The Healthy Lifestyle Program for women (HeLP-her) is a low-intensity, self-management program which has demonstrated efficacy in preventing excess weight gain in women. However, little is known about the implementation, reach, and sustainability of low-intensity prevention programs in rural settings, where risk for obesity in women is higher than urban settings. We aimed to evaluate a low-intensity healthy lifestyle program delivered to women in a rural setting to inform development of effective community prevention programs.A mixed method hybrid implementation and evaluation study, guided by the RE-AIM framework , was undertaken. Data collection tools included anthropometric measures, program checklists, questionnaires, and semi-structured interviews with participants and local stakeholders. The RE-AIM self-audit tool was applied to assess evaluation rigor.2 (±SD 6.9). A between-group weight difference of −0.92 kg (95% CI −1.67 to −0.16) showed program effectiveness. Reach was broad across 41 towns with 62% of participants reporting influencing some of the health behaviors of their families. Strong implementation fidelity was achieved with good retention rates at 1 year (76%) and high participant satisfaction (82% of participants willing to recommend this program). Over 300 multi-level community partnerships were established supporting high adoption. Stakeholders reported potential capacity to implement and sustain the prevention program in resource poor rural settings, due to the low-intensity design and minimal resources required.Six hundred and forty-nine women from 41 relatively socio-economic disadvantaged communities in Australia participated: mean age 39.6 years (±SD 6.7) and body mass index of 28.8 kg/mOur comprehensive RE-AIM evaluation demonstrates that an evidence-based obesity prevention program can be successfully implemented in real-world settings. The program achieved broad reach, effectiveness, and satisfaction at the community and stakeholder level, revealing potential for program sustainability. The evaluation addressed implementation knowledge gaps to support future obesity prevention program scale-up.12612000115831 [http://www.anzctr.org.au/].Australian and New Zealand Clinical Trial Registry ACTRN The online version of this article (doi:10.1186/s13012-016-0521-4) contains supplementary material, which is available to authorized users. Treatment of established obesity via lifestyle interventions is challenging with poor engagement, high costs, and minimal sustainability , 2. WeigGovernment prevention agencies have advocated the need for weight gain prevention programs in high-risk populations. Women have high rates of unhealthy weight gain , 8, and In developed countries, rural-dwelling women are more vulnerable than urban-dwelling women with lower socio-economic status and elevated rates of weight gain and obesity , 21. AddEvaluation provides vital insights into how a program achieves efficacy and effectiveness. It also generates essential knowledge to drive implementation and scale-up –27 and dThe RE-AIM evaluation framework  explores program implementation and generalizability, focusing on the transferability of research findings into clinical practice and policy. The RE-AIM framework was developed specifically to evaluate health promotion interventions and encourages data collection at both the individual and organizational level , 37. TheThe Healthy Lifestyle Program (HeLP-her) is an evidence-based weight gain prevention program for reproductive-aged women, which here was adapted for rural settings in the HeLP-her Rural trial, with an embedded hybrid implementation and evaluation design . This maThe efficacy of the HeLP-her program has been established previously in two large RCT’s in a community setting for urban-dwelling women and in an antenatal clinic setting for pregnant women , 17. HerIn summary, the program involved a 1-year active intervention followed by a 1-year observation phase (yet to report). Control participants received a single general group health information session. The intervention aimed to improve participant’s self-management capacity through skill development including goal setting, problem solving, and relapse prevention underpinned by the self-determination theory  and motiThis manuscript reports on the results of the embedded program evaluation using an effectiveness-implementation hybrid study design and involved the simultaneous testing of clinical outcomes and implementation strategies. This research design is thought to facilitate “more rapid translational gains, more effective implementation strategies and promote the collection of useful information for decision makers for scale-up” . This stRecruitment occurred from September 2012–April 2013  measuring Socio-Economic Indexes for Areas (SEIFA) of relative disadvantage was utilized . PotentiProgram checklists and log booksProgram specific process evaluation checklists were developed in conjunction with the research team field notes to assess implementation fidelity, recruitment, dose delivered, and program context. Program log books were kept to monitor program communication with organizational program partners.Observations by the research teamThe intervention was delivered by a research team (dieticians and exercise physiologists), working in pairs, with one researcher delivering the intervention, the other observing implementation, collecting data, completing checklists and offering feedback to ensure delivery consistency. Program fidelity was addressed by all researchers undergoing a 1-day training workshop (August 2012) delivered by an experienced trainer (CB) and receiving ongoing support and utilizing program developed presentations and resources, promoting consistency of program delivery , and 24 months (end of observation).Questionnaires completed by participantsAll participants completed program devised questionnaires at baseline (prior to intervention commencement) and 12 and 24 months including items on demographic characteristics, socio-cultural and physical environment, health status, and program satisfaction. Participant program satisfaction  was assessed on a program-devised Likert scale (1–5) with higher scores representing greater satisfaction.Semi-structured  participant and stakeholder interviewsIn-depth semi-structured interviews were conducted with a sub-group of participant’s 6 months post intervention commencement. A criteria-based, convenience sampling approach as previously described , 48 invoLocal stakeholders were identified as those who had a direct interest in the development, delivery, and outcomes of prevention programs and included local government employees, clinical health care providers , and non-clinical health providers as previously described . These sEvaluation self-audit  of the HeLP-her Rural programn = 31) producing total and item-specific scores for each of the five RE-AIM domains. This corresponds to a comprehensive application of the framework, termed “fully developed use of RE-AIM”. Items that are not applicable to the program were excluded from the total calculated score  The HeLP-her Rural evaluation used mixed method data collection design .Results are presented in accordance with the RE-AIM dimension and associated key evaluation questions informed by previous literature , 37, 40.n = 649 women were recruited, representing ~10% of the eligible target population Qualitative participant interviews highlighted that the HeLP-her Rural program prevention messages reached beyond participants to their families and households. Of the intervention participants interviewed, all reported influencing the health behaviors of their household to various degrees such as increasing water, fruit, and vegetables consumption and physical activity frequency and limiting high-fat snack foods and takeaways.(My husband) he’s my resistance band. He’s like, no, you can have Coke, you can have pies. It’s very hard (for me)- [control participant]I’ve got two kids that are very fussy eaters…At the end of the day I can’t be bothered with the arguments and whinging - [control participant]Participants unable to influence their household health choices described barriers which primarily related to unsupportive or resistant family members.My weight is something I’m very embarrassed about so I tend not to discuss it with friends. I don’t suppose my friends are struggling with it as I am - [control participant]In contrast, women were less likely to influence the health behaviors of their social networks, citing personal and social reasons. Personal reasons related to feelings of “embarrassment,” wanting to maintain “privacy,” and “low confidence”.Social barriers to broader program reach included lack of socially acceptability to talk to friends about their weight and lifestyle choices as they do not want to be perceived as “self-absorbed” and “talking about myself all the time.” Other participants described that as many of their friends were already “very active” and “pretty healthy,” there was no need to discuss program learnings. Social isolation was another commonly described reason for not influencing social networks. Others noted beliefs that their friends were “unsupportive” and disinterested, “none of my friends are really into exercise and healthy lifestyles”.n = 230) and control participants (n = 207) at 12 months showed that 62% of the participants reported influencing health behaviors of their families. However, there was no statistical significant difference between groups. The participants were most likely to influence their children (38%), friends (34%), and partners (30%).Consistent with our qualitative findings, quantitative questionnaire data collected from intervention  and the intervention group at −0.48 kg (95% CI −0.99 to 0.03), with a between-group difference of −0.92 kg (95% CI −1.67 to −0.16) or −0.88 kg (95% CI −1.62 to −0.13) adjusted for baseline values and clustering .Behavior change continuation was facilitated by participant’s ability to apply the core program messages such as setting achievable behavior change goals, problem solving, and relapse prevention. Improved health knowledge, internal motivation, self-efficacy, and internal accountability all supported continued behavior change as previously described .We partnered with more than 300 local organizations across the 41 rural communities with at least three partners from various community sectors in each community. Our partnering success rate was 95% amongst local stakeholders  sounded like something worth promoting. That low commitment program… It sounded like a good program to support – [Health Service Manager].Stakeholders partnered with the HeLP-her Rural program team due to the underlying robust theory, evidence base, and simplistic low-intensity design.In addition, many stakeholders valued the use of remote methods to deliver lifestyle advice, “It’s new, innovative ideas and I think that using digital medium is a great way.”I think we could probably deliver a program like that ourselves, with the correct information, I mean and tailoring it to what we’ve got. Actually I was sitting in on the program and thinking you know we could do this –[Community nurse]Indeed, due to the low intensity of the program and minimal resources required, many stakeholders discussed that their organization would likely have sufficient capacity to implement such a program.Stakeholders provided recommendations to improve program delivery and optimize future scale-up of prevention programs. As previously reported, key recommendations included the development of multi-level partnerships, ongoing mentoring relationships via electronic communication, delivery of programs amongst outlying rural townships, and the provision of a suite of implementation resources to support cost and time-efficient implementation .Process evaluation revealed strong implementation fidelity and high dose delivered and received, confirmed through administration records, researchers observations, and completed program devised checklists, as previously reported. This highlighted the acceptability of low-intensity healthy lifestyle programs with mixed face-to-face and remote delivery modes in this population group. Qualitative participant interviews revealed that group education sessions were most valued, followed by text messages and phone coaching. Overall, delivery of lifestyle advice through multiple delivery modes  was recommended by participants to optimize program acceptability and accommodate diverse learning styles . A full I think [the program] is fantastic and just like the fact that you held it in the first place, I thought oh wow, there’s people that are actually out there to help and yes, it felt like a privilege – [intervention participant]Qualitative participant interviews reported a high level of program acceptability.P < 0.05) and being satisfied with program support than the controls .The 1-year satisfaction surveys showed high participant satisfaction with 82% of the participants agreeing they would recommend this program, with more intervention participants recommending the program (90 versus 73%, The HeLP-her program has been identified as an evidence-based community program by the Victorian State Government as part of a state-wide system-based approach to tackling the rising rates of obesity and preventing obesity-related conditions . This deEmploying Kessler’s et al. RE-AIM meta-evaluation tool, this evaluation assessed all “core” elements of the RE-AIM framework, producing a score of 96% for “fully developed use across all RE-AIM dimensions” Table  40]. We. We40]. The HeLP-her, low-intensity healthy lifestyle program has now been delivered in a range of settings and populations in a series of RCT’s where it effectively improves lifestyle and prevents weight gain , 17, 49.The RE-AIM framework was developed to facilitate translation of research findings into improved population health outcomes, focusing on increasing the reporting of implementation strategies and external program validity . A systeHere, we targeted rural women based on high rates of weight gain, risk of obesity and related complications, adverse impact on maternal and child short- and long-term health, and relative disadvantage for rural women. Despite reported difficulties in engaging socio-economic disadvantaged groups into research , we reacThe HeLP-her Rural program and evaluation has addressed the dearth of literature surrounding the acceptability of low-intensity weight gain prevention programs in young women , 63. TheImplementing, scaling up, and sustaining evidence-based lifestyle programs in diverse real-world settings are notoriously challenging, yet they are fundamental to improve public health outcomes . Here, wStudy strengths include utilizing a robust mixed methods evaluation design with an underpinning theoretical framework and a meta-evaluation that revealed all “core” RE-AIM elements were assessed. However, we note that “adoption” at the staff level was unable to be measured within this context due to program design. Limitations include that our program checklists exploring program fidelity and contextual influences were completed by researchers involved in the trial, rather than independent evaluators. Contextual factors and characteristics could also have been further explored. Furthermore, whilst comprehensive 2-year weight data and program economic analysis are underway, these data are needed to inform program maintenance. Given a large amount of data needed to meet all “core” RE-AIM dimensions, a staged approach to data collection and analysis in RE-AIM evaluation is common.Evidence-based obesity prevention programs such as the HeLP-her healthy lifestyle program have potential for population level scale-up, with broad reach beyond direct participants, demonstrated effectiveness across a range of populations and settings, low-intensity design, and high acceptability at the community and stakeholder levels. Here, we report strong program implementation rigor and comprehensive application of the RE-AIM framework. Moving forward, there is a clear need to redefine lifestyle program success if we are to deliver public health impact. Success must extend beyond effectiveness to incorporate program reach, adoption and potential for implementation and sustainability in diverse real-world settings. This is critical to inform policy and scale-up of lifestyle programs to address the current obesity epidemic.


The objective of the current contribution is to propose an evidence-based, six-step approach to develop effective programs for prevention of fetal alcohol spectrum disorders.Despite widespread campaigns aimed to reduce prenatal alcohol exposure, the number of affected children continues to be high. Current strategies to reduce prenatal alcohol exposure may be ineffective or counterproductive. However, proven principles of health promotion could be applied to reduce drinking in pregnancy. One such approach is Intervention Mapping (IM), a six-step procedure based on proven principles to change behaviors.FASD affects all communities and is an underestimated problem worldwide. Programs based on proven principles of behavior change are warranted. Program developers can use pre-existing protocols and strategies from evidence-based practice, such as Intervention Mapping. Developers who plan their preventive programs in a systematic and evidence-based manner increase the chances of success in reducing prenatal alcohol exposure and FASD. Consumption of ethyl alcohol can have negative impact on health and quality of life. As alcohol consumption is part of an accepted way of life in many countries, the healthcare problems and costs are tremendous. Many persons are unaware of the toxic effect of alcohol and its metabolites on different organs of the body. Children, young adults, women, and in particular pregnant women are very vulnerable to the effects of alcohol that can have lifelong consequences. This is especially the case with fetal alcohol spectrum disorders (FASD). FASD is an umbrella term for a range of birth defects caused by prenatal exposure to ethyl alcohol. Alcohol results in mild to severe damage to the development of the unborn baby –3. This FAS, first named in 1973, comprises several birth defects such as growth deficiency , facial dysmorphology , or central nervous system dysfunction  . In caseSeveral initiatives have been undertaken to achieve a consensus on establishing diagnoses within the spectrum of FASD . The InsMany approaches have been taken in the attempt to prevent FASD. Some approaches are targeted to the general public, including labels on drink containers, large-scale distributions of posters, and flyers or media campaigns, such as the international campaigns taking place annually on September 9, International FASDay . Other aIn many cases, there has unfortunately been inadequate evaluation of the effectiveness of the intervention. For example, many of the campaigns targeted to the public carry out no evaluation at all, or the evaluation is based on the response to questions about awareness of the risks associated with prenatal exposure to alcohol. It is often assumed that heightened awareness of the risks will lead to stoppage of drinking during pregnancy, yet this may not be the case.A comparison with campaigns influencing smoking behavior can be illuminating. For years, many different attempts have been made to address smoking behavior, both effective and ineffective. An ineffective approach is, for example, fear appeal images and texts which are printed on cigarette packages. Research shows that fear appeal interventions are not effective in changing behavior , 23. ForGiven the serious consequences, prevention of prenatal exposure to alcohol is urgently needed. In order to go forward, several recommendations can be made.Prevention is the key in FASD whereby evidence-based practice is of utmost importance. First, it is essential to have a good understanding of what is known and what is still unknown about FASD. Evidence-based practice entails an integration of scientific evidence and clinical expertise to form the basis for FASD prevention and management. An iterative approach can be used for the process of problem identification to solving the problem. In this effort, pre-existing protocols and strategies can be used, such as Intervention Mapping (IM) , 25. IntEach step of Intervention Mapping comprises several tasks Fig. . The comStep 1.Develop a logic model of the problem based on a needs assessment.These six steps could be applied to the prevention of prenatal alcohol exposure and FASD as follows.The first step in development of a systematic evidence-based health promotion program is to conduct a needs assessment or problem analysis by identifying what, if anything, needs to be changed and for whom. Planners need to get a good understanding of the nature, extent, and causes of the health problem before starting to develop a program. The following questions may apply. Is FASD a worldwide problem? The recently conducted meta-analyses of global FASD prevalence estimates can assist . Data waOn the basis of the results of this first problem analysis, planners continue to step 2 to determine the program outcomes and objectives that should lead to a decrease of the health problem.Step 2.State program outcomes and objectives—a logic model for change.Step 3.Develop the program plan, including scope, sequence, change methods, and practical applications.The second step is to create what are known as “matrices of change objectives” by combining behaviors and subsidiary behaviors with behavioral determinants to identify which determinants and beliefs should be targeted by the intervention . This stStep 4.Produce the intervention, including program materials and messages.The third step is to select theory-based behavior change methods that match the determinants into which the identified sub-determinants aggregate and translate these into practical applications that satisfy the parameters for effectiveness of the selected methods . For exaStep 5.Plan program use, including adoption, implementation, and maintenance.Once all components of the program have been developed, these can be integrated into one coherent program. One example is the brochure corresponding with the publication by France and colleagues . The fouStep 6.Develop an evaluation plan.The fifth step is to plan for adoption, implementation, and sustainability of the program. Once a program has been developed, this in itself will not guarantee effectiveness. The program users and implementers need to be identified. The most obvious and important implementers for FASD prevention are healthcare professionals in fields related to pregnancy. Analysis of the stakeholders from the first step can assist in the choice of implementers, as not all relevant stakeholders are motivated or in a position to carry out a program. The process and considerations for adoption, implementation, and sustainability of programs are often not reported.The sixth step is to generate an evaluation plan to measure program effectiveness. For each of the objectives from step 2, a measurable outcome should be determined. Then, the planners specify the evaluation design to conduct effect and process evaluations.FASD is an important health problem which affects individuals and their families worldwide. FASD is caused by prenatal alcohol exposure and is therefore, theoretically, entirely preventable. Development of effective interventions, however, is complex, and if key factors are overlooked, an ineffective or counterproductive program may be the result. Program developers can use pre-existing protocols and evidence-based strategies, such as the Intervention Mapping approach described here.


Recent preclinical and clinical data suggested that LAC may exert antidepressant effects with a more rapid onset than conventional drugs. Herein, we review data supporting LAC antidepressant activity and its distinctive mechanisms of action compared with monoaminergic antidepressants. Furthermore, we discuss the unique pharmacological properties of LAC that allow us to look at this molecule as representative of next generation antidepressants with a safe profile.Current therapy of mood disorders has several limitations. Although a high number of drugs are clinically available, as of today, nearly two-thirds of individuals do not achieve full symptomatic remission after treatment with conventional antidepressants. Moreover, several weeks of drug treatment are usually required to obtain clinical effects, a limitation that has considerable clinical implications, ranging from high suicide risk to reduced compliance. The characteristic lag time in classical antidepressant effectiveness has given great impulse to the search for novel therapeutics with more rapid effects.  Originally, LAC primary function was attributed to its role in the transport of short- and medium-chain acyl groups outside mitochondria, a step required for utilization of fatty acids and glucose [ glucose . Besides glucose ,5,6,7,8.l-carnitine whose function is generally correlated with regulation of energy metabolism within mitochondria [LAC is an endogenous compound widely distributed in many tissues, including brain. Chemically, LAC is the acetylated derivative of the amino acid chondria . Its de chondria ,27. CAT chondria ,29.After being synthetized, LAC is transported outside mitochondria into the cytosol by the enzyme carnitine/acetylcarnitine translocase (CACT) ,31,32. TWhen exogenously administered, LAC is easily absorbed. Due to its amphiphilic structure, LAC is mobile throughout the plasma membranes and can rapidly cross blood-brain barrier ,37. IndeA wide range of mechanisms have been proposed to explain the multiplicity of LAC activities within nervous tissues. In particular, it has been demonstrated that LAC modulates the activity of nerve growth factor (NGF) and enhances the expression of NGF receptors in striatum/hippocampus during development and in aged rats ,40,41. MRecently, evidence that LAC serves as donor of acetyl groups further supported additional functions that go beyond its classical role in energy metabolism. In particular, its ability to contribute to acetylation of -OH or -NH2 functional groups on amino acids and N-terminal groups in proteins ,8,50,51 In humans, and particularly in the elderly, the beneficial effects of LAC has been reported in mood disorders, including major depressive disorder and dysthymia ,59,60. MA recent meta-analysis investigated the effects of LAC on depressive symptoms across published RCT . Again, One interesting form of neuroplasticity is adult neurogenesis, the process of generation of new neurons in adulthood. In the dentate gyrus of hippocampus adult neurogenesis occurs in humans across their entire life span . AlthougAmong regulators of ahNG the NF-κB family of transcription factors has been receiving attention from our and other laboratories ,80,81,82mGlu2 receptor gene expression not only in hippocampus but also in prefrontal cortex [mGlu2 receptor and BDNF gene expression. Of note, a significant reduction of LAC in hippocampi and prefrontal cortex of FSL rats compared to Flinders Resistant Line rats was recently reported, although it was not clear whether LAC mediated antidepressant effects were linked to a correction of its deficiency in those brain regions [In the same year of our findings, a relevant paper confirmed and further extended these observations by demonstrating LAC-mediated antidepressant effects not only following chronic stress, but also in a genetic model of depression, namely Flinders Sensitive Line (FSL) rats . Also inl cortex . LAC antl cortex . Of intel cortex . In line regions .Several critical aspects need to be highlighted and further discussed. First of all, LAC is a non-specific acetylating agent and it is unlikely that its antidepressant and proneurogenic actions are solely due to acetylation of nuclear proteins such as p65 and histones. It is possible that the drug acetylates other, even non-nuclear, target proteins. Further studies should be devoted to the identification of those proteins, which may potentially suggest new pharmacological targets.It should also be underlined that the idea that NF-κB and p65-mediated transcriptional activation per se results in antidepressant or proneurogenic effects is challenged by opposite literature data. Chronic stress augments NF-κB-dependent transcription in the hippocampus  and in NThe fact that both induction and prevention of depressive-like behavior and ahNG may rely on activation of NF-κB signaling pathway is likely to reflect the complexity within that regulatory system. The NF-κB protein family is composed of several members, in addition to p65, which can combine to form dimers with different subunit composition which can be differentially activated and exert distinct, even opposite, functions through activation of specific sets of gene targets ,89,90,91Last but not least, we do not want to infer that NF-κB p65 acetylation and increased mGlu2 gene transcription represent the only mechanisms underlying LAC pharmacological effects. Recent literature data strongly support this idea. In the UCMS paradigm, LAC-mediated reversal of depressive-like behavior was shown to activate a PI3K/AKT/BDNF/VGF signaling pathway . Using eOther literature data contribute to the concept of pleiotropicity of action for LAC antidepressant effects. It has been proposed that LAC may act as an antidepressant via increased levels of the glia-derived growth factor artemin . MoreoveMood disorders are highly prevalent and disabling conditions. Despite a large number of clinically available drugs, as of today, nearly two-thirds of individuals do not achieve full symptomatic remission after treatment with conventional antidepressants . In addiLAC is currently marketed for treatment of neuropathic pain. Several studies, including double-blind placebo-controlled studies, have shown that LAC may represent a consistent therapeutic option for peripheral neuropathies ,103. As In summary, for a long time there have been few drugs mechanistically distinct from classical monoaminergic antidepressants for treatment of mood disorder. LAC represents a next-generation antidepressant drug with novel mechanisms of action and high tolerability. Future investigations of the detailed cellular and molecular mechanisms underlying LAC effects may help in the development of potentially rapidly acting therapeutics and, in parallel, increase our current knowledge on the pathophysiology of depressive disorders.


Erwinia amylovora is the causal agent of fire blight, a devastating disease affecting some plants of the Rosaceae family. We isolated bacteriophages from samples collected from infected apple and pear trees along the Wasatch Front in Utah. We announce 19 high-quality complete genome sequences of E. amylovora bacteriophages. Erwinia amylovora is a Gram-negative facultative anaerobic rod-shaped bacterium and the causative agent of fire blight  and sequenced using 454 pyrosequencing  or Illumina HiSeq 2500 sequencing . Contigs were assembled using Newbler version 2.9  and Consed  and otheThe 19 phages fell into five distinct clusters according to genomic analysis. The first group included the jumbo myoviruses vB_EamM_Deimos-Minion, vB_EamM_RAY, vB_EamM_Simmy50, and vB_EamM_Special G, which share a minimum of 97.2% average nucleotide identity to one another. The second group included two jumbo myoviruses, vB_EamM_RisingSun and vB_EamM_Joad, which differ by only two putative gene products. The third group included diverse jumbo myoviruses vB_EamM_Caitlin, vB_EamM_ChrisDB, vB_EamM_EarlPhillipIV, vB_EamM_Huxley, vB_EamM_Kwan, vB_EamM_Machina, vB_EamM_Parshik, vB_EamM_Phobos, and vB_EamM_Stratton, which share a minimum of 50.5% average nucleotide identity. An additional jumbo myovirus, vB_EamM_Yoloswag, did not have any close phage relatives. Podovirus phages vB_EamP_Frozen, vB_EamP_Gutmeister, and vB_EamP_Rexella share at least 97.2% average nucleotide identity. The four jumbo myovirus groups package DNA by headful packaging based on homology of their putative terminase genes to the phiKZ terminase  and GepaErwinia bacteriophages are listed in GenBank accession numbers for the 19


P = 0.0061), lymphoma , and breast cancer . DcR3 was found to be a suitable biomarker for identifying gastric cancer patients. Importantly, DcR3 was positively associated with platelet distribution width (PDW)  in metastatic cancers but negatively associated with hemoglobin (HGB)  and hematocrit (HCT)  in non-metastatic cancers. Combined with PDW, HGB and HCT, serum DcR3 could be used to predict the occurrence of cancer metastasis. These findings indicate that DcR3 could be used as a biomarker for the diagnosis of gastric cancer, and for cancer metastasis in combination with hematological traits.Decoy receptor 3 (DcR3) is abnormally up-regulated in many cancer cells. It may help cancer cells to escape from immune surveillance and establish metastatic lesions. However, whether DcR3 can be used as a biomarker for the diagnosis of cancer metastasis is unclear. In this study, sera from healthy controls and patients with different cancers were collected, and tested for their DcR3 levels by ELISA. Significantly elevated DcR3 levels were observed in the sera of patients with gastric cancer (2.04 ± 1.01,  Decoy receptor 3 (DcR3), also known as tumor necrosis factor receptor superfamily member 6B (TNFRSF6B), is a soluble protein that competitively binds Fas ligand . DcR3 haHematological traits are important clinical parameters and closely related to malignancies such as colorectal cancer . PlateleMetastasis is a major cause of mortality in cancer patients. Tumor cells must escape from immune surveillance in cancer metastasis , 20. DcRR2 = 0.9941). The results showed significant elevations of DcR3 in gastric cancer , lymphoma , and breast cancer , but not in other cancers tested  in subjects with metastatic cancers  and HCT  in subjects with non-metastatic cancers  showed with better specificity, higher sensitivity, and greater accuracy than DcR3 alone   Equation 1Even in the face of the best currently available medical and surgical treatments, the overall prognosis of patients with metastatic cancers remains poor. In this study, we collected serum samples from patients with different caners and analyzed the DcR3 level. Results indicated an abnormal elevation of DcR3 in gastric cancer, lymphoma, and breast cancer. Results also suggested that DcR3 was a candidate biomarker for the highly specific and sensitive diagnosis of gastric cancer. Further investigation revealed that serum DcR3 was positively associated with PDW in metastatic cancers and negatively associated with HGB and HCT in non-metastatic cancers. The combined detection of DcR3, PDW, HGB, and HCT acts as a better biomarker than DcR3 alone with respect to differentiating cancer metastasis from non-metastasis.Numerous studies have shown DcR3 expression to be markedly increased in metastatic cancers, such as esophageal cancer , gastricPrevious studies have indicated that platelet activation plays a key role in cancer metastases , 34. PlaThe current study suggests that a higher DcR3 level in non-metastatic cancers is associated with both lower HCT and lower HGB, which indicate anemia in patients. High DcR3 levels are associated with cancer malignant progression, which is a consequence of complex interactions between the host microenvironment and tumor cells . Anemia The study has two limitations. Firstly, from this study, 58 metastatic and 32 non-metastatic cases as well as 25 controls are included, which is a relatively small sample size. Secondly, the participants are all Chinese. Thus, further studies are needed to be conduct for other ethnic groups.Our findings indicate that DcR3 is a potential biomarker for the detection of cancer cell metastasis across multiple cancer types; this biomarker could provide scientific clues for the evaluation and use of DcR3 in clinical diagnosis.The collection of human sera was approved by Ethics Committee of Shenzhen Second People's Hospital from January 2016 to December 2016. Informed consent was obtained from all patients and controls. All experiments using human blood samples were following the related technical and ethical guidelines. In our study, Sera from 90 tumor patients and 25 healthy individuals were collected during the same period. The mean age and age range at the time of diagnosis were 49 years and 24 to 92 years, respectively. Whole blood samples were collected in EDTA-containing tubes from the individuals with data on routine blood tests including platelet distribution width, hematocrit and hemoglobin, before initiating any treatment. All samples were processed within 30 min of blood collection.The 96-well EIA/RIA high binding plates and bovine serum albumin (BSA) were bought from Sigma-Aldrich . Tris-buffered saline containing 0.05% Tween-20 (TBST), was acquired from double-helix . Tetramethylbenzidine dihydrochloride (TMB) and sulfuric acid were purchased from Sangon . Chinese hamster ovary cells, serum-free medium and spinner flasks were bought from Invitrogen . The DcR3 ELISA kit was purchased from R&D .Full-length human DcR3 cDNA fused to the sequence encoding the Fc domain of human IgG1 was here synthesized and cloned into a pcDNA3.1 expression vector . Chinese hamster ovary cells were transfected with this expression vector and grown in serum-free medium using a spinner flask. The soluble DcR3-Fc was purified from the medium and a panel of anti-DcR3 monoclonal antibodies against the recombinant protein was produced by hybridoma technology.We paired two antibodies, 5C3 and 4E7, to serve as capture and detection antibodies in double-antibody sandwiched ELISA. These antibodies both selectively recognized soluble DcR3 with higher sensibility and wider linear range than the DcR3 ELISA kit purchased from R&D (187–12000 pg/ml). Capture antibody was immobilized on the high binding plate. The plate was then blocked using 1% BSA. The plate was incubated with standards and serum samples at room temperature for 2 h, washed in TBST and incubated with detection antibody at room temperature for another 2 h. The plate was then sequentially incubated with streptavidin-HRP conjugations, TMB, and 1 mol/L of sulfuric acid. Data were recorded (at 450 nm) using a M1000 (Tecan) plate reader.t test was used to evaluate the statistical significance of the difference in DcR3 between metastatic and non-metastatic cancers. The odds ratio (OR) and 95% confidence interval (95% CI) were calculated using multivariate logistic regression analysis. The statistical analysis was performed using GraphPad Prism version 5.0 for Windows .Receiver operating characteristic (ROC) curve was used to analyze the classification power of candidate biomarkers. Pearson's test was used for correlation analysis between DcR3 and blood test indicators. The student's The collection of human sera was approved by the Ethics Committee of Shenzhen Second People's Hospital. Informed consent was obtained from all patients and controls. All experiments using human blood samples were following the related technical and ethical guidelines.


The original publication  is missi“This work was funded by National Key Basic Research Program of China (2015CB655005) and Science and Technology Commission of Shanghai Municipality Program (14DZ228090).”


Purpose To evaluate effects on somatic and mental health of a multicomponent inpatient occupational rehabilitation program compared to a less comprehensive outpatient program in individuals on sick leave for musculoskeletal complaints or mental health disorders. Methods A randomized clinical trial with parallel groups. Participants were individuals on sick-leave for 2–12 months with a sick-leave diagnosis within the musculoskeletal, psychological or general and unspecified chapters of ICPC-2. Potential participants were identified in the Social Security System Registry. The multicomponent inpatient program (4 + 4 days) consisted of Acceptance and Commitment Therapy, physical training and work-related problem-solving including creating a return to work plan and a workplace visit if considered relevant. The comparative outpatient program consisted primarily of ACT (6 sessions during 6 weeks). Self-reported health-related quality of life, subjective health complaints, pain and anxiety and depression symptoms were assessed up to 12 months after the program. Results 168 individuals were randomized to the multicomponent inpatient program (n = 92) or the outpatient program (n = 76). Linear mixed models showed no statistically significant differences between the programs, except for slightly more reduced pain after the outpatient program. Conclusions This study presents no support that a 4 + 4 days multicomponent inpatient rehabilitation program is superior to a less comprehensive outpatient program, in improving health outcomes.The online version of this article (doi:10.1007/s10926-016-9679-5) contains supplementary material, which is available to authorized users. Musculoskeletal and mental health disorders are the two leading causes of sickness absence in Norway . Five peMost occupational rehabilitation programs described in the scientific literature are directed towards specific diagnostic groups, mainly musculoskeletal disorders , 4. EffeIn Norway, the occupational rehabilitation services offer both inpatient and outpatient programs to increase work participation and improve health outcomes for patients on sick-leave, and the inclusion of different diagnostic groups in the same rehabilitation programs has been common practice for several years . HoweverWe evaluated the effects of the multicomponent program delivered at the inpatient occupational rehabilitation center by comparing it to a less comprehensive outpatient program consisting mainly of ACT. In a recent study with 12 months of follow-up we found no difference between the programs on number of sickness absence days and return to work (under review). Here, we present results of secondary outcomes related to health as the programs also aimed to improve the participants` health status and health perception.We hypothesized that the inpatient program, to a greater extent than the outpatient program, would reduce pain, depression, anxiety and subjective health complaints and increase function and health-related quality of life.We conducted a randomized clinical trial with parallel groups, comparing an inpatient multicomponent program (4 + 4 days) with a single-component program (6 sessions during 6 weeks)  for individuals on sick-leave due to musculoskeletal-, unspecific-, or common mental health disorders. Details about the study design have been published elsewhere . The priEligible participants were individuals aged 18 to 60 years sick listed 2–12 months with a diagnosis within the musculoskeletal (L), psychological (P) or general and unspecified (A) chapters of ICPC-2 . Sick leave status at inclusion had to be at least 50 % off work. Exclusion criteria, assessed by a questionnaire and an outpatient screening performed by a physician, a physiotherapist and a psychologist, were: (1) alcohol or drug abuse; (2) serious somatic  or psychiatric disorders ; (3) specific disorders requiring specialized treatment; (4) pregnancy; (5) currently participating in another treatment or rehabilitation program; (6) insufficient oral or written Norwegian language skills to participate in group sessions and fill out questionnaires; (7) scheduled for surgery within the next 6 months; and (8) serious problems with functioning in a group setting.Data was obtained by questionnaires and filled out at six time-points: at screening before inclusion, at the start of the program, at the end of the program, and three, six and 12 months after the inpatient program ended.Consisted of group discussions (ACT based) led by team coordinators, individual and group based physical training, mindfulness, psychoeducation on stress and individual meetings with coordinator for work-related problem- solving and creating a return to work plan. The intervention lasted four full workdays in week 1 and week 4 , separated by 2 weeks at home (week 2 and 3). The two weeks at home included at least two contacts with the team coordinator (in person or by telephone) and a meeting with the employer if regarded relevant and the participant gave permission. A certified ACT instructor supervised the coordinators who mentored the participants before and during (monthly) the intervention. The program took place at Hysnes rehabilitation center, established as a part of St. Olavs Hospital, in central Norway. A more detailed description of the program has been published elsewhere .Consisted of group based ACT. The sessions were held at the Department of Physical Medicine and Rehabilitation at St. Olavs Hospital once a week for six weeks, each session lasting 2.5 h. One of two physicians  or a psychologist, all three educated in ACT, led the sessions. The participants were encouraged to practise at home between sessions, including a daily 15 min audio-guided mindfulness practice. In addition the participants were offered two individual sessions with a social worker experienced in occupational rehabilitation and trained in ACT to clarify personal values and work-related issues. The intervention also included a motivational group discussion with a physiotherapist on the benefits of physical training. An individual session with both the social worker and ACT therapist present ended the intervention. In this session a summary letter was written to the participant’s general practitioner. A more detailed description of the program has been published elsewhere .Self-reported data on health and functioning were collected via internet-based questionnaires. The participants received text messages on their mobile telephone when it was time to answer questionnaires and as reminders if they did not respond. If they had not responded after two text-message reminders a project co-worker made a final phone call to remind the participant.Anxiety and depression were recorded using The Hospital Anxiety and Depression Scale (HADS) . It consCommon somatic and mental health problems were recorded using The Subjective Health Complaints Inventory (SHC) , which rTo assess pain we used two questions from the Brief Pain Inventory (BPI) . The parHealth-related quality of life was recorded using 15D . It contFunctioning was recorded using COOP/WONKA . It offeParticipants were asked to evaluate their general health on a 4-point Likert scale from 1 “poor” to 4 “very good”. The variable was analysed both dichotomized (poor/not very good vs. good/very good) and as a continuous score (range 1–4). The question was answered at all time-points, except at screening.The present study was part of a larger trial comparing the current (4 + 4 days) and a longer (3.5 weeks) inpatient program, an outpatient program, as well as a treatment as usual control group only followed in sick leave registers see Fig. . The curParticipants were randomized twice. Firstly, sick listed individuals identified in the Social Security System were randomized to receive an invitation to either the long or short program. Invited participants randomized to the short program completed a short initial questionnaire assessing eligibility. Those eligible were invited for an outpatient screening assessment. If the screening was passed Fig. , the secIt was not possible to blind neither the participants nor the caregivers for treatment. Outcomes were measured using web-based questionnaires that the participants filled out independently on their own. The researchers were not blinded.Sample size was calculated based on the primary outcome, i.e. number of sickness absence days (under review), resulting in 80 persons in each arm. Details about the estimations are published elsewhere .p values (two-tailed) <0.05 to be statistically significant. Precision was assessed using 95 % confidence intervals.Under the intention to treat principle we used linear (and logistic) mixed-effects models to compare outcome measures of health and function over time for the two rehabilitation programs. In addition to program and time (time points 1–6) we included an interaction term between program and the six time-points in the analyses to assess whether the effects of the programs differed over time. Repeated measurements (at the different time-points) were handled by including a random intercept for person in the models  and a random slope for time . The estimates from the analyses (fixed effects) were used to predict health outcomes at different time points for the two programs. We considered In the main analyses we did not adjust for baseline characteristics, but this was done in sensitivity analyses  to assess the robustness of the results. Supplementary “per protocol” analyses were done by excluding participants that withdrew after randomization (before or during the programs) and/or attended less than 60 % of the sessions of the outpatient program.2 test, t test or Mann–Whitney U test. Median numbers of sickness absence days were compared by Mann–Whitney U test.Baseline characteristics for responders and non-responders to the 12 month follow-up questionnaire were compared using χAll analyses were done using STATA 13.1 .In brief, 12 007 potential participants from the regional area were identified in the National Social Security System Registry. Of these, 3 318 were randomized to receive an invitation to the short program and 275 accepted. After screening 107 persons were excluded, withdrew or did not meet for their appointment. The remaining 168 persons were randomized to the inpatient program (n = 92) or the outpatient program (n = 76). The groups consisted of maximum 9 participants. The flow of participants through the study is illustrated in Fig. For the inpatient program, 14 people withdrew before they began the program and four quit during the program. For the outpatient program, five people withdrew before the program started and eight during the program. Those who started the outpatient program attended on average 7.9 of the 10 meetings and 59 (83 %) attended at least 60 % of the sessions. For the inpatient program there is no data for number of sessions participants attended, but as it was an inpatient program the participants were assumed compliant if they did not withdraw. All randomized participants were included in the analyses.The number of people who answered the questionnaires decreased steadily through the study. For the inpatient program 100 % of the participants answered the questionnaire before the screening, 85 % at the start of program, 71 % at the end of the program, 50 % at three months, 58 % at six months and 43 % at 12 months after the program. For the outpatient program the numbers were 99, 78, 59, 49, 54 and 47 %, respectively. One participant in the outpatient program answered none of the questionnaires. At least 3 questionnaires were filled out by 72 % of the participants. A workplace visit was performed for 13 % of the participants randomized to the inpatient program.The participants were mainly women (79 %), and their mean age was 45 years SD 9.1) (Table  (Table 1p = 0.03) in favor of the outpatient program.Only one of the health measures, strongest pain, showed a statistically significant difference between the programs Fig. . The estBoth programs showed increased health-related quality of life from start of the programs to 12 months . For the HADS depression subscale there was a somewhat larger reduction in symptoms for participants with a psychological diagnosis. The same was observed for the HADS anxiety subscale for the inpatient program, while for the outpatient program there were only minor differences between the diagnostic groups. For average pain there was little difference between participants with a musculoskeletal- and psychological diagnosis for both programs. When performing the analyses for participants having the highest baseline scores on anxiety, depression and pain the results were similar to the main analyses. The differences between the two programs from start of the programs to 12 months were not statistically significant in any of the subgroup analyses.p = 0.023). The other baseline values were fairly similar. The median number of sickness absence days during 12 months of follow-up were 87 (IQR 39–146) for the responders and 112 (IQR 44–185) for the non-responders (p = 0.252).The participants not answering the questionnaire at 12 months were younger than the responders (mean age 43.6 (SD 9.3) vs. 46.7 (SD 8.6), This randomized clinical trial showed no differences in self-reported health measures between a 4 + 4 days inpatient multicomponent occupational rehabilitation program and a less comprehensive outpatient program consisting mainly of group-based ACT, except for slightly more reduced pain after the outpatient program.We are not aware of studies comparing inpatient and outpatient return to work programs. No substantial difference on somatic and mental health outcomes between the two rehabilitation programs is in line with some earlier studies on individuals with musculoskeletal complaints , 32 and Most occupational rehabilitation programs described in the scientific literature use some sort of cognitive behavioral therapy approach , 11. In We found an increase in health related quality of life in both groups measured by 15D, estimated to be 0.03 (95 % 0.01–0.06) for the inpatient program and 0.05 (95 % CI 0.02–0.07) for the outpatient program. The clinical importance of this change is uncertain, but it is in the area of cut-off suggested as a minimum important change . When thFew randomized studies have included participants with different diagnoses in the same return to work programs. As we included individuals on sick leave due to musculoskeletal, mental or general/unspecific disorders, some had pain and others not, which was also the case for anxiety and depression symptoms. This would likely reduce the statistical power to detect between group effects. However, we performed subgroup analyses according to the participants` main sick-leave diagnosis. Participants with a psychological diagnosis had a somewhat larger reduction in depression symptoms than participants with a musculoskeletal diagnosis. However, there was no difference between participants with musculoskeletal and psychological diagnoses in reductions of average pain. As a substantial degree of overlap in symptoms is common in these patients , 36 and The main strength of this randomized study was that all participants were invited from the Social Security System Registry, meaning there was no referral bias. Return to work rehabilitation centers have existed for about 30 years in Norway, but this is the first randomized controlled study investigating effects on somatic or mental health of such programs. The programs were not diagnosis specific and add important knowledge to a field where previous research has focused on diagnosis specific interventions. Also, the study included a broad range of validated health-related measures.Some limitations should be addressed. Firstly, the response rate for the questionnaires were low at 3, 6 and 12 months. At the start and the end of the programs, more people answered the questionnaires in the inpatient program than in the outpatient program. The participants in the inpatient program answered the questionnaire at the rehabilitation center, while the outpatient participants did it at home. During follow-up, questionnaires were answered at home for both groups and the numbers of missing questionnaires were similar. We therefore assume that the structural differences in collecting questionnaire data account for the differences in responses between the two groups at the start and end of the intervention. For analyses we used linear mixed models which are less sensitive to missing values in outcome data. Still, these models rely on the assumption of “missing at random”, and we cannot disregard the possibility of bias due to loss to follow-up. However, we consider it unlikely that such bias should influence the two groups differentially and thereby the main results of the study. This assumption is strengthened by register-based sick leave data showing a similar number of sick leave days during 12 months of follow-up between participants responding/not responding to the questionnaire at 12 months.In the current study there was no usual care control group. Therefore, we cannot distinguish between the effects of rehabilitation and time. It should also be noted that the power calculation for the study was done with regard to the primary outcome (sickness absence) and not the secondary outcomes presented in this article.With regards to external validity it should be noted that from the over 3000 invitations sent, only 275 individuals accepted the invitation. A possible explanation might be that they had to be prepared to be away from their family for 2 weeks if randomized to the inpatient program. With only about 8 % of the invited accepting the invitation the generalizability of the results is a challenge. However, it should be noted that only a small portion of people on sick leave in Norway are referred to occupational rehabilitation centers. By inviting participants this broadly we were able to reach all individuals on sick-leave with these diagnoses without referral bias induced by the general practitioner.There was no substantial difference between the programs on somatic and mental health; hence, this study presents no support that a 4 + 4 days inpatient multicomponent rehabilitation program is superior to a less comprehensive outpatient program. Whether a longer lasting inpatient program will have greater effects on somatic and mental health will be investigated in an upcoming study.Supplementary material 1 (DOCX 29 kb)Below is the link to the electronic supplementary material.


Dear Editor,A 58-year-old male sought treatment complaining of dyspnea on exertion, together withcough and occasional mucus secretion. He reported having been treated for asthma 14years prior, as well as having used bronchodilators and inhaled corticosteroids,although he stated that he had experienced no asthma symptoms in childhood.Computed tomography (CT) was performed  and 1C, . Depending on the anatomical distribution, amyloidosiscan be classified as systemic (involving multiple organs) or localized (involving asingle organ). In the biochemical classification, based on the type of fibrillarcomponent in amyloid deposits, there are innumerable subtypes. In the vast majority ofcases, light-chain amyloid fibrils and serum amyloid A are identified.Amyloidosis encompasses a set of diseases characterized by deposition and abnormalaccumulation of protein material in organs and tissues,2. Pulmonary involvement is rare, reported astracheobronchial, diffuse/alveolar-septal, or nodular manifestations, the first beingthe most common-4.In the thoracic compartment, amyloidosis typically affects the heart but can also involvethe pulmonary parenchyma, pleura, lymph node chains, tracheobronchial tree, and othersites.The tracheobronchial manifestation of amyloidosis is characterized by the deposition ofamyloid material in the trachea and main bronchi, resulting in thickening of the walls,narrowing of the lumina, and consequent airway obstruction, as well as consolidations,atelectasis, pulmonary hyperinflation, and bronchiectasis,5. The symptoms can be similar to those of bronchial diseases that aremore common, including bronchial asthma.Clinically, amyloidosis-related tracheobronchial impairment can be asymptomatic or canmanifest as dyspnea, wheezing, hemoptysis, cough, or recurrent pneumonia-9, as well as for that of diseases of thetracheobronchial tree-12. In individuals with amyloidosis, aCT scan can reveal smooth or irregular/nodular thickening of the tracheal wall andbronchi, which can be accompanied by calcified nodules in the submucosa. The differential diagnoses of diffusetracheobronchial diseases include vasculitis (Wegener's granulomatosis),tracheobronchial papillomatosis, infectious involvement , tracheopathia osteochondroplastica, andrelapsing polychondritis. Unliketracheal involvement in tracheopathia osteochondroplastica or relapsing polychondritis,tracheobronchial amyloidosis involves the posterior membranous wall of thetrachea,13.Chest CT has been shown to be the imaging exam of choice for the evaluation of thoracicdiseases,13.Histopathological findings of the disease include amyloid thickening of the submucosa,in nodular masses or laminae, showing apple-green birefringence after staining withCongo red. There is also areduction in the number of submucosal glands, together with calcifications and foci ofbone metaplasia in the upper airways.In individuals with amyloidosis, bronchoscopy usually shows thickening of the walls ofthe trachea and bronchi, with flat, multifocal, grayish-yellow plaques in the tracheaand bronchi. In rare cases, amyloid pseudotumors can be seen. The patient inquestion was initially diagnosed with asthma but did not respond to treatment, and thedefinitive diagnosis of primary tracheobronchial amyloidosis was made after a directedfollow-up assessment. We can conclude that, albeit rare, tracheobronchial amyloidosisshould be considered in such patients.In patients suspected of having bronchial asthma who present with atypical symptoms andrespond poorly to clinical treatment, various differential diagnoses should beconsidered


African Americans have high disease and death rates due to cancer and cardiovascular disease. Health promotion efforts to improve diet have the potential to reduce these rates.Given their importance in the community and the extent of their reach, churches are effective avenues for health promotion efforts targeting African Americans. The objectives of this project were to promote healthy eating among African American church members, engage African American churches in the implementation of Body and Soul , and implement the program in the community with minimal resources.From 2011 through 2014 we conducted a community engagement project to implement the 12-week Body and Soul program, which includes demonstrations of healthy recipes and peer counseling, in 20 churches. Participants (n = 310) completed baseline and follow-up surveys on their eating habits and experience with peer counseling. Church coordinators (n = 11) completed a survey evaluating the program.P < .001) and vegetables  increased. Church coordinators reported enthusiasm about Body and Soul at their church, and 10 of 11 church coordinators indicated that their pastor encouraged members to attend Body and Soul events. Program success was promoted by engaging the pastor in program activities and by scheduling events soon after church services. Implementation challenges were variation in peer counseling among churches and low turnout at follow-up events.Participants’ weekly servings of fruit (baseline, 4.3; follow-up, 5.4; The project was successfully implemented in the 20 churches, and increases in healthy eating were observed. This project demonstrated that Body and Soul can be implemented in communities with little funds or other resources. Despite declining rates of cancer deaths among adults in the United States, rates for African American men are 27% higher than for white men and rates for African American women are 14% higher than for white women . To measure the outcome of engagement efforts, we conducted an evaluation following completion of the project of each level of the Body and Soul program. The evidence-based Body and Soul program was developed by the National Cancer Institute as part of its work with African American churches to increase the intake of fruits and vegetables among church members ,14. The This study was a partnership between the University of Minnesota’s Center for Health Equity (CHE) and the Stairstep Foundation (Stairstep), which works with over 45 African American churches in the Twin Cities (the Minneapolis–St. Paul metropolitan area of Minnesota) on social and health issues. CHE leaders contacted Stairstep about partnering with them on a community health project that would be supported by the CHE grant. Stairstep agreed and invited 20 churches to participate in the project. Church leaders saw high death rates from cancer and cardiovascular disease as a pressing issue facing the community and selected the Body and Soul program. They then provided insights on how to adapt the program to their needs and implement the program in a culturally competent way.CHE worked with Stairstep to adapt and implement the program and to resolve measurement issues. Monthly meetings between CHE, Stairstep, and church coordinators were held to discuss program progress, challenges, and findings from each church. After completion of the project, all the churches were invited to an event in the community where project findings were shared with church members, coordinators, and pastors. CHE and Stairstep also held events for church coordinators to share their thoughts on the successes and challenges of implementing the program in their churches.From 2011 through 2014, 20 churches conducted the 12-week Body and Soul program, which included kick-off and follow-up events and peer counseling sessions. The events, which occurred after Saturday or Sunday services, consisted of a study staff member demonstrating healthy recipe preparations, presenting healthy food options, and providing encouragement on healthy eating habits. Volunteer nurses provided participants with health information  . Church Participants completed surveys at kick-off events and 12 weeks later at follow-up events. The surveys were adapted from Body and Soul surveys ,14,16,17Eleven church coordinators who attended a follow-up meeting with CHE and Stairstep at the end of the project completed an 18-item survey evaluating the Body and Soul program. Six of the church coordinators were from phase 1 and 5 were from phase 2. Church members in phase 2 completed an evaluation of peer counseling as part of the follow-up survey.Participants were asked to report their sex, age, marital status, and highest education level completed. They were asked how many times in the past month they ate at a fast food restaurant and how many servings they consumed of a certain food, per week . Foods included were sweetened beverages (8 oz or 1 cup), 100% fruit juice (8 oz or 1 cup), fruit (1/2 cup), green salad (2 cups), and vegetables  ,18. ThesWe used 10 items to measure self-efficacy to eat more fruits and vegetables  ,17. AnswLow-fat and high-fat vegetable preparation practices were each measured using 4 items that assessed how often participants carried out certain vegetable preparation practices ,19,20. LParticipants were asked how much encouragement they got from family, friends or work colleagues, and church members to eat more fruits and vegetables, ranging from 1 (none) to 4 (a lot). Participants were also asked how many times a month fruits and vegetables were served at church functions , which was treated as a continuous variable .Participants were asked how active  and physically active  they were during the previous 2 weeks, ranging from 1  to 6 (extremely active). Participants were also asked how many minutes a day they walked for exercise. Extreme outliers for minutes of walking exercise were replaced by the next highest value (7 outliers).Participants were asked to report the number of peer counseling sessions they attended and how they felt about a series of statements  that probed their response to conversations with a peer counselor. Answer options ranged from 1  to 4 (very true).Church coordinators were asked to rate how much they agreed or disagreed with a series of statements . Answer options ranged from 1 (strongly disagree) to 5 (strongly agree). They were also asked to indicate the ways in which their pastor was involved in the program , whether the Body and Soul program at their church included peer counseling sessions , if the amount of fruit and vegetables served at church events had increased, and if the amount of fried food, sweets, and snacks served had decreased. Last, they were asked how many sessions took place during the 12-week program 2 tests to examine each demographic variable by follow-up status. Descriptive statistics were performed for eating habits, support to eat healthfully, and physical activity at baseline and follow-up. Paired t tests were conducted to examine changes from baseline to follow-up. Participants had to complete both the baseline and follow-up surveys to be included in the paired t tests. Descriptive statistics were examined for the evaluation of peer counseling by church members and evaluation of the program by church coordinators.Descriptive statistics were performed for the demographics, which were examined by follow-up status (completed baseline and follow-up vs. completed baseline only). We performed χTwenty churches and 310 church members participated in the program; 305 participants (98%) completed the baseline survey, 194 (63%) completed the follow-up survey, and 189 (61%) completed both the baseline and follow-up surveys. Of those 189, most were female (77%) and most were aged from 45 to 64 years (59%) . Church P < .001), green salad , and vegetables  increased from baseline to follow-up , support to eat healthfully from family members , and level of physical activity in the previous 2 weeks  also increased from baseline to follow-up.The average weekly servings of fruit  indicated their pastor encouraged members to attend the Body and Soul events; 7 of 11 said their pastor was present at Body and Soul events; all 11 said the amount of fruits served at church events increased; and 9 of 10 said the amount of vegetables had increased . Of the A major achievement of the project was that the Body and Soul program was successfully implemented in church communities, and the project established the potential for other churches to implement the program without investing substantial resources. However, there were challenges. One was participant recruitment. Some churches had low turnout and other churches over-recruited. An additional challenge was that the dose and method of peer counseling varied from church to church. Some church coordinators made weekly calls, monthly calls, or only a few calls, while others had regular face-to-face meetings with individuals or a group. Another challenge was that many participants did not show up to the follow-up event because of travel problems, illness, and other day-to-day constraints, and therefore did not complete the follow-up survey.Success of the program was increased by the enthusiasm of the church coordinators and the engagement of the pastors, who encouraged congregants to participate in the program and were present at Body and Soul events. Success of the program was also promoted through the timing of the events. Because the kick-off and follow-up events were held at each church on a Saturday or Sunday after weekly services, it was convenient for church members to participate in Body and Soul. The timing of the events was also helpful in encouraging the pastors to be present at the events.One unexpected issue regarding the timing of the events was that many participants fasted before church and were quite hungry after church services, and we did not provide a full meal at the events. An additional unexpected issue was that many participants did not complete the follow-up survey: only 63% did so. However, examination of the baseline demographic characteristics revealed little differences between those who completed follow-up and those who did not . AnotherDespite the challenges of implementing this program, communication between CHE and Stairstep was effective. Leaders from CHE and Stairstep met in person monthly at Stairstep and kept in regular communication via email and telephone. Stairstep was the point of contact for the church coordinators and set the tone for church coordinators’ involvement in and enthusiasm about the project. Community participation varied from church to church and was driven in large part by the leadership and passion of the church coordinators. Since the end of the project, Stairstep expanded its network of church coordinators to 23 and meets with them monthly to provide information and training that allows church coordinators to customize health strategies for their churches.This project focused on promoting healthy eating among African American church members and on engaging 20 African American churches in implementing the Body and Soul program. The program had success in increasing the fruit and vegetable intake among the participants. Additionally, church coordinators were highly satisfied with the program and noted increases in the amount of fruits and vegetables served at church functions as a result of the program. Our findings are consistent with previous Body and Soul studies that found increases in fruit and vegetable consumption and changes to church policies around healthy eating ,14–16. AThis project demonstrated that the Body and Soul program can be implemented and succeed in a low-cost, low-resource, real-world setting. It would be worthwhile for future projects to investigate the longevity of the results of the Body and Soul program in the community by following up with churches to see whether the integrity of the program was maintained or whether changes in church practices regarding serving healthier food at functions were sustained over time. It would also be worthwhile for future projects to determine which factors  contribute most to a successful and sustainable Body and Soul program.Communities that are interested in implementing the Body and Soul program should aim to generate enthusiasm among church coordinators and should engage pastors in promoting and participating in the program, because they serve as an inspiration to their congregants. To avoid low turnout, congregations should ensure that kick-off and follow-up events are at a time when most congregants can attend. Last, communities should ensure that church coordinators have the time and ability to provide 12 weekly peer counseling sessions, given that participants in our study found these sessions to be helpful. If these aims are met, greater increases in fruit and vegetable consumption may be observed.Despite the challenges, the project was a success, and the primary objectives of the project were achieved: healthful eating habits increased among congregants, and the Body and Soul program was implemented in 20 African American churches where it touched the lives of more than 300 congregants. Furthermore, if the implementation and evaluation of the program serves to convince church leaders of the benefits of the program, Body and Soul may be sustained and could continue to yield rewards.