Thermotolerance in S. cerevisiae as a model to study extracellular vesicle biology.

The budding yeast Saccharomyces cerevisiae is a proven model organism for elucidating conserved eukaryotic biology, but to date its extracellular vesicle (EV) biology is understudied. Here, we show yeast transmit information through the extracellular medium that increases survival when confronted with heat stress and demonstrate the EV-enriched samples mediate this thermotolerance transfer. These samples contain vesicle-like particles that are exosome-sized and disrupting exosome biogenesis by targeting endosomal sorting complexes required for transport (ESCRT) machinery inhibits thermotolerance transfer. We find that Bro1, the yeast ortholog of the human exosome biomarker ALIX, is present in EV samples, and use Bro1 tagged with green fluorescent protein (GFP) to track EV release and uptake by endocytosis. Proteomics analysis reveals that heat shock protein 70 (HSP70) family proteins are enriched in EV samples that provide thermotolerance. We confirm the presence of the HSP70 ortholog stress-seventy subunit A2 (Ssa2) in EV samples and find that mutant yeast cells lacking SSA2 produce EVs but they fail to transfer thermotolerance. We conclude that Ssa2 within exosomes shared between yeast cells contributes to thermotolerance. Through this work, we advance Saccharomyces cerevisiae as an emerging model organism for elucidating molecular details of eukaryotic EV biology and establish a role for exosomes in heat stress and proteostasis that seems to be evolutionarily conserved.

The effects of using a flipped classroom pedagogy in nursing anesthesia education: a program evaluation.

BACKGROUND: The flipped classroom (FC) pedagogy improves undergraduate student proficiency and satisfaction. However, its effectiveness has not been demonstrated in nursing anesthesia education. OBJECTIVES: Pre- and post-FC tests and course evaluations were retrospectively compared to determine if FC was an effective pedagogy for a nursing anesthesia program (NAP). METHODS: The design of the study was a retrospective program evaluation. Two groups were compared with 59 students in the pre-FC group taught via traditional lecture and 61 students in the post-FC group taught with FC. Answers to the same 167 test questions were compared using an independent t-test and five course evaluation questions were statistically compared using NPAR1WAY procedure with the Wilcoxon option to determine if significant differences existed between the two nursing anesthesia student cohorts. RESULTS: The post-FC students exhibited a significant 4 % increase in test scores and expressed increased satisfaction compared to their pre-FC counterparts. CONCLUSIONS: This retrospective program evaluation showed that student proficiency and satisfaction improved between the groups after changing to the FC pedagogy. However, research is needed to determine the true value of using FC in nursing anesthesia education. IMPLICATIONS FOR AN INTERNATIONAL AUDIENCE: The flipped classroom model can be beneficial in graduate nursing education with our ever-changing student population.

Transforming healthcare documentation: harnessing the potential of AI to generate discharge summaries.

BACKGROUND: Hospital discharge summaries play an essential role in informing GPs of recent admissions to ensure excellent continuity of care and prevent adverse events; however, they are notoriously poorly written, time-consuming, and can result in delayed discharge. AIM: To evaluate the potential of artificial intelligence (AI) to produce high-quality discharge summaries equivalent to the level of a doctor who has completed the UK Foundation Programme. DESIGN & SETTING: Feasibility study using 25 mock patient vignettes. METHOD: Twenty-five mock patient vignettes were written by the authors. Five junior doctors wrote discharge summaries from the case vignettes (five each). The same case vignettes were input into ChatGPT. In total, 50 discharge summaries were generated; 25 by Al and 25 by junior doctors. Quality and suitability were determined through both independent GP evaluators and adherence to a minimum dataset. RESULTS: Of the 25 AI-written discharge summaries 100% were deemed by GPs to be of an acceptable quality compared with 92% of the junior doctor summaries. They both showed a mean compliance of 97% with the minimum dataset. In addition, the ability of GPs to determine if the summary was written by ChatGPT was poor, with only a 60% accuracy of detection. Similarly, when run through an AI-detection tool all were recognised as being very unlikely to be written by AI. CONCLUSION: AI has proven to produce discharge summaries of equivalent quality to a junior doctor who has completed the UK Foundation Programme; however, larger studies with real-world patient data with NHS-approved AI tools will need to be conducted.

Teaching Nurse Practitioner Students Advanced Health Assessment Skills During COVID-19.

The purpose of this project was to evaluate student outcomes before and during the coronavirus disease 2019 (COVID-19) pandemic in an advanced health assessment course that was offered in the summer semesters to nurse practitioner (NP) students as a hybrid course with online didactic and in-person lab components. Due to COVID-19, the summer 2020 course offering transitioned to being 100% online and innovative strategies replaced the in-person labs. Student outcomes from summer 2019, when the course was hybrid, were compared to summer 2020, when the course was changed to being 100% online. The findings of this project showed somewhat similar learning outcomes on both knowledge and skill acquisition in the 100% online course despite the change to 100% online during COVID-19. In teaching advanced health assessment to NP students, use of videography for skills demonstration, the virtual classroom, and unfolding case studies provided a robust and flexible pedagogy approach for 100% online teaching during a pandemic. [J Contin Educ Nurs. 2022;53(2):83-89.].

Does Parental Migration During Childhood Affect Children's Lifetime Educational Attainment? Evidence From Mexico.

Existing scholarship reveals important and competing influences of parental migration on children's educational trajectories. On the one hand, in the short term, left-behind children commonly take on additional housework and sometimes place less emphasis on education if they aspire to follow in their parents' migratory footsteps. On the other hand, parental migration often leads to monetary transfers (remittances), which reduces financial pressure on sending households and can strengthen educational aspirations among children left behind. Because previous studies examined these effects on children still completing their educations, the cumulative impact of parental migration on children's educational attainment remains uncertain. In this study, we use retrospective life history data from the Mexican Migration Project to link parental migrations occurring during childhood with children's educational attainment measured in adulthood. Using a novel counterfactual approach, we find that parental migration during childhood is associated with increased years of schooling and higher probabilities of completing lower-secondary school, entering upper-secondary school, and completing upper-secondary school. These associations were strongest among children whose parents did not complete primary school and those living in rural areas. Results from a placebo test suggest that these positive associations cannot be attributed to unobserved household characteristics related to parental migration, which supports a causal interpretation of our main findings. Thus, our analysis suggests that, on average, and particularly among more-disadvantaged households, the long-term educational benefits associated with parental migration outweigh short-term disruptions and strain associated with parental absence.

Promoting Community Awareness of Lung Cancer Screening Among Disparate Populations: Results of the cancer-Community Awareness Access Research and Education Project.

BACKGROUND: Lung cancer is the no. 1 cause of cancer death in the United States. Racial/ethnic minority and medically underserved populations suffer higher mortality than whites. Early detection through uptake of low-dose computed tomography (LDCT) among screening-eligible adults may mitigate high mortality. However, nearly 5 years since the publication of the US Preventive Services Task Force lung cancer screening guideline, population awareness of LDCT is low, and only 4% of screening-eligible adults have undergone screening. OBJECTIVE: This project used an education intervention to change participants' knowledge, attitudes, and beliefs about cancer risk factors and lung cancer and to connect eligible individuals to LDCT screening and tobacco cessation services. INTERVENTIONS/METHODS: Community-engaged strategies were used to deliver a 4-week educational program in 13 community sites. Trained community health workers delivered the intervention. The intervention was guided by the Health Belief Model. Data were collected by survey to 481 participants; 93% were African American, the majority was female (73.1%), mean age was 58.3 (SD, 10.9) years. RESULTS: There were knowledge increase regarding lung cancer screening (P = .001), a significant decrease in Perceived Severity and Perceived Barriers subscales (P = .001), and an overall increase in response to Perceived Benefits of lung cancer screening and Self-efficacy (P = .001). Fifty-four percent of tobacco users engaged in cessation; 38% of screening-eligible participants underwent LDCT screening. CONCLUSIONS: Community health workers are effective in increasing awareness of lung cancer screening and affecting behavior change among disparate populations. IMPLICATIONS FOR PRACTICE: Community health workers may have a clinical role in LDCT shared decision making.

Keystone Flaps: Physiology, Types, and Clinical Applications.

The keystone perforator flap (KPF) was first introduced in 2003 by Behan et al for use in reconstruction after skin cancer excision. Since its initial description, KPF use has been expanded to complex defects of various etiologies and disorders throughout the body. At its most basic, the KPF is a perforator-type flap designed with a 1:1 flap-to-defect width ratio. Keystone perforator flaps are specifically raised on pedicles arising from musculocutaneous or fasciocutaneous perforator vessels. Major advantages of the KPF derive from the maintenance of perforator vascular territories, perforosomes, permitting increased flap viability. In turn, this allows for more aggressive undermining in sites away from perforators when greater skin mobilization is necessary. Furthermore, the KPF is relatively easy to perform leading to shorter operative times and no postoperative monitoring period. There are basically 4 different types of keystone flaps in order of increasing undermining and disturbance of underlying fascia. These different classifications of KPFs may be used in different anatomical locations over the entire body based on skin laxity and defect size/depth. Numerous advancements and modifications have been documented adapting the KPF to specific conditions, including myelomeningoceles, and scrotal and lower eyelid defects. The purpose of this article is to provide an organized review of the KPF with emphasis on different classifications, applications, and limitations as well as an overview of the surgical technique. We have additionally included a discussion on KPF physiology and review of current literature.

Design of a Community-Based Lung Cancer Education, Prevention, and Screening Program.

Uptake of low-dose computed tomography (LDCT) for lung cancer screening is extremely low. Efforts to promote screening are warranted, especially among disparate groups such as racial/ethnic minorities and those of lower socioeconomic status. This article describes the design and implementation strategies of the ongoing cancer-Community Awareness Access Research and Education (c-CARE) program. The purpose of c-CARE is to increase community awareness of lung cancer screening through education. Community health workers were trained to implement the intervention in 12 community sites. The Health Belief Model guided the evaluation and intervention development methods. Aims include changing participants' knowledge, attitude, and beliefs related to lung cancer and increasing lung cancer early detection and prevention behaviors by identifying and connecting high-risk and/or nicotine-dependent individuals to LDCT screening and/or tobacco cessation services. If effective, these methods could model increased dissemination to other high-risk communities.

Cost-effectiveness of a faith-based lifestyle intervention for diabetes prevention among African Americans: A within-trial analysis.

AIMS: We assessed costs and cost-effectiveness of implementing Fit Body and Soul (FBAS), a church-based 18-session lifestyle education intervention for African Americans. METHODS: We calculated incremental cost-effectiveness ratios (ICER) using data from a cluster randomized controlled trial comparing FBAS with health education (HE) among 604 overweight participants in 20 churches. The ICER was the adjusted difference in costs to deliver FBAS versus HE over the difference in weight change (kilograms [kg]) at one-year follow-up. Costs included those incurred for participant identification and program implementation. We fitted linear mixed-effects regression models, accounting for clustering of participants within churches and for age, sex, and educational attainment. We repeated these analyses for secondary outcomes (waist circumference [cm], physical activity [MET], glucose, blood pressure, and quality of life). RESULTS: Per-person intervention cost of FBAS was $50.39 more than HE ($442.22 vs. $391.83 per-person), and adjusted differences in weight change (1.9 kg [95% CI: 1.0 to 2.8]) and waist circumference (2.4 cm [95% CI: 1.3 to 3.4]) were both significant. FBAS did not result in statistically significant differences in physical activity, glucose, blood pressures, or quality of life. We estimated that compared to HE, FBAS costs an additional $26.52 per kg weight lost and $21.00 per cm reduction in waist circumference. CONCLUSIONS: For a modest increase in cost, FBAS led to greater weight and waist reductions among African Americans in a church setting. ClinicalTrials.gov Identifier NCT01730196.

Demographic, psychosocial, and behavioral associations with cancer screening among a homeless population.

BACKGROUND: Although cancer incidence and mortality is declining, cancer remains among the leading causes of death in the United States. Research shows that cancer morbidity and mortality can be reduced by early detection. Yet, both cancer risks and screening behavior remain understudied in the homeless population. METHODS: Researchers conducted a cross-sectional survey of homeless individuals (n = 201). The analysis describes the demographic, psychosocial, and behavioral associations with cancer screenings and knowledge of the lung cancer screening recommendation. RESULTS: Participants' mean age was 51.7 years (SD 13.6); the group was largely African American (77.3%) and male (67.9%). Among women, the breast and cervical cancer screening rates were 46.5% and 85.1%. Among men the prostate cancer screening rate was 34.2%. Among all participants, the colon cancer screening rate was 44%. Cancer risk behaviors were high. Lung cancer screening knowledge was low (23.0%). Some cancer screening behaviors were associated with age, income, health status, obesity, tobacco use, and physical activity. DISCUSSION: Despite higher cancer risk behaviors, knowledge and general participation rates for cancer screenings were below national benchmarks. CONCLUSION: To improve cancer survival among disparate populations, sustained community outreach is necessary to increase awareness of screening recommendations, identify high-risk individuals, and navigate them to resources.

A DYNAMIC MODEL OF SELF-EMPLOYMENT AND SOCIOECONOMIC MOBILITY AMONG RETURN MIGRANTS: THE CASE OF URBAN MEXICO.

Return migrants engage in high rates of self-employment, which scholars commonly attribute to the accumulation of financial and human capital while working abroad. Central to this scholarship is the assumption that self-employment is positive and leads to upward economic mobility among return migrants. This scholarship is limited, however, because it relies on large surveys and cross-sectional census data that treat self-employment as a single uni-dimensional status measured at one point in time. To improve conceptualization and measurement of self- employment, we engage three bodies of research that have thus far had little cross-fertilization: the literature on work and self-employment in Latin America, the scholarship on return migration and self-employment, and developments in economic theories of international migration. Drawing on results from the first longitudinal analysis of the labor market trajectories of Mexican return migrants in a large urban area in central Mexico, we identify three types of self-employment - survivalist, temporary, and prosperous. To explain these divergent self-employment pathways, we draw on biographical narratives and identify two sets of mechanisms - human capital formation and life-course stage. Overall, our investigation of self-employment types suggests a complex relationship between international migration experiences and the labor market mobility of return migrants which cannot be understood without taking into consideration migrants' social and economic circumstances before, during, and after migration. Consequently, our study yields insights into economic theories of international migration and provides direction for future research on return migration and labor market reintegration.

Percent weight reduction required to achieve minimal clinically important improvements in health-related quality of life among African Americans: A secondary analysis of the fit body and soul study.

OBJECTIVE: To calculate the percent weight reduction required to achieve minimal clinically important improvement (MCII) in health-related quality of life (HRQOL). DESIGN: Secondary data analysis from the longitudinal cohort of a single-blinded, cluster-randomized community trial to test the efficacy of the faith-based adaptation of the Diabetes Prevention Program. SETTING: African-American churches. PARTICIPANTS: This study included 472 congregants with a body mass index of ≥25 and fasting plasma glucose<126mg/dl. MAIN OUTCOME MEASURE: Percent weight reduction required to achieve the MCII in HRQOL measured by two instruments, SF-12 and EQ-5D, one year following baseline. ANALYSIS: The percent weight reduction required to achieve established MCII in SF-12 Physical Component Summary (PCS), SF-12 Mental Component Summary (MCS), and EQ-5D Health Status (HS) at one-year follow-up were calculated using fitted linear regression models. In addition to models for the total sample, we generated models, stratified by baseline BMI, PCS, and HS, to calculate the percent weight reduction required to achieve MCII in HRQOL for those most in need of weight reduction and those in need of improved HRQOL. RESULTS: The percent weight reduction was a significant predictor of improvement in the SF-12PCS and the EQ-5DHS but not SF-12MCS. To achieve a MCII in SF-12PCS and EQ-5DHS, 18% and 30% weight reductions were required, respectively. A smaller percent weight reduction was required when the baseline BMI was ≥40. CONCLUSIONS AND IMPLICATIONS: Improvements in HRQOL among African-American congregants seeking weight reduction required more than the 3-5% weight reduction associated with improvements in physical health.

Immediate Mood Scaler: Tracking Symptoms of Depression and Anxiety Using a Novel Mobile Mood Scale.

BACKGROUND: Mood disorders are dynamic disorders characterized by multimodal symptoms. Clinical assessment of symptoms is currently limited to relatively sparse, routine clinic visits, requiring retrospective recollection of symptoms present in the weeks preceding the visit. Novel advances in mobile tools now support ecological momentary assessment of mood, conducted frequently using mobile devices, outside the clinical setting. Such mood assessment may help circumvent problems associated with infrequent reporting and better characterize the dynamic presentation of mood symptoms, informing the delivery of novel treatment options. OBJECTIVES: The aim of our study was to validate the Immediate Mood Scaler (IMS), a newly developed, iPad-deliverable 22-item self-report tool designed to capture current mood states. METHODS: A total of 110 individuals completed standardized questionnaires (Patient Health Questionnaire, 9-item [PHQ-9]; generalized anxiety disorder, 7-Item [GAD-7]; and rumination scale) and IMS at baseline. Of the total, 56 completed at least one additional session of IMS, and 17 completed one additional administration of PHQ-9 and GAD-7. We conducted exploratory Principal Axis Factor Analysis to assess dimensionality of IMS, and computed zero-order correlations to investigate associations between IMS and standardized scales. Linear Mixed Model (LMM) was used to assess IMS stability across time and to test predictability of PHQ-9 and GAD-7 score by IMS. RESULTS: Strong correlations were found between standard mood scales and the IMS at baseline (r=.57-.59, P<.001). A factor analysis revealed a 12-item IMS ("IMS-12") with two factors: a "depression" factor and an "anxiety" factor. IMS-12 depression subscale was more strongly correlated with PHQ-9 than with GAD-7 (z=1.88, P=.03), but the reverse pattern was not found for IMS-12 anxiety subscale. IMS-12 showed less stability over time compared with PHQ-9 and GAD-7 (.65 vs .91), potentially reflecting more sensitivity to mood dynamics. In addition, IMS-12 ratings indicated that individuals with mild to moderate depression had greater mood fluctuations compared with individuals with severe depression (.42 vs .79; P=.04). Finally, IMS-12 significantly contributed to the prediction of subsequent PHQ-9 (beta=1.03, P=.02) and GAD-7 scores (beta =.93, P=.01). CONCLUSIONS: Collectively, these data suggest that the 12-item IMS (IMS-12) is a valid tool to assess momentary mood symptoms related to anxiety and depression. Although IMS-12 shows good correlation with standardized scales, it further captures mood fluctuations better and significantly adds to the prediction of the scales. Results are discussed in the context of providing continuous symptom quantification that may inform novel treatment options and support personalized treatment plans.

Community Trial of a Faith-Based Lifestyle Intervention to Prevent Diabetes Among African-Americans.

About 75% of African-Americans (AAs) ages 20 or older are overweight and nearly 50% are obese, but community-based programs to reduce diabetes risk in AAs are rare. Our objective was to reduce weight and fasting plasma glucose (FPG) and increase physical activity (PA) from baseline to week-12 and to month-12 among overweight AA parishioners through a faith-based adaptation of the Diabetes Prevention Program called Fit Body and Soul (FBAS). We conducted a single-blinded, cluster randomized, community trial in 20 AA churches enrolling 604 AAs, aged 20-64 years with BMI ≥ 25 kg/m(2) and without diabetes. The church (and their parishioners) was randomized to FBAS or health education (HE). FBAS participants had a significant difference in adjusted weight loss compared with those in HE (2.62 vs. 0.50 kg, p = 0.001) at 12-weeks and (2.39 vs. -0.465 kg, p = 0.005) at 12-months and were more likely (13%) than HE participants (3%) to achieve a 7% weight loss (p < 0.001) at 12-weeks and a 7% weight loss (19 vs. 8%, p < 0.001) at 12-months. There were no significant differences in FPG and PA between arms. Of the 15.2% of participants with baseline pre-diabetes, those in FBAS had, however, a significant decline in FPG (10.93 mg/dl) at 12-weeks compared with the 4.22 mg/dl increase in HE (p = 0.017), and these differences became larger at 12-months (FBAS, 12.38 mg/dl decrease; HE, 4.44 mg/dl increase) (p = 0.021). Our faith-based adaptation of the DPP led to a significant reduction in weight overall and in FPG among pre-diabetes participants. CLINICALTRIALS. GOV IDENTIFIER: NCT01730196.

Pathway to Weight Maintenance: A-Qualitative Study with Church Health Advisors to Assess Weight Loss Maintenance Program Needs Among African-Americans.

Nearly 50% of African-American adults are obese. Obesity is a known contributor to chronic diseases such as type 2 diabetes mellitus (type 2 DM). Short-term Diabetes Prevention Programs (DPPs) achieve short-term weight loss success, but weight regain is common. African-Americans, compared to Whites, are particularly challenged by weight maintenance. In collaboration with community health workers, translation scientists have delivered successful short-term DPPs in community settings, such as African-American churches. Evidence of the salient components of effective weight maintenance intervention is minimal, especially among African-Americans in churches, and there is no known research that specifically explores the insights of community health workers. We report findings from a qualitative study to identify the necessary components of a sustainable church-based weight maintenance program from the perspective of community health workers. Two main themes emerged: overemphasis of short-term goals and consistent support. These findings have relevancy for developing faith-based weight maintenance programs.

Reduction of 30-Day Preventable Pediatric Readmission Rates With Postdischarge Phone Calls Utilizing a Patient- and Family-Centered Care Approach.

INTRODUCTION: The purpose of this project was to evaluate the effectiveness of postdischarge phone calls on 30-day preventable readmission rates within the pediatric hospital setting. Because the unit of care identified was patients and their families, a patient- and family-centered care approach was used. METHOD: The project used an exploratory design and was conducted at a 154-bed pediatric hospital facility. A sample of 15 patients meeting project inclusion criteria was selected before and after the intervention, and medical records were reviewed to identify if a 30-day preventable readmission had occurred. RESULTS: Medical record review revealed four preintervention readmissions, providing an overall preintervention readmission rate of 26%. Only one readmission was discovered after the intervention, yielding an overall postintervention readmission rate of 6%. DISCUSSION: The sample size was not large enough to show statistical significance, but clinical significance was seen, with readmission rates for the project target population decreasing below the rates recorded in 2012.

Comparison of central line-associated bloodstream infection rates when changing to a zero fluid displacement intravenous needleless connector in acute care settings.

This was a multicenter, quasiexperimental, 140-month, acute care study comparing central line-associated bloodstream infection rates associated with positive or negative intravenous connectors to a zero fluid displacement connector. A decrease in central line-associated bloodstream infections was found after changing from either negative or positive intravenous connectors to the zero fluid displacement connector (P = .004) with total cost savings of over $3 million.

Patients satisfaction with warfarin and willingness to switch to dabigatran: a patient survey.

Warfarin is an anticoagulant medication that is challenging to manage. Dabigatran has been approved by the FDA for stroke and systemic embolism prevention in non-valvular atrial fibrillation as an alternative to warfarin. Dabigatran does not require routine monitoring, has an established dose, and lacks many of the drug, herbal, and food interactions that afflict warfarin. To evaluate patients' satisfaction with their current warfarin treatment and their opinion on switching to a newly marketed medication (dabigatran) through a brief survey. Two separate surveys were administered to (1) evaluate the patients' opinion of their warfarin therapy and (2) evaluate their thoughts on switching to a newer anticoagulant. Responses were recorded on a rating scale of 1-5; 1 being the least and 5 being the highest. Study was conducted at the Georgia Regents Health System (GRHS) pharmacy-based anticoagulation clinic. Two hundred sixty patients on warfarin treatment were enrolled. Patients expressed high satisfaction with warfarin treatment (4.7 ± 0.78). However, a vast majority of the patients were willing to switch to an agent that: requires less frequent follow-up visits (3.9 ± 1.35); lacks interaction with food and/or beverage (4.1 ± 1.25); is as efficacious as warfarin (3.7 ± 1.38). Patients expressed that out-of-pocket cost would be a major barrier to switch to this new medication (1.3 ± 0.58). Patients are satisfied with their warfarin treatment but willing to consider a new anticoagulant. Cost was highlighted as the most significant barrier. Efficacy, dietary freedom and less frequent visits are the major factors affecting the patients' decision.

Comparison of audio vs. written feedback on clinical assignments of nursing students.

AIM: This pilot study explored using audio recordings as method of feedback for weekly clinical assignments of nursing students. BACKGROUND: Feedback that provides students with insight into their performance is an essential component of nursing education. Audio methods have been used to communicate feedback on written assignments in other disciplines, but this method has not been reported in the nursing literature. METHOD: A survey and VARK questionnaire were completed by eight nursing students. Each student had randomly received written and audio feedback during an eight-week period. RESULTS: There were no differences between written and audio methods. Students perceived audio as the most personal, easy to understand, and positive method. Only one student expressed a preference for written feedback.There was no difference in instructor time. CONCLUSION: Audio feedback is an innovative method of feedback for clinical assignments of 'Net Generation' nursing students.

Design of a cluster-randomized controlled trial of a diabetes prevention program within African-American churches: The Fit Body and Soul study.

Evidence from varied community settings has shown that the Group Lifestyle Balance (GLB) Program and other adaptations of the Diabetes Prevention Program (DPP) intervention are effective in lowering diabetes risk. Most DPP data originated from studies of pre-diabetic whites, with only sparse evidence of the effect of DPP in African Americans (AAs) in community settings. This paper describes the design, methods, baseline characteristics and cost effective measures, of a single-blinded, cluster-randomized trial of a faith-based adaptation of the GLB program, Fit Body and Soul (FBAS). The major aims are to test efficacy and cost utility of FBAS in twenty AA churches. Randomization occurred at the church level and 604 AA overweight/obese (BMI≥25kg/m(2)) adults with fasting plasma glucose range from normal to pre-diabetic received either FBAS or a health-education comparison program. FBAS is a group-based, multi-level intervention delivered by trained church health advisors (health professionals from within the church), with the goal of ≥7% weight loss, achieved through increasing physical activity, healthy eating and behavior modification. The primary outcome is weight change at 12weeks post intervention. Secondary outcomes include hemoglobin A1C, fasting plasma glucose, waist circumference, blood pressure, physical activity level, quality of life measures, and cost-effectiveness. FBAS is the largest known cohort of AAs enrolled in a faith-based DPP translation. Reliance on health professionals from within the church for program implementation and the cost analysis are unique aspects of this trial. The design provides a model for faith-based DPPs and holds promise for program sustainability and widespread dissemination.