related topics. Other sites discussed health issues or reviewed worker health statistics at team meetings. One worksite has an extensive health library including digital educational tools and a health educator available to all workers as well as a health statistician, psychologist and other health providers on staff. One worksite, an occupational health industry, prioritized health programming ; INDIA-WORKS was easy to integrate and peer educators felt their roles in the INDIA-WORKS program were “part of job. That’s all. See we are here to prevent.” (Peer Educator).Most worksites delivered the INDIA-WORKS training program for peer educators without adaptations. Only one worksite hosted additional trainings sessions peer educators to help them master the material and improve comfort with teaching. At all sites, INDIA-WORKS staff providing on-going support and training. One INDIA-WORKS staff shared: “This is a completely new forte for them. I won’t be able to do their job if I am asked to. I might do it if you explain to me well enough. .. Some [peer educators] would even come to our rooms and ask us how to present a certain thing etc. We gave individual attention to everyone.”Scheduling (and rescheduling) classes around participant schedules, travel time to and around the worksite, production deadlines, and shift work was a “Herculean task” (Worksite Manager) and was discussed more frequently than any other adaptation barrier and across interview participant type. Similarly, sites with multiple worksites or a diversity of employee roles/positions found it challenging to find convenient schedules for classes and noted that program champions and staff had to gain support from management at each site or unit.Interviewees also noted that the teaching ability, confidence to lead, and dedication of the peer educators varied greatly across sites. For example, at one site peer educators often did not turn up for classes they were assigned to lead, leaving INDIA-WORKS staff to coach participants, while at another worksite peer educators engaged in teaching classes and leveraged the INDIA-WORKS staff to provide assistance with more complex lessons and tailor class scripts to the health literacy and education level of workers in their classes.INDIA-WORKS participants] were regularly doing the exercises by walking around the building. Once the privatization issue came up, people started blaming the lack of orders on this walking routine around the building. So the person in charge told me to avoid walking around the building and to walk on one side instead. This was based on the superstition that if one walks around a building, it causes a negative effect. So that caused people to lose their heart a little. INDIA-WORKS Staff[Concurrent with INDIA-WORKS (but starting before COVID-19-related disruptions), several worksites were affected by major organization-level challenges such as privatization and company shut down, which made it more difficult to adapt and deliver the INDIA-WORKS program. These challenges resulted in a lack of funds for implementation of environmental-level interventions like canteen changes and difficulty prioritizing the individual-level intervention for managers and participants. In addition, workers’ reactions to these challenges affected how peer educators, INDIA-WORKS staff, and managers were able to adapt the program at their worksites. For example, at one worksite where plans to privatize the worksite were being implemented, some employees at the site blamed the walking patterns of the INDIA-WORKS participants:Interview participants suggested additional content adaptations to consider in the future to improve sustainability and scalability of the lifestyle change program. Participants felt continued adaptations would be beneficial including timing and location of classes, variety of exercise types, and widening inclusion criteria. Interviewees suggested expanding the curriculum content by including additional diet and activity advice, information on worksite specific hazards , and more audio-visual materials. Peer educators, staff, and managers suggested that the class scripts will need periodic updates to make them fresh and appealing to workers: “things keep on changing. So, you should also keep on changing.” (Worksite Manager).Participants were conflicted about optimal timing and length for the program. Several peer educators and INDIA-WORKS completers suggested that longer or more frequent class periods were needed to cover all the material, provide individual feedback to participants, and do exercise classes, which were especially well received by people in their cohorts. Other interview participants suggested a shorter program ; these interviewees felt that shorter classes would improve participants’ attention and learning: “They come. They sleep. They fiddle the phone. You know attention span is maximum fifteen twenty minutes.… And in this small session, is only a small gathering. so, everybody is interactive.” (Worksite Manager).Other suggestions, mentioned by peer educators and INDIA-WORKS staff, focused on creating an environment that enabled Peer Educator success. Suggestions included scheduling classes around peer educators’ time first and expanding the training program for peer educators to include more role playing, visual examples, and additional training on lecturing/teaching to help them feel better prepared to lead classes.Integrated innovation theory posits that in order for an intervention to be successful in complex situations like community settings, it must integrate scientific/technological, social, and business innovations . INDIA-WINDIA-WORKS program adaptations included changes to the curriculum, recruitment or retention plans, and creation or use of health programming and resources at the worksites. The majority of adaptations were done during implementation to respond to the needs of the participants and worksite, although adaptations like language translation and changes to worksite exercise and food environments where adapted pre-implementation. Most adaptations were planned, reflecting the large number adaptable components in INDIA-WORKS. Unplanned adaptations occurred in reaction to unanticipated challenges with study recruitment, retention, and classroom logistics due to worksite-specific barriers or challenges. Other unplanned adaptations, such as adding additional cultural adaptation to diet lessons or new types of physical activity, where made in reaction to requests and interests of program participants. Participants’ requesting additional physical activity options might reflect improvements in fitness, as increased fitness can lead individuals to engage in a wider variety of exercise types .Except in one case (where a peer educator changed the order of lessons), adaptations were fidelity-consistent; this may have occurred because the program was carefully designed and presented to study partners with clearly defined core components, those necessary to program fidelity and aligned with proven behavioral health theories or strongly associated with program success in prior studies, and adaptable components which could be changed to be responsive and appropriate to the needs of the individual worksites . This isAll key players in overseeing program implementation, including worksite managers, INDIA-WORKS staff, and peer educators, were empowered to adapt program components. Adaptations by peer educators involved the program curriculum or participant retention, items which interfaced directly with participants, while INDIA-WORKS staff focused on adaptations necessary to the conduct of the study at each setting including tailoring of curriculum and recruitment methods to best suit the worksite environment and workers. Manager-led adaptations were often in areas requiring higher-level approvals and coordination . In Weiner, Lewis, and Linnan’s theory of the organizational determinants of effective program implementation at worksites, the authors argue that the complexity of implementing projects at worksites require active participation by both management and employees . Other sAlthough, delivering a diabetes prevention program at worksites in India at no monetary cost to the employee can overcome many of the barriers to lifestyle change , interview participants still described barriers to adapting the program to the worksites. These included unanticipated worksite changes and disruptions, the ongoing challenge of scheduling and rescheduling classes, and diversity of employees, which have been reported as barriers to worksite health programming in other studies , 45, 46.This study adds to the limited literature using the FRAME to describe program adaptations and modifications in the Indian context. Although the FRAME was able to categorize and describe most modifications with sufficient detail and clarity, there were some challenges to using the framework. Although various players were involved in suggesting program adaptations, implementation of adaptations always involved the worksite managers, with curriculum changes being the exception . India remains strongly hierarchal, and worksites reflect this top-down model . ManagerThere was also additional challenges in categorizing some of the modifications because of lack of clarity with definitions in the FRAME documentation. For example, we categorized adaptations to program recruiting and retention activities and scheduling of classes as content modifications because they related to the way the treatment  was delivered. Furthermore, these adaptations were not related to any of the categories of contextual modifications described in the FRAME . In practice, use of the FRAME to document and monitor program adaptations by worksites would be even more challenging, given lack of training and experience in implementation sciences.Finally, it was both time and resource intensive to document and categorize adaptations in detail and over time. To ensure we understood the full extent of adaptations, we conducted interviews with an array of key players involved in program implementation, and we continued interviews until data saturation was met. Each interview was then transcribed and coded, and thick descriptions were developed before categorizing the data using FRAME. This work was feasible given that this was a large, National Institutes of Health-funded study; however less resourced study teams or community-based evaluators may not be able to commit to work of this scope to properly document program modification and adaptations, leading to additional gaps in the literature on real-world implementation of health programs. Additional methodological development is needed to understand how to efficiently document program adaptations on an on-going basis, and how to best use this information to continuously improve interventions during implementation.This manuscript describing adaptations to the INDIA-WORKS intervention program has several notable strengths. Although there is tremendous growth in the number of community-based interventions, reporting of program adaptation is still limited and often done non-systematically , 49. AdaHowever, the FRAME did not guide data collection. Instead, the framework was applied during data analysis to capture information on modifications emerging in the data. This could result in missing data including not all modifications being identified or fully characterized. Similarly, using in-depth interviews only to track adaptations might lead to underreporting of program changes. Future studies of this type should consider using the FRAME and mixed methods data collection systematically to describe and track adaptations in real time. Similarly, although we interviewed a variety of stakeholders involved in the program implementation, including program delivery personnel, managers, and participants, the qualitative data collection was not focused primarily on understanding adaptations, and all worksite-specific changes might not have been captured.Lastly, we did not explore how specific modifications and adaptations influenced implementation success and intervention effectiveness. The COVID-19 pandemic precluded further qualitative data collection at sites and made collection of additional information from the already-overburdened worksites practically impossible . Future studies should evaluate various adaptations for improving participation, retention, program delivery, and indicators of program effectiveness like weight loss. However, there is still great value in reporting program modifications. Very little is known about how programs are adapted in general and in low -and middle-income countries and worksites, specifically. This study goes beyond simply describing planned program methods to provide important guidance on how the program was delivered at individual worksites. This information can be used to help with program scaling and guide other researchers and program planners designing similar programs. Documenting unplanned modifications is particularly important as they can be proactively considered in the future to ensure all adaptation are fidelity consistent. Similarly, this work can be used to help with the design and planning of worksheets and other documentation for recording adaptations and provides documentation to assist in manualizing the intervention for broader dissemination .In conclusion, this manuscript describes and characterizes, using the FRAME classification system, worksite specific adaptations to the INDIA-WORKS intervention. Sites reported adaptations to the curriculum, participant recruitment and retention, and worksite health resources. This study adds to the growing literature reporting on program adaptations in implementation research in general and is one of the first to specifically describe implementation of lifestyle programs for disease prevention at worksites in India.


Older adults with frailty are at an increased risk of adverse outcomes after surgery. Exercise before surgery (exercise prehabilitation) may reduce adverse events and improve recovery after surgery. However, adherence with exercise therapy is often low, especially in older populations. The purpose of this study was to qualitatively assess the barriers and facilitators to participating in exercise prehabilitation from the perspective of older people with frailty participating in the intervention arm of a randomized trial.This was a research ethics approved, nested descriptive qualitative study within a randomized controlled trial of home-based exercise prehabilitation vs. standard care with older patients (≥ 60 years) having elective cancer surgery, and who were living with frailty . The intervention was a home-based prehabilitation program for at least 3 weeks before surgery that involved aerobic activity, strength and stretching, and nutritional advice. After completing the prehabilitation program, participants were asked to partake in a semi-structured interview informed by the Theoretical Domains Framework (TDF). Qualitative analysis was guided by the TDF.Fifteen qualitative interviews were completed. Facilitators included: 1) the program being manageable and suitable to older adults with frailty, 2) adequate resources to support engagement, 3) support from others, 4) a sense of control, intrinsic value, noticing progress and improving health outcomes and 5) the program was enjoyable and facilitated by previous experience. Barriers included: 1) pre-existing conditions, fatigue and baseline fitness, 2) weather, and 3) guilt and frustration when unable to exercise. A need for individualization and variety was offered as a suggestion by participants and was therefore described as both a barrier and facilitator.Home-based exercise prehabilitation is feasible and acceptable to older people with frailty preparing for cancer surgery. Participants identified that a home-based program was manageable, easy to follow with helpful resources, included valuable support from the research team, and they reported self-perceived health benefits and a sense of control over their health. Future studies and implementation should consider increased personalization based on health and fitness, psychosocial support and modifications to aerobic exercises in response to adverse weather conditions.The online version contains supplementary material available at 10.1186/s12877-023-03990-3. Older adults i.e., ≥ 65 years) are a rapidly growing demographic and represent the majority of people who have major surgery , 2. Four years arExercise prehabilitation  has been identified as a promising intervention to address the vulnerability to physical and physiological stressors  that individuals with frailty encounter , 11–13. Theory-based behaviour change frameworks can be used to design interventions to improve adherence to target health behaviours, such as prehabilitation. A leading behavior change framework is the Theoretical Domains Framework (TDF) , which cThis was a nested descriptive qualitative study , 24 withThis qualitative research study was situated with the Social Constructivist  paradigmThe TDF was used to guide the interviews, while recognizing that there is not one objective truth. The TDF is a behaviour change framework that comprises 14 theoretical domains derived from 128 constructs from a synthesis of 33 different theories of health, behavioural and social psychology that explain changes in health-related behaviour , 28. TheThe research team included the Principal Investigator, a male Anesthesiologist and health services researcher with expertise in perioperative medicine and frailty (DIM), a female PhD candidate in Aging & Health with a Masters degree in Counselling Psychology and experience with prehabilitation for older adults (EH), and two female clinical research assistants, one with a Masters in Human Kinetics and experience with the TDF (KD) and one with a Masters in Exercise Psychology and experience with qualitative interviews (CS).Patients were eligible to participate in the main PREHAB Study if they were ≥ 60 years of age, lived with frailty based on the Clinical Frailty Scale  and were invited to participate in an interview at a time convenient to them. Interviews were conducted by trained clinical research assistants . Interviews were conducted by telephone, were digitally recorded and transcribed verbatim. The interviewers verified the content for accuracy. Any information that could potentially identify the participant was removed from the transcripts. The interviews ranged in length between 4 and 10 min. Transcripts were uploaded to and analyzed using NVivo 11 Software.Our sample size was based on information power, a concept related to a narrow study aim, dense sample, and high quality and structured interviews, ultimately providing new knowledge that is aligned with the study aims . We achiThe analysis followed a 3-step iterative approach: (1) coding, (2) generation of specific beliefs, and (3) generation of specific themes. Analysis and interviews occurred concurrently. First, transcripts were coded independently by two research assistants using conventional deductive content analysis . The codWe worked as a team to ensure rigor was maintained throughout the course of this study. We kept thorough record of coding by two coders and the decisions made to reach consensus which provides an audit trail including notes made by the research team. Importantly, team members engaged in reflexive dialogue throughout data collection and analysis , 38.Fifteen participants  from The PREHAB Study consented to participate in the semi-structured interviews. The average age was 72 years; the median CFS score was 4; the average number of weeks in the exercise prehabilitation program was 5. Within the 6 months leading up to surgery, two participants received neoadjuvant chemotherapy and one participant received neoadjuvant radiation therapy. See Table Beliefs about capabilities); 2) Weather (Environment); 3) Guilt and frustration when unable to exercise ; 4) The program being manageable and well-suited for older adults with frailty ; 5) Adequate resources to support engagement with the program (Environment); 6) Support from others helps with self-perceived adherence ; 7) A sense of control, intrinsic value, noticing progress and improving health outcomes ; 8) Enjoyable and facilitated by previous experiences ; 9) A need for individualization and variety . Key themes and belief statements acting as barriers are presented in Table Nine key themes were identified, and aligned with 10 of the 14 domains of the TDF (relevant TDF domains denoted in parentheses): 1) Pre-existing conditions, fatigue and baseline fitness . Some participants expressed that these physical limitations reduced the amount of time that they could spend exercising, while for others, limitations were related to the specific exercises they could perform.A feeling of tiredness was also commonly identified as a pre-existing barrier. For some participants prevalent tiredness impacted their ability to exercise on a given day , while for others fatigue set in while exercising .For some participants, existing health status presented a challenge when starting the program . However, as the program advanced, some participants found it easier to participate .Adverse weather conditions were identified as a barrier to participation, particularly for the aerobic component of the program. In some cases, heat and humidity impacted participant’s motivation to exercise . Cold and winter weather were also identified as barriers .We identified belief statements related to guilt and frustration from participants when they were unable to exercise. In each case this was identified as a barrier as participants did not frame their experience as motivating; negative emotions were expressed .All participants believed the program was easy to follow, which was identified as an important facilitator , while environmental aspects, such as the home-based structure of the program, further facilitated participation .Participants also consistently expressed beliefs that a lack of exercise related skills did not act as a barrier to participation . Teaching and support provided via multimodal instructions helped to guide successful participation in the program . The program was also felt to be well suited to the needs and capabilities of participants, proving a challenge but not being overly difficult to de-motivate . Finally, attainable goals appeared to facilitate participation .Program materials and structures were identified as facilitators to participation. Participants expressed that provision of written and audiovisual guides helped them to participate . It was also identified that follow up provided via telephone during the program supported participants in successfully exercising .Participants identified the importance of social influence via support from family and friends as important facilitators to participation . Furthermore, completing exercises with another person also supported completion of prescribed exercise .Participants identified thinking that participating in prehabilitation helped them to feel like they were impacting their own care in a way that would benefit them in the longer term. These beliefs appeared to facilitate participation through influence on participant’s beliefs about consequences of their exercising  and their role in impacting their health outcomes . Participating in exercise was also identified as motivating participants toward their goal of achieving a positive surgical outcome Successful completion of exercises and a sense of improvement in performance over time also appeared to facilitate participation .Enjoying participation in the prehabilitation program appeared to reinforce and facilitate adherence to exercise before surgery . Furthermore, having past experience with exercise appeared to further facilitate participation .This theme was identified as both a barrier and a potential facilitator and is therefore included in both Tables In this qualitative study of older patients with frailty participating in a home-based exercise prehabilitation program prior to cancer surgery, we identified patient-reported barriers and facilitators of adherence to exercise that aligned with 10 of the 14 domains of the TDF. As adequate adherence is likely a key mediator of prehabilitation efficacy, future program design should consider approaches that leverage facilitators and overcome barriers that we have identified. Key facilitators appear to include that the program was manageable and suitable to older adults with frailty, there were adequate resources to support engagement, and participants felt a sense of control over their health and their health outcomes. Furthermore, older adults with frailty expressed no need for previous experience, and perceived better adherence when social support from family or an exercise partner were available. Successful programs will need to identify means to overcome barriers such as pre-existing fatigue and physical ailments, impacts of adverse weather conditions, and emotional support when feelings of guilt or frustration occur where sessions are missed. A need for individualization and variety within the program was offered as a suggestion by participants and was therefore described as both a facilitator and a barrier. Future studies should explore using a tailored approach to prehabilitation targeting individual needs of participants. Individualization could include providing different levels of exercises and equipment, modifying the program based on limitations and skills and exploring exercise options using an interests-based approach.Adherence to prescribed exercise is consistently identified as a challenge in studies aimed at leveraging physical activity to improve health , 40. PriAlthough initially developed to guide implementation science related to health professionals’ behaviour, the TDF has since been used to assess barriers and facilitators to behavior change in a variety of settings, including for patients . While qPrevious qualitative assessment of patients’ perspectives regarding prehabilitation have not focused on patients with frailty, but highlight several findings consistent with barriers and facilitators identified in the current study , 45. SimThe literature regarding adherence with exercise therapy in older people with frailty is sparse. Available reviews have either simply reported adherence rates , focusedThis study should be considered in context of its strengths and limitations. As a qualitative study, results could be influenced by a variety of factors, including intrinsic biases of interviewers, coders and researchers. While we used best practices to recruit our sample and to achieve data adequacy, there may be selection bias as our participants were individuals willing to both participate in a randomized trial of prehabilitation and a nested, qualitative study. The current study focuses on people living with frailty who required oncologic surgery. The duration of prehabilitation was generally in line with other programs described in the literature , 18, 35.For older people with frailty participating in exercise prehabilitation before cancer surgery, many facilitators to program adherence align with those of patients without frailty, including the intrinsic motivation of improving one’s health before surgery, having social support and the use of purpose designed and personalized programming. Future programs should leverage these facilitators while considering novel barriers such as limitations due to poor baseline health, adverse weather conditions, and need for emotional support. Continued, iterative implementation and re-evaluation of barriers and facilitators may be required to ensure older people with frailty achieve adequate adherence to benefit from prehabilitation.Additional file 1. COREQ  Checklist.Additional file 2. Interview Guide.Additional file 3. Supportive Quotes for Each Belief Statement, Grouped by Theme.


A crisis is defined as a disruption in equilibrium at the failure of own personal resources which results in important distress and functional impairment. Particularly after Covid-19 pandemic we have been attending an increased number of this kind of consultations in the mental health services.To expose a new mental health program called PAIC (Ambulatory Intensive Community Program) started in March 2019 and addressed to people who are suffering a crises period, and to evaluate its effectiveness. The aim of this program is to reach prior stability, trying to avoid chronicity, clinical status perpetuation and sociofunctional impairment, as well as assessing suicidal risk and perform early prevention interventions.LTE and Clinical Global Impression (CGI-I). Changes in CORE-OM Scale were analysed using t-student test and a descriptive analysis was used for CGI-results.PAIC is proposed as an early, intensive, focused and psychotherapeutic intervention led by psychiatrist. Consist in an 8-week program of 30 to 60 minute weekly individual sessions. A total of a 205 patients were attended in PAIC during 2021 and 84,6% of the patients completed the program. Mixed-methods, clinical interviews and measurements using validated self-administrated questionnaires were used: CORE-OM pre/post treatment , List of Threatening Experiences, CORE-OM  showed improvement in all of four dimensions: subjective well-being (TW), problems/symptoms (PT), general function (TF) and risk (TR).Perception of clinical improving measured by CGI was 81,6%. There were no cases of clinical worsening.We conclude that intensive and early programs are effective reducing the intensity of symptoms and the level of disability in people who are experiencing a psychological crisis. Also, it supports primary health care as well as helps to avoid saturation of specialized system.None Declared


Although social and emotional learning (SEL) benefits children and youth worldwide, classifying a program as SEL is insufficient to capture its variability of content. There is currently little to aid in identifying specific program content so that foci may be identified . This gap poses a difficulty for researchers attempting to address heterogeneity in SEL research and practitioners who want to select programs best suited for their contexts. This paper begins to address these concerns by extracting and contrasting ‘core components’ of interventions within an identified shortlist of 13 universal, elementary evidence-based programs through a distillation method using the often cited ‘five core competency’ model from CASEL . Results showed that CASEL’s core competencies are represented across short-listed programs. However, almost all programs had identifiable foci, targeting a subset of skills. Accordingly, the use of ‘core components’ is recommended as a method for offering more nuance in SEL classification for programs beyond the current study, with implications for program implementation and the design of future research in SEL evaluation. Therefore, there is a potential risk that implementers may assume that SEL programs typically address all competencies. Even without assuming an SEL program offers content in all key areas. Practitioners are still not optimally equipped to select the best program for their contexts without further information.Social and emotional learning (SEL) is the process whereby children and young people learn a broad range of social, emotional, and behavioral skills . Such an approach is consistent with a contemporary paradigm in respect to adopting evidence-based practice  and interpersonal skills . Notably, in an examination of 15 evidence-based programs selected from CASEL’s guide for elementary schools, Lawson et al.  are usen et al.  observedRecent innovative work similarly demonstrates proof of concept by ‘dismantling’ several popular programs and identifying specific skills. Jones et al.  distilleOpportunities for greater nuance in understanding SEL’s core components will benefit implementers and researchers. Providing better articulation of program specifics will offer a more nuanced categorization of SEL programming, with implications for fit for local context and refinements in future research when comparing program types.Accordingly, the current study aims to examine content information of an identified short-list of evidence-based SEL programs to see whether a method of program categorization can be established.across programs. The current study instead focuses on the prevalence of elements within programs, offering greater detail regarding available programs currently deployed in educational settings.The current study builds on previous work by drawing on the same dataset from Wigelsworth et al. . This stContact with the authors’ networks and expert organizations  requesting relevant sources.Systematic searches of bibliographic databases .A review of reviews—meta-analytic and systematic reviews were examined for relevant literature .Google Scholar was utilized to further identify any grey literature, as recommended by Haddaway et al. .Subsequent reference harvesting from identified sources was also used.As per Wigelsworth et al. , a shortScoping was conducted for reviews published or made available between 31st December 1995A rerun of the original systematic search using PsychINFO  with amended search dates (June 2018–November 2022). Any identified randomized trials of SEL interventions were collated and compared to the list of original programs identified (per the protocol specified below).A search of all program websites identified in the initial search. Evidence on each website  were compared to the criteria below to see whether they were eligible for inclusion .Following Covid-19 disruptions, delaying the research preparation for publication, an updated search strategy was deployed to cover June 2018  to November 2022. This update ensured that no new programs had subsequently met the evidence threshold and should be included in the analysis. The updated strategy was as follows:No new eligible programs were found as a result of the updated search strategy.As per Wigelsworth et al. , programFor each identified program, the full curriculum and any accompanying materials were examined and coded. Consistent with the distillation approach , a cross section of grades was chosen for coding . Roots of Empathy was the least structured program, presenting a guide of activities to be delivered throughout the school year. Although all programs recommend a regular delivery schedule, there was a notable variability in the length of programs, with some offering as few as 10 sessions, and others offering more than 100 Table .Coding showed that program foci varied by core competency, with identifiable foci for all but one curriculum Table . ProgramAs Table Tables Through the distillation of core components, this study identified program foci, offering a more nuanced and differentiated representation of SEL provisions than currently available. Using distillation as a method, researchers identified the content of individual programs and examined the proportion of core competencies within each one. A categorization of program foci by which programs showed a particular emphasis on a subset of skills was then proposed. Thus, this process was demonstrated as a feasible method for providing more content information to support program categorization, which the researchers advocate.Despite programs being commonly collated under the singular title of SEL and sharing an assumed common-evidence base  do not provide sufficient detail for more nuanced choices. Fit to context is associated with successful outcomes . There is already some tentative move toward demonstrating the potential efficacy of such an approach. For example, Jones et al.  demonstrhypothesized model of SEL. Perhaps programs with foci in otherwise undeveloped areas  have yet to accrue a sufficient evidence base to be reflected in the current short-list of programs, as per the current study’s threshold for demonstrating the evidence of success. Extant work in the field would potentially support such a hypothesis. For instance, Jones and colleagues’ . Moreover, within these programs, these skills represent less than 2% of the program content. Lack of skill coverage is also true for ‘organizational skills,’ contained within CASEL’s core competency of self-management. Only two programs were identified as including content addressing this specific skill (FRIENDS and Positive Action) and, again, representing less than 2% of the program content. There is a question as to whether the current evidence base of SEL programming sufficiently covers the full range of skills associated with the leagues’  review oleagues’  showed tproximal or immediate outcome of self-regulation . A further explanation is that for both Jones et al. and the current study, programs with a focus on self-management skills are identifiable though alternative frameworks. Search terms for both studies required identifying social terms, emotional terms, or both, which precludes more focused frameworks. For instance, Boekaerts’ dual-processing self-regulation model . Implications arise for implementors for identifying and selecting programs regarding their intended outcomes  and for program developers regarding content coverage . This lack of a consensus about the precise constructs contained with SEL Schoon,  is an isAs a brief and final point, there is an implication for research regarding the potential use of identified program foci as an attempt to address long-standing issues with prominent levels of heterogeneity that have plagued meta-analytic studies in this area  and broader approaches, such as changes to school-wide climate and culture . Such approaches will have their own challenges, requiring different coding frameworks. Thus, they are beyond the scope of this paper.A further consideration is selecting CASEL’s core competencies and specific skills as the study’s frame of focus. As briefly discussed above, there are alternative frameworks for considering SEL. In this respect, other elements of program content may have been forfeited. For instance, mindfulness and character are related to wider definitions of SEL Schoon, . HoweverThe current study findings indicate a revised and more nuanced picture of SEL provision than what is currently available through a process of identifying core components and subsequent classification of program foci. In turn, a suggestion is generated that there may be key gaps in the provision of CASEL’s full spectrum of core competencies when considering only those programs with a robust history of success. Given the global ubiquity of SEL programming, there is increasing consideration of the importance of context and fit for SEL programming (Oberle et al.,