Promotoras led experiential nutrition education sessions and collected height, weight, and instant skin carotenoid scores (biomarker for FV intake) at pre-test (baseline), post-test (6 weeks), and maintenance (3–4 months after post-test). Mean changes and group differences in skin carotenoid scores, BMI z-scores and percentiles were obtained from analyses of variance. Linear mixed-effects models were used to determine overall program effects. Mexican-heritage children were enrolled . An overall decrease in skin carotenoid scores was observed at post-test . While scores varied widely (range: 17–498), an increase of 14.8 ± 23.8 points occurred in one intervention group. Compared to the control period, greater reductions in BMI outcomes occurred during the program. These findings provide evidence for the use of strengths-based approaches in behavioral nutrition programs.Systemic and social factors, like poverty and food insecurity, negatively influence fruit and vegetable (FV) intake and body mass index (BMI) among Latino/a children. Behavioral programs are needed to support children’s nutrition. This study examined program effects on FV intake and BMI outcomes for Mexican-heritage children (9–11 years). The program used a modified stepped-wedge design in the Lower Rio Grande Valley of Texas (2019 and 2020).  Systemic, structural, and social factors, like poverty and food insecurity, negatively influence nutrition for Latino/a children living in border communities ,2,3,4. SThere is an opportunity for health promotion to support nutrition and physical activity for Latino/a children living in limited-resource households and rural communities, including Texas–Mexico border communities, but few nutrition interventions or programs have been designed, implemented, or evaluated for this population. Exemplar interventions for Latino/a children include Crespo et al., Davis et al., and Barragan et al. ,6,7. PriHaz Espacio para Papi!  program was a novel and theory-based program for Mexican-heritage families living in border communities in the Lower Rio Grande Valley of Texas [® and (2) body mass index (BMI) evaluated with age- and sex-adjusted BMI percentiles and BMI z-scores. Findings from this study are an important step in designing culturally relevant and sustainable programs for Mexican-heritage children living in border communities.To date, there have been no family-centered behavioral nutrition programs for Latino/a children living in border communities. The ¡of Texas ,13,14. SPromotoras completed the pre-test within two weeks of the program start, completed post-test within two weeks of the program conclusion, and the maintenance within three to four months after post-test. During this time, the COVID-19 pandemic occurred and there were disruptions to program implementation and evaluation. The HEPP program was developed by an interdisciplinary and multi-institutional team. The team consisted of academic-based public health researchers, who had experience and training in nutrition, behavioral and social health, and physical activity, a licensed family psychologist who had expertise in working with Latino family systems, and promotoras that received training and had experience in education, research, and social work. Promotoras played a critical role in the design, implementation, and evaluation [This manuscript reports on an outcome evaluation of the six-week HEPP (Haz Espacio para Papi | Make Room for Daddy!) program. HEPP utilized a pre-test/post-test (or “pre-post”) design, specifically a modified stepped-wedge design with a comparison wait-listed control or delayed intervention group . The ¡Haaluation ,13, as paluation ,16. The aluation .Promotoras and community partners helped to recruit families through flyers, word of mouth, and going door to door. As recommended by Panter-Brick et al. and others, the promotoras verbally highlighted the uniqueness of the HEPP program and the importance of it to fathers and the whole family [Prior to recruitment, all materials were approved by the Institutional Review Board (IRB) at Texas A&M. Additionally, collaborating institutions reviewed and approved applications for data analyses. The proposed analyses were submitted and approved by the Texas State University IRB on 27 August 2021 (IRB Protocol #7973). The HEPP program purposefully recruited Latino fathers and mothers. e family ,20,21,22Eligible parents had to self-identify as Mexican-heritage  and be 21 years old or older. Parents also needed to live with their spouse/partner and child (aged 9 to 11 years old), be willing to complete in-person measurement visits at their home for both the pre- and post-test measurements and commit to participate for the full six weeks. Parents and children were excluded from participating if they disclosed having a severe food allergy or physical activity restrictions ,23,24.The HEPP program recruited 10 to 12 families from each cluster of colonias (neighborhoods), which were geographically defined within the study area in the Lower Rio Grande Valley of Texas. Program groups were defined based on the neighborhood clusters, and this program recruited from five clusters of colonias (five groups). One group of 10–12 families participated in the program at a time. Each family had one child participating in the program. Random assignment was used to determine which group would start as the intervention (treatment) group and as the wait-listed control.promotoras, and literature. A Spanish and English informed consent form was developed at or below a fifth-grade reading level with visual aids and graphics to help participants understand the program commitment, research activities, potential risks, and potential benefits. After parental consent, eligible children were asked for their assent to participate in the program. Fathers, mothers, and children received $100 for pre-program visits, $200 for post-program visits, up to $200 for attending all six sessions ($500 per family/household), and a kitchen (food preparation and cooking) kit worth $100.Development of the informed consent process was done in collaboration with the research team, the A separate article describes the theoretical foundation and provides a conceptual framework for the HEPP program . BrieflyPromotoras led in-person group sessions that included a food and beverage tasting for participants with a “mini” nutrition education lesson, an interactive lesson for participants to gain knowledge and skills related to nutrition and family functioning, child-focused cooking lesson, and eating together lesson. Promotoras also led weekly check-ins . The nutrition curriculum focused on embracing traditional and cultural foods and food preparations while learning new ways to enjoy beverages, snacks, sides, and main dishes. Every week, a new “spotlight” fruit or vegetable was featured, which included garbanzo bean (chickpea), jicama, cabbage, spinach, sweet potato, and avocado. Most recipes required no animal proteins and were plant-based or vegetarian preparations [HEPP was a six-week program that consisted of three intervention components: weekly in-person group sessions, check-ins , and at-home activities that occurred between the group sessions . The proarations . A separarations .promotoras collected all data simultaneously in person at the homes of participating families [promotoras collected data privately from each family member during the visit. They (promotoras) collected data using several techniques: interviewer-administered surveys (sociodemographic data including food security), accelerometry , anthropometry (measured height and weight), and reflection spectroscopy with the Veggie Meter® to obtain instant skin carotenoid score, which is a biomarker for dietary fruit and vegetable intake.A team of families ,13. DiffThis study was affected by the COVID-19 pandemic. Originally, the study planned assessments at transition (key for modified stepped-wedge study design), baseline or pre-test (within two weeks of program start), post-test (within two weeks after program completion), and maintenance (three to four months after post-test) for all groups  prior [®. Skin carotenoid levels measured by an RS device are an accurate and validated way to measure plasma carotenoid concentrations in children and adults [® is promising for use with individuals across a range of skin tones, and the device automatically adjusts for differences in melanin [The Veggie Meterd levels . The devd levels . The devs) prior . Severald adults ,32,33,34d adults . Furtherd adults . Similard adults . Evidenc melanin ,32.® devices in the summer of 2018 and started training, withs limited information on best practices for Veggie Meter® use. Instructions outlined the importance of calibration with dark and white reference sticks before use, re-calibration at least every two hours during continuous use , handwashing before assessment, and completing a triple scan on the same finger to obtain an average instant skin carotenoid score. Given the nature of data collection in semi-rural communities like the colonias, the promotoras traveled with a portable table for the RS device and laptop, sanitizing wipes, and paper towels to complete the Veggie Meter® assessments. Promotoras using the Veggie Meter® followed a study protocol that included traveling with a fully charged Veggie Meter® laptop, calibration before each home visit, setting up the device on a portable table, and ensuring that participants washed hands before assessment. Handwashing helped to remove residual staining from any highly pigmented foods or remnant splotches from colored markers or paint [promotoras used the average setting (versus relying on a single scan), which meant that each child completed three consecutive scans of the same finger to improve reliability [Promotoras completed Veggie Meter® scans at each time point  and documented which finger was scanned and any comments regarding protocol deviations. ®, out-of-range scores, and the range of scores at each measurement visit.For this study, the team acquired two Veggie Meteror paint . The proiability . PromotoPromotoras obtained measured height (in inches) and weight (in pounds) with a portable stadiometer and digital scale at each time point . They followed a recommended protocol for obtaining height and weight measures and completed three consecutive measurements of height and weight to improve reliability [Body Mass Index (BMI) was assessed using age- and sex-adjusted BMI percentile and BMI z-scores based on the 2000 CDC (Centers for Disease Control and Prevention) BMI-for-Age Growth Charts . The CDCiability . Averageiability . Data oniability .a priori sample size calculation to determine the minimum number of children in the treatment (or intervention) group. This manuscript used all available data from the children who participated in the HEPP program. Of the 59 children enrolled, promotoras completed measures at pre-test for 57 children, post-test for 42 children, and maintenance for 24 children. Like prior studies, analyses focused on determining within-person changes in instant skin carotenoid score and BMI outcomes overall, by group and examining group differences [post = post–pre) and from post-test to the end of the maintenance period (changemaintenance = maintenance–post) were calculated. To determine within-person changes in outcomes during the control period, changes from the transition period to pre-test were calculated (changecontrol = transition–pre). When each group underwent the intervention, the subsequent group served as the preceding group’s control. For example, when group 2 underwent the intervention, group 3 served as the control for group 2. Changes in group 2 skin carotenoid scores between pre- and post-test were compared to changes in group 3 skin carotenoid scores between transition and pre-test. Given that the HEPP nutrition program was a pilot study, there was no ferences . To detep < 0.05. Prior studies were used to interpret results from analyses.All data were analyzed using SAS  and Stata . Unadjusted descriptive analyses were used to determine overall and group means for child age in years, instant skin carotenoid score, BMI z-score, BMI percentiles and group distributions by sex, BMI percentile categories and food insecurity status at pre-test measure. Fisher’s exact tests were used to determine differences in the distributions of categorical variables and analysis of variance (ANOVA) was used to test differences in means of continuous variables. To obtain mean pre- to post-test and maintenance to post-test changes for each outcome, six unadjusted ANOVAs were conducted with each within-person change outcome as the dependent variable and group as the independent variable. To determine whether mean within-person changes in each outcome differed by group, three separate ANOVAs were conducted with each within-person change outcome as the dependent variable and an interaction of data collection time point and group as the independent term (time x group). These analyses compared changes in outcomes from pre- to post-test for intervention groups to the changes from transition to pretest for the control groups. Additionally, changes in outcomes from post-test to maintenance for intervention groups were compared to the changes at post-test measures for the control groups. Stata’s margins command was used to obtain unadjusted mean within-person changes in instant skin carotenoid scores, BMI z-scores and BMI percentiles overall and by group from each ANOVA. Linear mixed-effects models were used to determine the overall intervention effects on changes in instant skin carotenoid scores, BMI z-scores and BMI percentiles. Mixed models account for the hierarchical structure of the data, are recommended for use with a stepped-wedge study design ,40, and Promotoras screened 308 families for eligibility in the HEPP program, and 61 families met eligibility requirements. Families were recruited from five geographic clusters of neighborhoods (colonias). Two families dropped out before pre-test measures and the program enrolled 59 families or 59 children. The program dose delivered was 900 h for the child (six sessions at 2.5 h per session). The mean number of sessions attended was highest for group 1 (5.6 sessions); on average other groups had between 4.7 and 5.4 sessions . UnfortuRegarding BMI outcomes at post-test, the average BMI percentile change was −0.34 ± 0.4 , which meant that BMI percentile decreased between pre- and post-test. The overall average change for control groups was an increase of 0.44 ± 0.41 for BMI percentile. Group 3 had the most noticeable decrease in BMI percentile (intervention: −3.3 ± 1.6 versus control: −0.58 ± 1.5) at post-test. A similar pattern was seen for BMI z-score.Regarding BMI outcomes at maintenance, the average BMI percentile change was −1.6 ± 0.37 , which meant that BMI percentile decreased between post-test and maintenance. Group 2 had the most noticeable decrease in BMI percentile (−2.5 ± 0.68) at maintenance. Groups 1–3 reported reductions in BMI at maintenance (three to four months later). A similar pattern was seen for BMI z-score.This study examined the effects of the HEPP program on instant skin carotenoid score, as a biomarker of fruit and vegetable intake, and age- and sex-adjusted BMI at post-test and maintenance. Overall, the results showed that the HEPP program had no statistically significant effects on instant skin carotenoid score or BMI for Mexican-heritage children at post-test, based on unadjusted and adjusted models. In addition, there were no statistically significant within-person changes by groups aside from dose for group 5. However, for some groups, associations were in the hypothesized direction, and there were greater effects for the program (intervention) group compared to the control group for BMI outcomes, which provides some evidence for program effectiveness.Preliminary evidence from this program is promising. In the U.S., systemic, structural, and social factors, like poverty and food insecurity, disproportionately affect Latino communities, which means that Latino households have not had resources or opportunities to support adequate nutrition. For example, based on the U.S. Department of Agriculture’s (USDA) most recent report, food insecurity prevalence was 10.8% in Hispanic households with children compared to 3.6% in non-Hispanic white households with children in 2021 . Althougpromotora group leaders/interventionists over time. Another reason may have been peer learning or social support that participants experienced in this group 3 [Findings highlighted interesting patterns between groups, likely related to group variations in program retention and timing of delivery. For example, group 3 consistently reported greater changes in outcomes compared to the other groups at post-test and maintenance. One reason for the larger effect sizes may have been gains in confidence or skill of the  group 3 ,10.® scores at post-test (and an increase relative to control group). When school was not in session, children may have had limited access to fruits and vegetables through the school meal programs and benefited more from the HEPP program. When school was in session, children likely had greater access to fruits and vegetables, through the school meal programs, including the Community Eligibility Provision [® score. School lunch programs have been shown to increase the selection and dietary intake of fruits and vegetables [® score for children in groups 2, 3, and 4, who participated in the HEPP program during the school year and may have had access to school lunch programs. Yet, our results showed reductions in Veggie Meter® scores for some groups, which suggests that children’s access to fruits and vegetables through school lunch meals program may have been insufficient to affect instant skin carotenoid score.Results also generated important insights related to school lunch programs. Group 1 was the only group that started and finished the program during the summer and the only group with an increase in Veggie Meterrovision , and incgetables  in childgetables . Furthergetables . We expe®, which was a relatively new device at the time. Available evidence from Veggie Meter® studies now indicates that the exposure period is about eight weeks [®. The promotoras documented numerous issues with residual food staining, which initiated a protocol deviation or changing the finger for assessment. Anecdotally, when the promotoras scanned a different finger, the score was quite different. The small sample size and large variation in Veggie Meter® scores likely made it difficult to estimate effect size. To date, though, there has been limited published research on using Veggie Meter® with Latino children or adults [® with Latino/a children living in border communities and only one study that obtained Veggie Meter® scans at more than one time point for a subsample of Latino/a children [A couple of points warrant additional discussion. First, the program evaluated its primary outcome of dietary intake of fruits and vegetables with the Veggie Meterht weeks . Howeverr adults ,48 and fr adults ,50. Howechildren .® in community-based research. First, the Veggie Meter® is a rapid assessment, and assessments only take a couple of minutes. There is no additional data entry and sources of error are reduced. Second, the Veggie Meter® is a small and lightweight device and easy to transport. Third, the non-invasive nature of the assessment reduced the burden and increased the acceptability of the program, which was grounded in community-engaged research. This allowed for inadequate fruit and vegetable intake to be identified and to evaluate the success rates of intervention programs that aim at increasing fruit and vegetable intake in study participants [promotoras shared that the Veggie Meter® was quick and easy to use for them, and accepted by families, especially for children.Based on the team’s experience, there are several practical benefits to using the Veggie Metericipants . Anecdot2 less than those in control group over the three-year period [Second, this program evaluated BMI in growing children. Findings showed that the program resulted in a decrease in BMI outcomes at post-test and maintenance. Program effects may be attributed to the family functioning, nutrition, or the physical activity components of the program ,13,14. Tr period . The effr period ,55; howe® meant that there was not a standard research protocol for how to use the Veggie Meter® available at the time of the program. The research team overcame this barrier by developing a protocol (described in the methods) that outlined conducting scans on the right index finger for all children, unless there was a reason to use the left hand due to residual staining or “out of range” scores. However, recommendations published in 2022 suggested that scans use the non-dominant ring finger, which was not done in this study. Because of the timing, and recommended protocol being unavailable [This study is not without limitations. First, the sample size was relatively small (59 children enrolled and 41 children with pre- and post-test data). The design, implementation, and evaluation required tremendous resources, which limited the number of families that were able to participate. Prior studies, family-based nutrition interventions, have included samples of between nine and 356 children ,58,59. Available , finding®, as an objective measure of dietary intake, was a strength and sets this program apart. Validation studies have shown a high correlation between Veggie Meter® scores and serum carotenoids, which is a more reliable way to measure fruit and vegetable intake compared to self-reported dietary recalls and food records, which are prone to inherent bias and inaccurate estimates [promotora model, use of theory, and targeting family functioning to engage fathers, mothers, and children as a family system [At the same time, use of the Veggie Meterstimates ,35,65. Astimates . This ststimates ,67,68,69y system ,13. Addi® was a relatively easy assessment for promotoras and acceptable to the Mexican-heritage children. The device provided a rapid, non-invasive, and portable way to obtain an objective measure of dietary intake [® may make it difficult for community-based organizations or researchers to acquire. Using the Veggie Meter® for research offered several advantages, including using an objective measure to evaluate the program, portability, and minimizing sources of error in data entry. However, future research is needed to create standardized protocols or best practices for research with the Veggie Meter® and create a data repository of Veggie Meter® scores for different subpopulations, including children from different racial and ethnic backgrounds, ages, and genders. Protocols will support validity and reliability of findings and a data repository will help with data interpretation, especially for special populations, including children. Given that the Veggie Meter® reflects a reference period of about eight weeks [promotora model and theory-based design [Findings offer implications for practice, research, and policy. First, the Veggie Metery intake  and may ht weeks , this asd design ,13. The d design . Additiod design . There mpromotoras documented numerous issues with residual food staining that affected the consistency of the Veggie Meter® scans, and results showed that the program did not have a positive effect on instant skin carotenoid score at post-test or maintenance for children across groups. Additional research can help establish protocols for collecting and interpreting Veggie Meter® data with Latino/a children [This study applied an inclusive approach to behavioral nutrition and targeted family functioning for Mexican-heritage families living in the Lower Rio Grande Valley of Texas. While the program was not a weight-centered program, there were promising results for BMI at post-test for Mexican-heritage children (six weeks after baseline or program start) and somewhat sustained effects on BMI at maintenance (three to four months after program completion). However, the children . Our finchildren ,69.


African Americans with type 2 diabetes experience disparities in their care and diabetes health-related outcomes. Diabetes self-management programs such as Healthy Living with Diabetes (HLWD) are important but do not account for the unique cultural experiences of African Americans. As well, a culturally tailored program focused on addressing sociocultural beliefs and providing race-congruent peer support, Peers LEAD  was implemented in two midwestern cities to improve medication adherence but does not include diabetes self-management topics included in HLWD. In attempt to fill the gaps from both HLWD and Peers LEAD, Peers EXCEL  was designed to integrate both programs.Our study explored the perceptions of African American participants and facilitators of the separate HLWD and Peers LEAD programs, on the proposed new Peers EXCEL program using focus groups and interviews. Findings were analyzed by research assistants trained in qualitative research using deductive and inductive open coding approaches.Participants described the lack of cultural fit of the current HLWD program for African American communities and proposed strategies to enhance Peers EXCEL’s impact in African American communities. They shared the need to include topics such as the relationships between systemic racism and diabetes.Participants’ feedback of Peers EXCEL reveals the importance of including various community member perspectives in the design of new diabetes self-management programs tailored for African Americans. African Americans are a historically marginalized population bearing substantial health disparities in the United States . CompareWe previously developed a peer-led intervention to specifically address health beliefs and increase medication adherence for improving diabetes-self management among African Americans, the Peers LEAD  program, which was found to be both feasible and acceptable by African Americans receiving peer support. In addition to providing one-on-one peer support, this intervention also includes group sessions addressing health beliefs and improving communication with healthcare providers. However, there are other important aspects of diabetes self-management, such as addressing diet and exercise, that were not included in the Peers LEAD program.To address gaps in these other aspects of diabetes self-management, we proposed to combine Peers LEAD with a well-established, community-based diabetes self-management program, Healthy Living with Diabetes (HLWD)  7). Whi. Whi7). Peers EXCEL is a novel diabetes self-management program that integrates the culturally tailored Peers LEAD program for African Americans with topics from HLWD, a community-based diabetes self-management program  while alWe recruited English-speaking adults 30-65 years of age with type 2 diabetes who self-identify as Black/African American and previously participated in either the Peers LEAD or HLWD programs. We used records of participants from these programs and personal contact by community partners to facilitate recruitment including word of mouth, phone calls, and emails. All participants provided verbal informed consent. All research activities were reviewed by the (University name) Institutional Review Boards (IRB) staff, which deemed the study exempt due to being interview and focus group research. The study was conducted in accordance with the Declaration of Helsinki.Interviews were conducted by the research team members, who were trained in conducting qualitative interviews by the Principal Investigator (P.I.) . The researchers conducted 30–45-minute semi-structured, individual interviews with Peers LEAD and HLWD participants. The interviews occurred via a secure web-based meeting platform  from September 2020 to December 2020. An interview guide was developed based on three domains of the Consolidated Framework for Implementation Research (CFIR): (1) intervention characteristics , (2) outer setting , and (3) inner settings . Interviewers provided participants with figures describing the topics and focus of the separate Peers LEAD and HLWD programs, and the integrated program, Peers EXCEL .Individual interviews were used because they are ideal for gathering in-depth views about a particular topic in a safe environment and allow researchers to delve deeply into delicate issues that participants may otherwise be uncomfortable sharing in a large group . The intWe conducted two separate focus group meetings with past Peers LEAD peer supporters, who lead the one-on-one peer support phone calls, and HLWD facilitators, who led group sessions for HLWD participants. Each 90-minute meeting was hosted via a secure web-based meeting platform  and the meetings were conducted from October 2020 to December 2020. The P.I. , an experienced focus group facilitator, an academic pharmacist, and a qualitative researcher, moderated the sessions. The focus group moderator was supported by research team members, who assisted with taking notes and managing the virtual platform. Focus group participants were provided with figures describing the topics and focus of the Peers LEAD, HLWD, and Peers EXCEL programs . Focus gResearch assistants trained in qualitative research  and pharmacy professional students: ) used deductive and inductive open coding approaches to conduct a directed content analysis  of the iTwo research teams were formed to analyze the focus groups  and interview  transcripts independently. The first cycle of analysis consisted of creating a coding framework. The frameworks were finalized through an iterative review process with feedback from the P.I. and . In the second analysis cycle, the analysis teams met independently to code and discussed their observations and findings. Differences in their findings were discussed among the analysis teams and shared with the entire research group until a consensus on data interpretation was reached. During the final analysis cycle, the analysis team met with O.S and M.M. to present findings and to fit codes from interviews and focus groups into higher-order categories. The interview and focus group data and coding methods were also reviewed by members of the (University Name) Institute for Clinical and Translational Research-Community Academic Partnership (ICTR-CAP) Qualitative Research Group. Data management was facilitated using NVivo software, Version 11.4.1 .Fourteen African Americans participated in the individual interviews and 19 African Americans participated in three separate focus groups to provide their perspectives on the combined Peers EXCEL program. The main themes were: (1) the lack of cultural fit of the HLWD program for African American communities, (2) proposed strategies to enhance Peers EXCEL’s impact in African American communities, and (3) important topics to cover in the Peers EXCEL program.Participants perceived a lack of cultural fit between the delivery of HLWD content by facilitators who are not African American/Black .Their concerns included the lack of African American facilitators, and that HLWD facilitators lacked experience in working with African Americans to deliver the program in a culturally sensitive manner.“I co-led [HLWD] with someone of another race [who is not Black]. And [HLWD participants] specifically requested for someone else that looked like me, basically, and looked like us, because majority of [HLWD participants] were Black…And [the non-Black HLWD co-facilitator], like they pulled me to the side after the meeting several times … would say things offensively, not necessarily intentional, but she just wasn’t, she didn’t have cultural humility.” – HLWD Facilitator #3The contents and methods used to deliver HLWD were also areas of significant concern for HLWD participants. Participants perceived that the language used in the written script could have been better suited for an African American audience. HLWD facilitators also perceived that they had to read the HLWD script and could not adapt their delivery style to engage their audience more effectively.“Just don’t see how anything from [the HLWD Program] is going to work [for Black participants] … I’m just saying, it was pretty much scripted, and you couldn’t veer off from the script … it’s hard to follow a script from Stanford [creators of HLWD] when you’re dealing with African Americans. That’s a whole, that’s like a different language.” – HLWD Participant #8Participants recommended that when introducing the Peers EXCEL program to African Americans, an emphasis should be placed on the importance of the program and to avoid the appearance of disparaging or “talking down” to program participants.“I think when [Black participants are introduced] to the [Peers EXCEL] program, it can’t be, ‘Well, we’re adding this because we know that, in the Black community, that you guys aren’t serious about taking your medication.’ It can’t be at a point of talking down to people …  we’re doing this because we want to emphasize the importance.” Peers LEAD Participant #4Participants described how the Peers EXCEL format of group-based discussions and one-on-one peer mentorship pairings empower African Americans to ask questions, receive advice from peers, and encourage building connections between community members.“And then when I joined this group, and I saw the fierceness of it and just listening to people talk about it, just really opened my eyes…I’m not afraid to ask questions now… So it opened me up to be a little more free to ask some questions from somebody else who gone through [living with diabetes] and to listen and get the advice from them.” – Peers LEAD Participant #6A prominent feature of Peers EXCEL for participants is how it recognizes the disproportionate prevalence of diabetes in African American communities.“I think the program is much needed, is important. Usually, illness that strike the community, it strikes the African community the worst. We need to begin to focus on our community because there’s a need. Period.” – Peers LEAD Participant #4Participants noted having opportunities to interact with a healthcare provider in Peers EXCEL could improve communication between African Americans and their healthcare providers.“I just think that just having real conversations with African Americans about how important it is to have a primary care doctor, just something that simple. I know my family, a lot of them didn’t even have a primary care doctor.” – Peers LEAD Participant #3Participants emphasized the importance of trust in African American communities and how having a physician and pharmacist that African Americans can trust is an important part of the program.“It seems like a couple things I think makes [Peers EXCEL] important, especially for the African American community…is trust. A lot of times, you’re not going to talk to your doctor or talk to individuals about things that are really causing you some issues, for whatever reason. And if you have an intimate connection with a doctor or a pharmacist or someone that you can trust to ask some of these questions, I think that would help as well with the community.” – Peers LEAD Participant #7Peers LEAD participants perceived that having group meetings and receiving one-on-one phone calls from their peers made the program personal, which was viewed as a strength.“The … program was very personal, one-on-one… But there’s something personal about working … one-on-one and knowing you’re going to get that [mentoring] phone call [from the Peers LEAD Ambassador] and then working with the entire group.” – Peers LEAD Participant #9Participants shared how the Peers LEAD one-to-one peers support format was unique and that they appreciated being partnered. According to participants, an added benefit of the Peers LEAD one-on-one peer support is that having a partner makes them accountable for achieving their goals as they manage their diabetes.“Peers LEAD was one-on-one. You actually had a one-on-one mentor. Very few are able to supply that. That one-on-one connection is nice.” – Peers LEAD Participant #8“I think that [one-on-one peer support] would help because it would encourage the person to continue on with the fight. So with someone checking in constantly, I think it would push and motivate you to do your goals or succeed with your goals.” HLWD Participant #2Participants described how HLWD content that focuses on goal setting would result in greater accountability regarding diabetes self-management when African Americans are provided with one-on-one peers support.“I think that it really would be beneficial because…with the Healthy Living with Diabetes, we set goals, and we have our different things that we want to accomplish. I think if it was one-on-one, I got to be accountable, if [my Peers LEAD Ambassador] is … going to ask me, ‘Well, did you take your medication this morning?’ and ‘What was your blood sugar?’… That one-on-one makes it more accountable. Even if I don’t feel like doing it, I’m going to do it. I think that combining the programs … you would be more accountable” – HLWD Facilitator #5In addition to recognizing the need for a program focusing on diabetes in African American communities, participants shared recommendations on how the research team can enhance Peers EXCEL’s impact on African American communities . These iParticipants perceived that for individuals to participate in Peers EXCEL, they will need to be highly motivated to join a program that requires a long-time commitment over several weeks, and includes diabetes-related topics they may have not fully explored, such as exercising and cooking. Our participants were concerned that Peers EXCEL may be more limited in its success if recruited individuals lack sufficient motivation.“That would be a long two-and-a-half hours to be working with [a participant] who don’t want to do better… especially when you start to … introduce exercise to individuals who haven’t exercised. You’re going to introduce new [ideas about] cooking to individuals who haven’t done [that type of] cooking. That may be a challenge, and I don’t want the program to fail because you don’t have certain individuals [who are at a sufficiently high] level of [motivation] to be a part of the program.” Peers LEAD Participant #5Participants added that, to engage motivated individuals in the program, the recruitment process must be designed to ensure that participants are motivated to improve their health and are not participating solely to seek monetary incentives.“I think the key is recruitment, and I remember [name of research team member] did an excellent job in… recruiting people and getting people. So the more thorough … the better … You [should try] to weed out the people who just want the cash and [are] not really [motivated].” Peers LEAD Participant #5Some participants recommended that the research team use monetary incentives for recruitment into the Peers EXCEL program such as using vouchers that could be used towards purchasing healthy food or by providing gym memberships to promote positive lifestyle changes.“Money is an incentive to get you there, which means once you get into that program, you might get motivated enough that you actually come out of there with something because it’s very informational if you’ve got diabetes. No telling, this program might just have turned somebody around…it might help save so many more.” – Peers LEAD Participant #6“I think an incentive would be great, especially if the incentive also goes to purchasing food. Like for them to be a part of this, you’re talking about healthy eating, then they actually have vouchers to get these foods…if you’re talking about exercise…Maybe incentive to get back to the gym safely, that they have like a membership for six months or three months, or something like that, to actually get into gym or something like that… Because we’re talking about a lifestyle change.” – Peers LEAD Participant #1Participants perceived that the recruitment process should be thorough in identifying individuals who are genuinely interested in improving their diabetes management and not only focused on the potential monetary incentives.“I think the key is recruitment, recruiting people and getting people… You can kind of start to weed out the people who just want the cash and not really concerned.” – Peers LEAD Participant #5Participants also shared how including interactive activities in Peers EXCEL could enhance trust and camaraderie within the Peers EXCEL program beyond discussing only diabetes-related topics.“… a social outing and gathering and still having fun, doing something other than doing the diabetes thing, some fun activities, as well…they went out to eat together and did things together and took trips together… They can trust one another with what they had to say about the struggle of diabetes. And it’s just that camaraderie that helps outside of the thought of we’re just here for diabetes.” – Peers LEAD Participant #3Recommendations for additional topics to be addressed in Peers EXCEL include addressing the mental health issues experienced by those living with diabetes, and the historical context and impact of systemic racism on African Americans’ experiences of living with diabetes .Some participants shared personal experiences growing up in segregated environments and how that impacted their ability to lead healthy lives while living with diabetes.“I know when we talked about the histories of some of our participants, we heard where they came from. Many of them came from segregated environments growing up… when they were younger, [they] would have been going the direction of leading a healthy life, but they had, of course, life issues that got in the way of eating…what’s considered to be a proper healthy diet.” – HLWD Facilitator #4Participants discussed how the topics of HLWD such as diet and exercise will help them in achieving personal goals related to their diabetes self-management such as losing weight.“I think the more active components of Healthy Living with Diabetes would kind of help me with the active parts. Also, the dietary parts of it could help me to lose the weight I’ve been trying to lose for a while… [These] would be useful tools.” HLWD Participant #3Participants perceived the importance of the topics addressed in Peers EXCEL, especially stress management, which has a substantial impact on their ability to manage their diabetes.“I think [these topics are] very important to know because you can get stressed out, and you can get overwhelmed and forget about your health, and next thing you know, it cause a problem because you’re not taking care of yourself … stress is a big part of being a diabetic, to me.” – Peers LEAD Participant #2Participants were interested in discussing ways to decrease medication costs, and how to read nutrition labels. Other topics include setting personalized goals, with group-based discussions concerning goal setting.I think if we could incorporate [goal setting] as a group instead of individuals, as [Peers LEAD] Ambassadors coming up with [those goals] … Speaking for my group, when we did talk about goals, some individuals didn’t think it was important to do. But [it might be more valued] if it’s a collective discussion and saying, part of the conversation is: we’re going to come up with goals.” – Peers LEAD Participant #7Study participants perceived that the Peers EXCEL program combined the benefits of Peers LEAD and HLWD into a culturally adapted program that could effectively help African Americans with diabetes achieve their diabetes self-management goals. These participants shared the need for culturally adapting the HLWD program, strategies to enhance the impact of the Peers EXCEL program in African American communities, and important topics to cover in the Peers EXCEL program. Our participants also highlighted the importance of providing social support and building a trusting environment when engaging with African Americans by designing culturally appropriate programs.A distinguishing feature of Peers EXCEL is the use of African American peer supporters and African American healthcare professionals to deliver the program. Culturally appropriate peer support programs engage members of the target community who understand the culture of the people, have an equal standing, have the same illness condition, and can connect with the group in a way acceptable to them . In addiWe also found that our participants valued having trusted healthcare providers share their expertise within the Peers EXCEL program and that relationships between systemic racism and diabetes should be discussed. Mistrust of the healthcare system stemming from historical and current racism faced by African Americans significantly contributes to diabetes-related healthcare disparities . MistrusIn addition to the need to cover critical topic areas, our study participants recognized that a novel intervention such as Peers EXCEL would need rigorous recruitment strategies. Participants recommended the use of incentives related to program goals. For example, vouchers to purchase foods that promote healthy eating and gym membership to promote exercise. Studies have shown that individuals with diabetes are willing to consider financial incentives to improve diabetes self-management . StudiesIn addition to its strengths, our study also had some limitations. While the CFIR framework was used to develop the focus group and interview guides, we found that participants’ responses did not adequately fit within the CFIR domains. Thus, we used an inductive approach to analyze the data. In addition, individuals who agreed to participate in interviews and focus groups may not represent all who participated in the Peers LEAD or HLWD programs.We conducted individual interviews and focus groups with African American stakeholders with prior experience in Peers LEAD and HLWD to further develop and refine the combined Peers EXCEL intervention. Interventions designed with the engagement of community members in a cultural context can improve health outcomes and potentially meet the unique needs of African Americans for diabetes self-management.


Correction to: The FIND Program: Improving Follow-Up of Incidental Imaging Findings 10.1007/s10278-023-00780-6There was a typographical error in the number of studies analyzed prior to and after implementation of the FIND Program quoted in the Materials & Methods and Results sections.The first sentence of the second paragraph of the Materials & Methods section should read: “Electronic medical records and final reports of a total of 2000 randomly selected patients were investigated. A total of 1000 patients with 1274 studies from January 2019 to January 2020 prior to implementation of the FIND Program and 1000 patients with 1228 studies from September 2020 to September 2021, 1 year after implementation of the FIND Program were analyzed.”The first sentence of the first paragraph of the Results section should read: “A total of 1274 studies were performed on 1000 patients from January 2019 to January 2020 prior to implementation of the FIND Program at Trinity Health Oakland Hospital, and 1228 studies were performed on 1000 patients from September 2020 to September 2021, 1 year after implementation of the FIND Program.”There was a typographical error in the number and percentage of completed recommended follow-up imaging in the pre-implementation group in Table The original article has been corrected.


The aim of this study was to evaluate the effectiveness of a real-life clinical physical activity program (DIAfit) on improving physical fitness, body composition, and cardiometabolic health in an unselected population with type 2 diabetes mellitus, and to compare the effects of two variants a different exercise frequencies on the same outcomes.1c, muscle strength, walking speed, balance, flexibility, blood pressure, lipid profile.This was a cluster randomized-controlled assessor-blind trial conducted in 11 clinical centres in Switzerland. All participants in the clinical program with type 2 diabetes were eligible and were randomized to either standard (3 sessions/week for 12 weeks) or alternative  physical activity program each consisting of 36 sessions of combined aerobic and resistance exercise. Allocation was concealed by a central office unrelated to the study. The primary outcome was aerobic fitness. Secondary outcome measures included: body composition, BMI, HbAAll 185 patients with type 2 diabetes  agreed to participate and were randomized in two groups: a standard group (n=88) and an alternative group (n=97)). There was an 11% increase in aerobic fitness after the program . Significant improvements in physical fitness, body composition, and cardiometabolic parameters were observed at the end of the DIAfit program (improvements between 2-29%) except for lean body mass, triglycerides and cholesterol. No differences were observed between both programs, except for a larger weight reduction of -0.97kg  in the standard program.1c, body composition, and blood pressure in type 2 diabetes patients and differences were negligible.Both frequency variants of the nation-wide DIAfit program had beneficial effects on physical fitness, HbAclinicaltrials.gov, identifier NCT01289587. Physica.8% and i1c or physical fitness measures , as well as on strength, flexibility, balance and walking speed, anthropometry, body composition and cardiometabolic parameters independent of the selected frequency variant of the program. Secondly, we compared the effectiveness of the standard DIAfit program (3x/week over 12 weeks) with an alternative program including the same total sessions but differed in frequency (increasing frequency from 1x/week up to 2x/week over 20 weeks) on the same outcomes.22.1www.diafit.ch). Recruitment took place between September 2010 and December 2011. It was simultaneously introduced in 2011 in 11 diverse treatment centres in the French-speaking part of Switzerland. The basic health insurance approved the reimbursement of the program under the following criteria: presence of an adapted infrastructure, the ability to provide CPR, a diabetologist that had undergone a one-day training and a physical therapist/sport scientist that had undergone a 2-week training. To ensure quality of delivery, each centre had to provide an entry and exit medical visit, offer 36 supervised exercise sessions that included both resistance and endurance activities and ideally also balance and flexibility training as well as 6-8 educational group sessions about diabetes and lifestyle. Eligibility criteria for the treatment centres to participate in the study was defined by the ability to offer the clinical program. All 11 centres eligible to participate in the clinical program underwent simultaneous training and agreed to participate in the study and none of the centres dropped out during the study. Centres included 7 small regional hospitals or medical centres, 2 private practices and 2 tertiary university hospitals. All 11 centres had to fulfil the following conditions: to provide a trained a responsible physician that oversees the program and carries the medical responsibilities, a qualified physical therapist, a qualified diabetologist who is also member of the Swiss Society of Endocrinology and Diabetes who has a consultant role, and a qualified dietician.The clinical DIAfit program is a nationwide Swiss lifestyle based real-life clinical group intervention program  to randomly start one program variant first and then the other using concealed opaque envelopes. Each centre thus provided both variants. Selection and randomization took place 2 weeks before the start of each program and were performed by a central coordinator (OG) who was not involved in the study. Patients signed informed consent before knowing their group allocation. Health care providers and investigators were blinded to group allocation before the start of the first program. The primary outcome assessors were always blinded to the respective variant. Patients and the clinical staff such as the physical therapists could not be blinded since they knew how many sessions per week were attended. Both program variants were matched by number of sessions  but diff2.3The study was approved by the ethical committee of Lausanne in 2011 (protocol 252/10) and all participants signed a written informed consent. The trial was registered .2.41c, lower limb muscle strength, walking speed, balance, flexibility, BP, and lipids. Cardiometabolic parameters were measured during the initial medical visit. Physical fitness and body composition measures were assessed directly in the clinics.All primary and secondary outcomes were reported at the level of the individual. Specially trained researchers and clinicians measured all outcomes. The primary outcome was the change in aerobic fitness. Secondary outcomes included changes in body composition, BMI, HbA2.4.1Physical fitness was assessed by five parameters: aerobic fitness, lower limb muscle strength, walking speed, balance, and flexibility.Aerobic fitness was evaluated with a maximal graded cycle ergometry test performed by a cardiologist blinded to the other data. Participants started at 20 Watts. Increments of 20 Watts per 2 min were made until exhaustion or until reaching one of the American College of Sports Medicine established criteria for maximal oxygen uptake . Heart rLower limb muscle strength was assessed with the Chair Stand Test. Participants sat with arms folded across the chest and with their back against the chair. The patient was instructed to stand up and sit down five times as quickly as possible and the required time (sec) was recorded . Walking2.4.2® .During the medical visits, body weight and height were measure barefoot and clothes off. BMI was calculated based on measured height and weight. Waist circumference was measured midway between the iliac crest and the lowest border of the rib cage. Body composition was assessed by bioelectrical impedance using a 4-polar single frequency device . The fat and lean body mass were predicted using the software Bodygram2.4.31c and fasting lipid values at the beginning and the end of each program in their local laboratory. HbA1c was measured using high-performance liquid chromatography (HPLC), which is IFCC  standardized  was included as a covariate since it’s related to physical fitness in patients with type 2 diabetes . Educati2.5Statistical analyses were conducted using STATA 16 . Taking into account a drop-out of 1 centre with an average program size of 10 patients per centre, we assumed that 7 patients per centre would participate in both aerobic fitness tests . In case of sickness on the testing day, the stress test (aerobic fitness test) will be repeated on another day. A total number of 10 centres (70 patients per treatment arm) would then provide enough power to detect a true intervention effect of two-thirds of an inter-subject standard deviation at the usual significance level of 0.05 with a probability of 0.8, provided that the standard deviation of the random class effect does not exceed 3% of the inter-subject standard deviation . Therefore, we included 11 treatment centres.P values for superiority. Student’s t-test for paired samples was used to examine the effectiveness of the DIAfit program on primary and secondary outcomes between baseline and the end of the program. For the primary outcome, 162 patients were analysed and according to the specific outcome measure, 154 to 179 patients were analysed, see Complete-case analyses were performed according to intention to treat. Descriptive statistics were calculated using mean ± SD for continuous variables, or percentage for categorical variables. The analyses of the primary and secondary outcomes were based on a superiority assumption and presented as mean differences with 95% CI and 1c, lower limb muscle strength, balance, flexibility, diastolic BP, LDL, total cholesterol and triglycerides. The predictors were the study arm (=program variant), age, sex, and educational level.Linear regression analyses were performed to test the difference in outcome at the end of the program between both arms. In the regression models, the dependent variable was represented by baseline to end-of-study change in HbAIn case of significant association between change in outcome and the centre, mixed model analyses were performed. This was the case for aerobic fitness, walking speed, body weight, BMI, lean body mass, fat body mass, HDL, systolic BP. In the mixed models, the centre was the unit of randomization and change in physical fitness, body composition, and cardiometabolic health outcomes as the dependent variables. The predictors were the study arm, age, sex, and educational level. The objective was to check for each outcome if the coefficient related to the program type is significantly different from 0. Statistical level was set at P<0.05 for all analyses.To account for missing values, in a secondary analysis all cases were included in the analysis by using multivariate imputation by chained equation (MICE), with the assumption that the data are missing at random . Results3Baseline characteristics of the study participants are reported in 3.1Compared to baseline, aerobic fitness increased by 12.5 Watts . This corresponds to a mean improvement of 11%. Also, at the end of the program participants needed 2.95sec  less for the lower limb strength test (=increased strength), increased their flexibility by 3.45cm , could stand on one leg for 1.94sec  longer, and needed 1.27sec  less for the 10m walking speed test. In summary, there was a mean improvement of 10-29% in the secondary physical fitness outcomes.3.22  and waist circumference decreased by 1.14cm . Body fat mass decreased by 1.32kg  between baseline and the end of the program, while there was no difference in lean body mass.Body weight decreased by 0.93kg , BMI decreased by 0.34 kg/m3.31c decreased by 0.19%  and systolic and diastolic BP decreased by 3 mmHg  and 3 mmHg , respectively. There were no effects on triglycerides and cholesterol levels (p>0.11).Between baseline and the end of the program, HbAExcept for body weight, there were no significant differences in all outcomes between the standard and the alternative programs (p>0.05). The difference favoured the standard group, with a more pronounced weight reduction of -0.94kg . For weight metrics, the effects remained the same after adjusting for weight status at baseline (data not shown) when comparing both intervention programs.Throughout the 36 sessions, the average exercise training attendance was 30.6 sessions (85%) for the standard program and 28.9 sessions (80%) for the alterative program .41c, and BP. Our results also showed that both a standard “classical” approach to exercise frequency as well as an alternative “feasible” approach led to similarly improved health outcomes with an additional benefit of the standard program on weight reduction.This pragmatic randomized trial demonstrated the effectiveness of a real-life nationwide PA group program (DIAfit) in improving aerobic fitness and other physical fitness outcomes such as strength, flexibility, balance and walking speed by 10-29%. Although to a lesser extent, the program also improved body weight, body composition, HbAThis study showed important findings regarding translating evidence from highly specialized research centres into real-life clinical practice. Indeed, all patients enrolled in the clinical DIAfit program were eligible and agreed to participate in the study. The program took mostly place in small regional hospitals, but also in private practices or university hospitals. The DIAfit program was delivered by regular staff with no specific experience. All of which increased the generalizability of our findings. Furthermore, patients in our study were of similar age or older than those in previous studies. They had a mean baseline HbA1c of 7.3% which is representative of the glycaemic control observed in larger community-based cohorts of patients with diabetes in Switzerland . There w2max after intervention  (The DIAfit program was associated with a reduction of a 0.19% in HbAs (0.5%) . These ds (0.5%) , 16, 34.s (0.5%) .The DIAfit program was effective in improving body composition. The observed mean reduction in weight of 0.93 kg and waist circumference of 1.14 cm are similar to results found in some structured PA programs of similar duration without any dietary intervention and demonstrates the effects that can be achieved with this intensity and volume of PA , 9, 13. 1c and blood pressure, and in some circumstances the changes were only significant in the standard program. However, significant difference between both programs were only found for weight and BMI with a more marked weight reduction in the standard program. Reasons for differences in weight reduction could lie in a more short-lasting willpower regarding concomitant changes in nutrition or in overcompensating hypoglycaemia. Physical activity attendance did not differ between the standard and the alternative program. The current results demonstrate that the alternative “feasible” approach is not necessarily more feasible for all patients, and the standard “physiological” approach showed some benefits regarding weight. Based on these results, for patients who have no preferences at all, we would suggest the standard program. However, according to patient preferences, both type of programs could represent an almost equally effective and feasible strategies for improving health in patients with type 2 diabetes. Our results based on real-life observation provide evidence regarding the possible flexibility when designing future exercise programs for this population. To achieve therapeutic goals in type 2 diabetes patients, it is important to consider optimal type, frequency and duration of exercise when designing PA programs to meet the specific needs of each individual. To our knowledge, effects of different exercise frequencies on multiple health outcomes have not been compared so far. Previous intervention studies in patients with type 2 diabetes conducted in specialized centres using two sessions per week demonstrated improvements similar to our study in aerobic fitness, muscular strength, and body composition after 4-12 months intervention (1c (0.10-0.45%) compared to our findings (1c, BP, body weight after intervention (In this study, we also compared two program variants and found similar results for physical fitness, body composition, and cardiometabolic parameters in both programs although effect sizes of changes were larger in the standard program regarding anthropometric parameters, body fat mass, HbArvention , 18, 20.findings , 18, 19.rvention , 20. TheStrengths of the current study included the pragmatic nature of a nation-wide PA program which demonstrated the benefits and relevance of structured PA for patients with type 2 diabetes in real-world conditions integrated in routine care. The multicentre design in different settings increased the external validity since the results were observed in different clinical settings. Furthermore, we included a broad range of outcome measures including extensive physical fitness measures relevant for various health outcomes such aerobic fitness, muscular strength, flexibility, balance, and walking speed. And lastly, the comparison of different forms of exercise frequency is not only novel, but also pertinent for clinical practice. Some limitations should be noted. The most important one being the lack of a control group for our first aim. However, participating health care providers and cantonal agencies did not approve the idea of a waiting list which would not let benefit all patients at the time when they are motivated or at least agree to participate in a PA program. All providers were told not to adapt the medical treatment during the testing time period, but we did not control for any potential changes in medication intake. In this real-life trial, small differences between centres were observed in several outcomes such as aerobic fitness, walking speed, anthropometry, body composition, and some cardiometabolic parameters, see 5The national DIAfit PA group program was effective and deliverable in real-world clinical settings for promoting PA and improving important health parameters such as physical fitness, cardiometabolic health, and body composition in patients with type 2 diabetes. The alternative program of one-to-twice weekly supervised combined aerobic and resistance exercise had similar benefits compared to the classical program and can serve as a useful example for implementing a site-tailored PA intervention.Part of the original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding author.The studies involving human participants were reviewed and approved by Lausanne University Hospitals Ethical Committee. The patients/participants provided their written informed consent to participate in this study.JP and OG with the assitance of HD, MC, DD, SB and DS were responsable for the study design and all authors helped data collection. J-BR, AA and JP were responsible for the statistical analysis and AA and NJ helped with data management. AA and JP wrote the manuscript draft. All authors contributed to the article ad approved the submitted version.


Autism spectrum disorder (ASD) encompasses a heterogeneous group with varied phenotypes and etiologies. Identifying pathogenic subgroups could facilitate targeted treatments. One promising avenue is investigating energy metabolism, as mitochondrial dysfunction has been implicated in a subgroup of ASD. Lactate, an indicator of energy metabolic anomalies, may serve as a potential biomarker for this subgroup. This study aimed to examine cerebral lactate (Lac+) levels in high-functioning adults with ASD, hypothesizing elevated mean Lac+ concentrations in contrast to neurotypical controls (NTCs).Magnetic resonance spectroscopy (MRS) was used to study cerebral Lac+ in 71 adults with ASD and NTC, focusing on the posterior cingulate cortex (PCC). After quality control, 64 ASD and 58 NTC participants remained. Lac+ levels two standard deviations above the mean of the control group were considered elevated.p = 0.028; Cohen’s d = 0.404), and 9.4% of the ASD group had elevated levels as compared to 0% of the NTCs (p = 0.029). No significant correlation was found between blood serum lactate levels and MRS-derived Lac+ levels.Mean PCC Lac+ levels were significantly higher in the ASD group than in the NTC group  and moderate increase require further investigation to elucidate the underlying mechanisms and relationships with mitochondrial function.The online version contains supplementary material available at 10.1186/s13229-023-00577-y. Autism spectrum disorders (ASDs) encompass a wide range of phenotypic expressions and are rooted in complex etiologies involving an interplay of environmental and genetic factors –4. DiagnLactate is produced during anaerobic metabolism and serves as a critical metabolic intermediary in several organs, particularly the brain, where it is thought to facilitate energy transfer between astrocytes and neurons , 13. EleMD can result from factors such as genetic variation , oxidatiThe link between energy metabolism and ASD was first described by Coleman and Blass in 1985 . They id1H-MRS). Most previous 1H-MRS investigations in ASD have focused primarily on metabolites other than lactate, specifically glutamate [Compared to research on peripheral lactate levels in ASD, there is a limited number of studies investigating brain lactate concentrations using proton magnetic resonance spectroscopy . Participants gave written informed consent.Participants with ASD, including Asperger’s Syndrome as defined by the Diagnostic and Statistical Manual of Mental Disorders  and International Classification of Diseases , respectively, were enrolled, excluding those with known secondary genetic forms of ASD. The diagnoses were established by experienced senior psychiatrists with expertise in ASD according to the ICD-10 (F84.5) as well as DSM-5 criteria (299.0). In addition, the following questionnaires were administered: Autism Spectrum Quotient (AQ) , EmpathyParticipants underwent a battery of diagnostic tests, including the Structured Clinical Interview (SCID I and II) , 52, Aut2), neurological disorders such as seizures, and regular benzodiazepine use. Treated hypothyroidism did not result in study exclusion. For ASD participants, bipolar disorder, psychotic symptoms, and substance abuse were additional exclusion criteria. The NTC group consisted of participants without psychiatric disorders as assessed by the SCID, SCL-90-R, SRS-2, and WURS-k.Exclusion criteria included MRI contraindications , metabolic conditions , obesity  for MRS planning and tissue segmentation.Magnetic resonance imaging data were acquired at the Radiology Department of the University Medical Center Freiburg, Germany, using a Magnetom Prisma 3 T system  with a 20-channel head coil. A T1-weighted magnetization prepared rapid gradient echo (MPRAGE) protocol provided an anatomical 3D dataset  were positioned over the splenium, specifically near the tentorium cerebelli in the occipital region of the CC to maximize the signal-to-noise ratio and capture the PCC while minimizing cerebrospinal fluid inclusion , mI (myo-inositol), Lac (lactate), NAA (N-acetylaspartate), NAAG (N-acetylaspartylglutamate), PCh (phosphocholine), PE (phosphoethanolamine), sI (scyllo-inositol), Tau (taurine), Thr (threonine). In the lactate-edited difference spectrum, we added two Gaussian components (MM12 and MM14) to account for co-edited macromolecular (MM) signals, as described in our previous investigation of the acquisition technique [Data analysis was performed using Osprey (v2.5.0) , an openechnique . A splinAs lactate and threonine have resonances at similar spectral frequencies (~ 1.31 ppm), their signals strongly overlap, complicating distinct identification. Due to this overlap, our primary outcome was the sum of lactate and Thr, referred to as Lac+.We initially used the Shapiro–Wilk test to verify the normal distribution of five Lac+ estimates from Osprey. These were: (1) the unadjusted Lac+ metabolite amplitude; (2) the raw water-scaled Lac+ concentration, i.e., the Lac+ metabolite concentration divided by the water amplitude; (3) the water-scaled and CSF-corrected Lac+  concentration; (4) the water-scaled, CSF-corrected, and tissue-relaxations-corrected Lac+ concentration; and (5) the Lac+/tCR ratio. The data were normally distributed for all estimates and for both groups (ASD and NTC).Informed by theories such as the lactate-shuffle theory, suggesting differences in lactate concentrations across gray matter (GM), white matter (WM), and cerebrospinal fluid (CSF), we conducted an empirical investigation. The aim was to determine which of the five lactate estimates  best minimized these fractional volume effect. Since non-collinearity of independent variables is a fundamental assumption in ANCOVA models, we addressed the inherent collinearity between the voxels’ fractional GM, WM, and CSF volumes. Refer to Additional file Our next goal was to identify demographic and MRS quality-related covariates that might significantly impact Lac+ concentrations.  [Assessment of serum lactate levels revealed a non-normal distribution as determined by the Shapiro–Wilk test. To address this, we employed a Tukey’s Ladder of Powers transformation to mitigate data skewness. While this transformation did lessen the skewness, the distribution remained significantly non-normal according to a subsequent Shapiro–Wilk test. Consequently, we utilized robust Yuen’s independent samples package) , 75 to ppackage) .To explore the relationship between Lac+ concentrations and psychometric scores  and participants’ age, we computed Spearman’s correlation coefficients for both groups and the ASD group specifically. Additionally, we computed correlation coefficients of the fractional GM, WM, and CSF volumes  with the psychiatric scores and age. Adjustments for multiple comparisons were not made at this stage as our focus was on exploring data relationships, not confirmatory claims. These correlations were visualized using a correlation matrix in R's corrplot package.We also examined the link between brain Lac+ concentrations in the PCC and serum lactate levels using Spearman’s correlation coefficients for both the combined and ASD groups.To assess the influence of medication on PCC Lac+ concentrations, we used an ANCOVA model with Lac+ concentrations as the dependent variable, group as the independent variable, and a variety of medications as separate covariates. The medications considered included antipsychotics, atypical antipsychotics, serotonin–norepinephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs), other antidepressants, lithium, stimulants, anticonvulsants (lamotrigine), benzodiazepines (“standby medication”), and oral contraceptives.To account for potential variations in lactate levels due to time of day, we ran two separate models: In a four-time-period model, we divided the day into four periods: morning (7–10 am), noon (11 am–1 pm), afternoon (2–4 pm), and evening (5–8 pm). An ANCOVA model was run with Lac+ concentrations as the dependent variable, group as the independent variable, and time of day categorization as a covariate. In a two-time-period model, we performed the same ANCOVA analysis but divided the day into two parts: before noon (7:00 am–12:00 pm) and after noon (1:00 pm–8:00 pm).In addition, we measured one of the authors on 2 days in the morning and evening. Details are provided in Additional file The two groups did not show significant differences in age, gender, and IQ, as shown in Table t(119.25) = 2.23, p = 0.028, Cohen’s d = 0.404; cf. Fig. t test remained significant (t(117) = 2.08, p = 0.0399, Cohen’s d = 0.380). No significant group effect was found in exploratory analyses of total NAA (tNAA = NAA + NAAG)  = 1.546, p = 0.216) and log-transformed tCr  = 0.056, p = 0.813). Detailed information on additional lactate estimates and exploratory analyses of tNAA and log-transformed tCr concentrations can be found in Additional file There was a significant difference in Lac + concentrations between the ASD and NTC groups, as shown by the two-sample t test analysis , with all six ASD individuals having Lac+ concentrations between two and three standard deviations above the mean for the NTC group.Using a reference range based on the control group—where the upper limit of normal Lac+ concentrations was defined as two standard deviations above the mean—we identified six individuals within the ASD group who had elevated Lac + concentrations (9.4%), compared to none in the NTC group. This difference in the frequency of elevated Lac+ concentrations was significant (t(NA) = -2.25, p value = 0.029).Group comparisons of blood serum lactate levels in the current sample—a subset derived from a previously published larger sample —revealedIn the correlation analyses performed for the ASD group and for both groups combined, no significant correlation was found between Lac+ concentrations and psychometric scores or age of the participants cf. Fig. . Only frR = − 0.04, p = 0.792). Details of the group differences in serum lactate levels between the ASD and NTC groups  are reported elsewhere [Our analysis indicated no significant correlation between serum lactate and Lac+ concentrations in the PCC for either the ASD group or the combined groups cf. Fig. . We rerulsewhere .Fig. 4ScF = 4.556; p = 0.035). Of the medications considered, only anticonvulsants showed a significant effect on Lac+ concentrations  = 4.921; p = 0.029). It is important to note that this effect was attributed to only one individual with ASD who was taking anticonvulsants (lamotrigine) as an off-label medication.Analysis with an ANCOVA model including all medications as covariates showed that the group effect identified in the t test remained significant  = 5.186; p = 0.025) and no significant effect for day time  = 0.344; p = 0.794). The two-time-period model also showed a significant group effect  = 5.198; p = 0.024) but no significant effect for day time  = 0.506; p = 0.478).Analyses with the ANCOVA models of the four-time-period model showed a significant group effect  from the ASD group had elevated Lac+ levels (none from the NTC group), lower than the originally hypothesized 20%. There was no significant correlation between blood serum lactate levels and MRS-derived Lac+ levels in the PCC, and those with elevated cerebral Lac+ in the ASD group had normal serum lactate levels. In addition, there was no significant correlation between Lac+ concentrations and psychometric scores, including autism and ADHD symptom severity, depression, and IQ.The finding of elevated cerebral Lac+ in the PCC is consistent with previous research by Goh et al. , who obsThe question remains whether, for a subset of individuals with ASD, mitochondrial dysfunction could be a potential pathomechanistic marker. In our study of high-functioning adults with ASD, there was no evidence of mitochondrial dysfunction based on blood analysis of energy metabolism markers and cerebral lactate concentrations . It is iIn our study, we found no between-group differences in tNAA and tCR, which is in contrast to some pediatric ASD studies that have reported lower NAA levels , 77. SinWhile elevated lactate is typically associated with mitochondrial dysfunction, other factors such as stress, , physicaIn summary, previous MRS studies have generally reported no increase, a smaller increase, or a smaller proportion of individuals with ASD with elevated cerebral lactate levels , 40, 41 This study highlights the importance of a comprehensive approach to screening for energy metabolism abnormalities such as elevated lactate levels in multiple compartments and tissues, including blood serum, cerebrospinal fluid, and brain. The study by Goh et al.  suggestsFuture research could use MRS techniques with high sensitivity to quantify lactate across various brain regions and might monitor lactate concentration changes in response to stimulus-induced brain activity , 96. In p value of 0.028, we acknowledge that there is ongoing debate regarding the traditional threshold for statistical significance of p < 0.05, with some recent suggestions advocating for a more stringent threshold of p < 0.005. Given this context, our findings should be interpreted cautiously and replicated in further studies to confirm their robustness.Although our main result reached statistical significance with a We also acknowledge that intra-individual variation in lactate levels, which may be influenced by various factors such as time of day, physical status, carbon-rich diet, and exercise load, is a limitation of our study and warrants careful consideration in future research. Although participants were asked to refrain from physical activity the day before data collection and we did not find a significant effect of time of day in our statistical models, longer-term effects, diurnal and dietary effects cannot be ruled out.While medication does not appear to be the main factor in the increased Lac+ levels observed in the ASD group, other non-mitochondrial factors may be contributing. In particular, the ASD group had significantly higher anxiety levels before entering the scanner, and although there were no clear signs of hyperventilation or panic, increased muscle tension due to anxiety could cause a slight increase in Lac+. However, we did not find a significant correlation between Lac+ signals and anxiety scores. Future studies may benefit from including additional measures of respiratory status, such as capnometry. In addition, our study had to exclude several participants due to severe artifacts in the MR spectra, possibly caused by head motion. Future research could monitor head motion during the MRI scan or even correct it prospectively . AlternaElevated lactate levels may suggest mitochondrial dysfunction in some individuals with ASD. It is possible that a mild form of mitochondrial dysfunction, localized to specific areas, could cause the elevated cerebral lactate levels. Future research should thoroughly investigate the causes of these elevated lactate levels, explore whether they are related to mitochondrial dysfunction, and try to understand their distribution in different areas and tissues. It is also crucial to investigate whether these lactate elevations in ASD are due to specific causes, such as mitochondrial DNA mutations .Additional file 1. Supplementary information, tables and figure.