Preventing diabetes in obese Latino youth with prediabetes: a study protocol for a randomized controlled trial.

BACKGROUND: Obese Latino adolescents are disproportionately impacted by insulin resistance and type 2 diabetes. Prediabetes is an intermediate stage in the pathogenesis of type 2 diabetes and represents a critical opportunity for intervention. However, to date, no diabetes prevention studies have been conducted in obese Latino youth with prediabetes, a highly vulnerable and underserved group. Therefore, we propose a randomized-controlled trial to test the short-term (6-month) and long-term (12-month) efficacy of a culturally-grounded, lifestyle intervention, as compared to usual care, for improving glucose tolerance and reducing diabetes risk in 120 obese Latino adolescents with prediabetes. METHODS: Participants will be randomized to a lifestyle intervention or usual care group. Participants in the intervention group will attend weekly nutrition and wellness sessions and physical activity sessions twice a week for six months, followed by three months of booster sessions. The overall approach of the intervention is framed within a multilevel Ecodevelopmental model that leverages community, family, peer, and individual factors during the critical transition period of adolescence. The intervention is also guided by Social Cognitive Theory and employs key behavioral modification strategies to enhance self-efficacy and foster social support for making and sustaining healthy behavior changes. We will test intervention effects on quality of life, explore the potential mediating effects of changes in body composition, total, regional, and organ fat on improving glucose tolerance and increasing insulin sensitivity, and estimate the initial incremental cost effectiveness of the intervention as compared with usual care for improving glucose tolerance. DISCUSSION: The proposed trial builds upon extant collaborations of a transdisciplinary team of investigators working in concert with local community agencies to address critical gaps in how diabetes prevention interventions for obese Latino youth are developed, implemented and evaluated. This innovative approach is an essential step in the development of scalable, cost-effective, solution oriented programs to prevent type 2 diabetes in this and other populations of high-risk youth. TRIAL REGISTRATION: NCT02615353, registered on June 8, 2016.

Examining 24-Hour Activity and Sleep Behaviors and Related Determinants in Latino Adolescents and Young Adults With Obesity.

Background. Few studies have examined 24-hour activity and sleep behaviors and their contribution to type 2 diabetes (T2D) in Latino adolescents and young adults with obesity. Aim. This study included quantitative data on T2D risk and 24-hour activity and sleep behaviors and qualitative data on individual, social, and environmental behavioral determinants. Method. A 7 day, 24-hour, wrist-worn accelerometer protocol assessed moderate-to-vigorous physical activity (PA), sedentary behaviors (SB), sleep, and sleep regularity, in adolescents (N = 38; 12-16 years) and young adults (N = 22; 18-22 years). T2D-related outcomes included adiposity (BMI, BF%, waist circumference), fasting, and 2-hour glucose. A subsample of participants (N = 16 adolescents, N = 15 young adults) completed interviews to identify behavioral determinants. Results. High levels of PA were observed among adolescents (M = 103.8 ± 67.5 minutes/day) and young adults (M = 96.8 ± 78.8 minutes/day) as well as high levels of SB across both age groups (≥10 hours/day). Sleep regularity was negatively associated with adiposity (all ps < .05) in both age groups as well as fasting and 2-hour glucose in young adults (all ps < .05). Social support was associated with PA in both age groups as well as SB in younger youth. Auditory noises, lights, and safety inhibited sleep in both age groups. Conclusion. PA is critical for disease reduction, yet reducing SB and improving sleep are also important targets for reducing T2D risk in Hispanic adolescents and young adults. Future health promotion and disease prevention strategies should leverage qualitative findings regarding behavioral determinants.

Mujeres en accion: design and baseline data.

The majority of programs designed to promote physical activity in older Hispanic women includes few innovative theory-based interventions that address cultural relevant strategies. The purpose of this report is to describe the design and baseline data for Mujeres en Accion, a physical activity intervention to increase regular physical activity, and cardiovascular health outcomes among older Hispanic women. Mujeres en Accion [Women in Action for Health], a 12 month randomized controlled trial to evaluate the effectiveness of a social support physical activity intervention in midlife and older Hispanic women. This study tests an innovative intervention, Mujeres en Accion, and includes the use of a theory-driven approach to intervention, explores social support as a theoretical mediating variable, use of a Promotora model and a Community Advisory group to incorporate cultural and social approaches and resources, and use of objective measures of physical activity in Hispanic women.

Perceptions of Family-Level Social Factors That Influence Health Behaviors in Latinx Adolescents and Young Adults at High Risk for Type 2 Diabetes.

Given that health behaviors occur within the context of familial social relationships, a deeper understanding of social factors that influence health behaviors in Latinx families is needed to develop more effective diabetes prevention programming. This qualitative study identified perceived family-level social factors that influence health behaviors in Latinx adolescents (12-16 years; N = 16) and young adults (18-24 years; N = 15) with obesity and explored differences in perceptions across sex and age. Participants completed an in-depth interview that was recorded, transcribed, and coded using thematic content analysis. Emergent themes central to health behaviors included: perceived parental roles and responsibilities, perceived family social support for health behaviors, and familial social relationships. Mom's role as primary caregiver and dad's role as a hard worker were seen as barriers to engaging in health behaviors among adolescent females and young adults, males and females. Adolescents perceived receiving more support compared to young adults and males perceived receiving more support compared to females. Health behaviors in both age groups were shaped through early familial social interactions around physical activity. These insights suggest that traditional gender roles, social support, and social interaction around health behaviors are critical components for family-based diabetes prevention programs in high-risk Latinx youth and young adults.

Theoretical Mediators of Diabetes Risk and Quality of Life Following a Diabetes Prevention Program for Latino Youth With Obesity.

PURPOSE: This study tested self-efficacy and social support for activity and dietary changes as mediators of changes in type 2 diabetes related outcomes following a lifestyle intervention among Latino youth. SETTING AND INTERVENTION: Latino adolescents (14-16 years) with obesity (BMI% = 98.1 ± 1.4) were randomized to a 3-month intervention (n = 67) that fostered self-efficacy and social support through weekly, family-centered sessions or a comparison condition (n = 69). MEASURES: Primary outcomes included insulin sensitivity and weight specific quality of life. Mediators included self-efficacy, friend, and family social support for health behaviors. Data was collected at baseline, 3-months, 6-months, and 12-months. ANALYSIS: Sequential path analysis was used to examine mediators as mechanisms by which the intervention influenced primary outcomes. RESULTS: The intervention had a direct effect on family (ß = 0.33, P < .01) and friend social support (ß = 0.22, P < .001) immediately following the intervention (3-months). Increased family social support mediated the intervention's effect on self-efficacy at 6-months (ß = 0.09, P < .01). However, social support and self-efficacy did not mediate long-term changes in primary outcomes (P > .05) at 12-months. CONCLUSIONS: Family social support may improve self-efficacy for health behaviors in high-risk Latino youth, highlighting the important role of family diabetes prevention. Fostering family social support is a critical intervention target and more research is needed to understand family-level factors that have the potential to lead to long-term metabolic and psychosocial outcome in vulnerable youth.

Yields and costs of recruitment methods with participant phenotypic characteristics for a diabetes prevention research study in an underrepresented pediatric population.

BACKGROUND/AIMS: Prediabetes and diabetes disproportionately impact Latino youth, yet few diabetes prevention programs have prioritized inclusion of this underrepresented population. This report describes the recruitment process, yields, associated costs, and phenotypic characteristics of Latino youth with obesity and prediabetes enrolled in a randomized controlled diabetes prevention study in the USA. METHODS: Recruitment efforts included referrals from clinics, community outlets, local media, and word of mouth with the goal of enrolling 120 Latino adolescents aged 12-16 with obesity (BMI > 95th percentile) and prediabetes. Prediabetes eligibility was determined by any of the following: HbA1c between 5.7 and 6.5%, fasting glucose between 100 and 125 mg/dL, or a 2-h glucose between 120 and 199 mg/dL following a 75-g oral glucose tolerance test (OGTT), but not meeting any of the diagnostic criteria for diabetes. Eligible participants were randomized 2:1 to either a 6-month community-based lifestyle intervention that included group nutrition and health education classes (1 day/week) and group exercise classes (2 days/week) or usual care control arm. Recruitment yields were determined by review of referral source in the study screening database. Recruitment costs were determined by an after-the-fact financial review of actual and in-kind costs. Participant phenotypic characteristics (i.e., demographics, anthropometrics, and biochemical data) were compared by recruitment strategy using a one-way ANOVA. RESULTS: Recruitment efforts covered 160 mile2 (414 km2) across 26 ZIP codes (postcode) in the Phoenix Metropolitan Area and yielded 655 referrals from clinics (n = 344), community (n = 143), media (n = 137), and word-of-mouth (n = 31). From this pool, 26% (n = 167) did not meet general, pre-screening eligibility criteria; 29% (n = 187) declined participation; and 10% (n = 64) were unable to be contacted. A total of 237 youth were invited to the clinical research unit to determine final eligibility. Following the OGTT, 52% (n = 122) met prediabetes criteria and 117 were subsequently randomized. Clinical recruitment yielded the highest number of referrals (53%; n = 344) while word-of-mouth yielded the highest proportion (35%; n = 11) of randomized participants per referred youth. There were no significant differences in anthropometric or biochemical measures among youth by recruitment strategy. Based upon final enrollment numbers, community recruitment was the costliest approach ($486/randomized participant) followed by clinical ($248/randomized participant) and media ($236/randomized participant). CONCLUSIONS: The ability to meet enrollment goals for a clinical trial of an underrepresented population required multiple recruitment strategies. Although strategies vary in yields and costs, it appears they produce similar phenotypical risk profiles of eligible youth. TRIAL REGISTRATION: ClinicalTrials.gov NCT02615353 . Registered on 26 November 2015.

Decreased GlycA after lifestyle intervention among obese, prediabetic adolescent Latinos.

BACKGROUND: Obese youth with prediabetes are at increased risk for premature morbidity and mortality through multiple mechanisms, including increased systemic inflammation. GlycA is a novel measure of systemic inflammation that predicts type II diabetes, cardiovascular events, and all-cause mortality in adults. OBJECTIVE: The purpose of the present study was to examine changes in GlycA after lifestyle intervention among obese, prediabetic Latino youth. METHODS: Obese, prediabetic Latino youth (n = 27; 15.5 ± 1.1 years, 13 males/14 females) completed a 12-week lifestyle intervention that included weekly nutrition education and 3 d/wk of moderate to vigorous physical activity. Prediabetes was characterized by an expanded definition of impaired glucose tolerance, using 2-hour glucose ≥120 mg/dL after an oral glucose tolerance test. GlycA was assessed at baseline and 12 weeks using nuclear magnetic resonance spectroscopy. RESULTS: After the lifestyle intervention, GlycA was significantly reduced (445.3 ± 51.3 µmol/L to 419.0 ± 50.0 µmol/L, P = .01) (mean ± standard deviation). Additional improvements were observed in multiple cardiovascular risk factors, including body mass index (BMI; 34.8 ± 5.0 kg/m2 to 34.0 ± 5.1 kg/m2, P < .001), total cholesterol (154.1 ± 30.3 mg/dL to 143.3 ± 29.1 mg/dL, P = .003), and 2-hour glucose (141.0 ± 13.2 mg/dL to 115.9 ± 31.4 mg/dL, P < .001). Decreases in GlycA were associated with decreases in 2-hour glucose (r = 0.49, P = .008) and BMI (r = 0.41, P = .03). CONCLUSION: These data are consistent with the hypothesis that lifestyle intervention might improve GlycA levels in obese, prediabetic adolescent Latinos, but randomized trial evidence is needed. Healthy lifestyle modifications among high-risk youth may decrease future risk of cardiometabolic disease through reducing systemic inflammation, in addition to improving traditional cardiovascular risk factors.

Effects of a Community-Based Diabetes Prevention Program for Latino Youth with Obesity: A Randomized Controlled Trial.

OBJECTIVE: This study examined the short- and long-term effects of a community-based lifestyle intervention among Latino youth with obesity. METHODS: Latino adolescents (14-16 years old) were randomized to a 3-month lifestyle intervention (n = 67) or comparison control (n = 69) and followed for 12 months. The intervention included weekly nutrition and health classes delivered to groups of families and exercise sessions (3 days/week) delivered to groups of adolescents. Comparison youth received laboratory results and general health information. Primary outcomes included insulin sensitivity and weight-specific quality of life (QoL) with secondary outcomes of BMI percentile (BMI%), waist circumference, and percent body fat. RESULTS: At 3 months, youth in the intervention group exhibited significant increases in insulin sensitivity (P < 0.05) and weight-specific QoL (P < 0.001), as well as reductions in BMI%, waist circumference, and percent body fat compared with controls. Increases in weight-specific QoL and reductions in BMI% and percent body fat remained significant at 12 months (P < 0.001), while changes in insulin sensitivity did not. In a subsample of youth with prediabetes at baseline, insulin sensitivity (P = 0.01), weight-specific QoL (P < 0.001), and BMI% (P < 0.001) significantly improved at 3 months. CONCLUSIONS: Lifestyle intervention can improve cardiometabolic and psychosocial health in a vulnerable population of Latino adolescents at high risk for developing type 2 diabetes.

Development of a Self-Rated Mixed Methods Skills Assessment: The National Institutes of Health Mixed Methods Research Training Program for the Health Sciences.

INTRODUCTION: Demand for training in mixed methods is high, with little research on faculty development or assessment in mixed methods. We describe the development of a self-rated mixed methods skills assessment and provide validity evidence. The instrument taps six research domains: "Research question," "Design/approach," "Sampling," "Data collection," "Analysis," and "Dissemination." Respondents are asked to rate their ability to define or explain concepts of mixed methods under each domain, their ability to apply the concepts to problems, and the extent to which they need to improve. METHODS: We administered the questionnaire to 145 faculty and students using an internet survey. We analyzed descriptive statistics and performance characteristics of the questionnaire using the Cronbach alpha to assess reliability and an analysis of variance that compared a mixed methods experience index with assessment scores to assess criterion relatedness. RESULTS: Internal consistency reliability was high for the total set of items (0.95) and adequate (≥0.71) for all but one subscale. Consistent with establishing criterion validity, respondents who had more professional experiences with mixed methods (eg, published a mixed methods article) rated themselves as more skilled, which was statistically significant across the research domains. DISCUSSION: This self-rated mixed methods assessment instrument may be a useful tool to assess skills in mixed methods for training programs. It can be applied widely at the graduate and faculty level. For the learner, assessment may lead to enhanced motivation to learn and training focused on self-identified needs. For faculty, the assessment may improve curriculum and course content planning.

Cultural adaptations of behavioral health interventions: a progress report.

OBJECTIVE: To reduce health disparities, behavioral health interventions must reach subcultural groups and demonstrate effectiveness in improving their health behaviors and outcomes. One approach to developing such health interventions is to culturally adapt original evidence-based interventions. The goals of the article are to (a) describe consensus on the stages involved in developing cultural adaptations, (b) identify common elements in cultural adaptations, (c) examine evidence on the effectiveness of culturally enhanced interventions for various health conditions, and (d) pose questions for future research. METHOD: Influential literature from the past decade was examined to identify points of consensus. RESULTS: There is agreement that cultural adaptation can be organized into 5 stages: information gathering, preliminary design, preliminary testing, refinement, and final trial. With few exceptions, reviews of several health conditions (e.g., AIDS, asthma, diabetes) concluded that culturally enhanced interventions are more effective in improving health outcomes than usual care or other control conditions. CONCLUSIONS: Progress has been made in establishing methods for conducting cultural adaptations and providing evidence of their effectiveness. Future research should include evaluations of cultural adaptations developed in stages, tests to determine the effectiveness of cultural adaptations relative to the original versions, and studies that advance our understanding of cultural constructs' contributions to intervention engagement and efficacy.

Participation and program outcomes in a church-based cancer prevention program for Hispanic women.

This study examined program attendance and related outcomes for Compañeros en la Salud, a church-based culturally focused health promotion program specifically designed for low-acculturated, low-income Hispanic women. In this church-based study, the cancer prevention intervention was the major intervention group, and its effects were compared with a noncancer-oriented family mental health group. The goal of the present study was to identity predictors of program attendance and increases in cancer prevention knowledge and behaviors. Lower levels of acculturation level and greater overall church attendance were predictive of program attendance for Hispanic women in the cancer prevention component. Also, attendance in the cancer intervention component of the Compañeros en la Salud program was predictive of posttest cancer prevention knowledge. By contrast, higher acculturation level was a significant predictor of having had a clinical breast exam at posttest. Similarly, younger age and lower fear of cancer were predictive of having had a pap smear at posttest. Finally, pretest cancer prevention knowledge was a significant predictor of mammography screening for women ages 40 and over. These results offer implications for the development of culturally tailored cancer prevention programs for Hispanic women.