Preventing diabetes in Latino families: A protocol for a randomized control trial.

BACKGROUND: Latino families are disproportionately affected by type 2 diabetes (T2D) and lifestyle intervention is the first-line approach for preventing T2D. The purpose of this study is to test the efficacy of a culturally-grounded lifestyle intervention that prioritizes health promotion and diabetes prevention for Latino families. The intervention is guided by a novel Family Diabetes Prevention Model, leveraging the family processes of engagement, empowerment, resilience, and cohesion to orient the family system towards health. METHOD: Latino families (N = 132) will be recruited and assessed for glucose tolerance as measured by an Oral Glucose Tolerance Test (OGTT) and General and Weight-Specific Quality of Life (QoL) at baseline, four months, and 12 months. All members of the household age 10 and over will be invited to participate. Families will be randomized to the intervention group or a control group (2:1). The 16-week intervention includes weekly nutrition and wellness classes delivered by bilingual, bicultural Registered Dietitians and community health educators at a local YMCA along with two days/week of supervised physical activity classes and a third day of unsupervised physical activity. Control families will meet with a physician and a Registered Dietitian to discuss the results of their metabolic testing and recommend lifestyle changes. We will test the efficacy of a family-focused diabetes prevention intervention for improving glucose tolerance and increasing QoL and test for mediators and moderators of long-term changes. CONCLUSION: This study will provide much needed data on the efficacy of a family-focused Diabetes Prevention Program among high-risk Latino families.

Effects of a Diabetes Prevention Program on Type 2 Diabetes Risk Factors and Quality of Life Among Latino Youths With Prediabetes: A Randomized Clinical Trial.

Importance: Latino youths are disproportionately impacted by prediabetes and type 2 diabetes (T2D). Lifestyle intervention is the first-line approach for preventing or delaying T2D among adults with prediabetes. Objective: To assess the efficacy of a diabetes prevention program among Latino youths aged 12 to 16 years with prediabetes. Design, Setting, and Participants: This 2-group parallel randomized clinical trial with 2:1 randomization assessed a lifestyle intervention against usual care among Latino youths with prediabetes and obesity with 6- and 12-month follow-up. The study was conducted at YMCA facilities in Phoenix, Arizona from May 2016 to March 2020. Intervention: Participants were randomized to lifestyle intervention (INT) or usual care control (UCC). The 6-month INT included 1 d/wk of nutrition and health education and 3 d/wk of physical activity. UCC included 2 visits with a pediatric endocrinologist and a bilingual, bicultural registered dietitian to discuss diabetes risks and healthy lifestyle changes. Main Outcomes and Measures: Insulin sensitivity, glucose tolerance, and weight-specific quality of life (YQOL-W) at 6- and 12-month follow-up. Results: A total of 117 Latino youths (mean [SD] age, 14 [1] years; 47 [40.1%] girls) were included in the analysis. Overall, 79 were randomized to INT and 38 to UCC. At 6 months, the INT led to significant decreases in mean (SE) 2-hour glucose (baseline: 144 [3] mg/dL; 6 months: 132 [3] mg/dL; P = .002) and increases in mean (SE) insulin sensitivity (baseline: 1.9 [0.2]; 6 months: 2.6 [0.3]; P = .001) and YQOL-W (baseline: 75 [2]; 6 months: 80 [2]; P = .006), but these changes were not significantly different from UCC (2-hour glucose: mean difference, -7.2 mg/dL; 95% CI, -19.7 to 5.3 mg/dL; P for interaction = .26; insulin sensitivity: mean difference, 0.1; 95% CI, -0.7 to 0.9; P for interaction = .79; YQOL-W: mean difference, 6.3; 95% CI, -1.1 to 13.7; P for interaction = .10, respectively). Both INT (mean [SE], -15 mg/dL [4.9]; P = .002) and UCC (mean [SE], -15 mg/dL [5.4]; P = .005) had significant 12-month reductions in 2-hour glucose that did not differ significantly from each other (mean difference, -0.3; 95% CI, -14.5 to 14.1 mg/dL; P for interaction = .97). At 12 months, changes in mean (SE) insulin sensitivity in INT (baseline: 1.9 [0.2]; 12 months: 2.3 [0.2]; P = .06) and UCC (baseline: 1.9 [0.3]; 12 months: 2.0 [0.2]; P = .70) were not significantly different (mean difference, 0.3; 95% CI, -0.4 to 1.0; P for interaction = .37). At 12 months, YQOL-W was significantly increased in INT (basline: 75 [2]; 12 months: 82 [2]; P < .001) vs UCC (mean difference, 8.5; 95% CI, 0.8 to 16.2; P for interaction = .03). Conclusions and Relevance: In this randomized clinical trial, both INT and UCC led to similar changes in T2D risk factors among Latino youths with diabetes; however, YQOL-W was improved in INT compared with UCC. Diabetes prevention interventions that are effective in adults also appeared to be effective in high risk youths. Trial Registration: ClinicalTrials.gov Identifier: NCT02615353.

¡Viva Maryvale!: A Multilevel, Multisector Model to Community-Based Diabetes Prevention.

INTRODUCTION: Latino communities are disproportionately affected by type 2 diabetes and experience disparities in access to diabetes prevention programs. The purpose of this study was to test the preliminary efficacy of a culturally grounded, diabetes prevention program for high-risk Latino families delivered through an integrated research-practice partnership. STUDY DESIGN: The integrated research-practice partnership was established in a predominantly Latino community and consisted of a Federally Qualified Health Center, a YMCA, an accredited diabetes education program, and an academic research center. Data were collected and analyzed from 2015 to 2018. SETTING/PARTICIPANTS: Latino families consisting of a parent with an obese child between age 8 and 12 years. INTERVENTION: The 12-week lifestyle intervention included nutrition education and behavioral skills training (60 minutes, once/week) and physical activity classes (60 minutes, three times/week) delivered at a YMCA. MAIN OUTCOME MEASURES: Outcomes included measures of adiposity (BMI, waist circumference, and body fat); HbA1c; and weight-specific quality of life. RESULTS: Over the course of the 2-year project period, 58 families (parents n=59, children n=68) were enrolled with 36% of parents and 29% of children meeting the criteria for prediabetes at baseline. Feasibility and acceptability were high, with 83% of enrolled families completing the program, 91% of the intervention sessions attended, and 100% of families stating they would recommend the program. The intervention led to significant decreases in percentage body fat among parents (46.4% [SD=10.8] to 43.5% [SD=10.5], p=0.001) as well as children (43.1% [SD=8.0] to 41.8% [SD=7.2], p=0.03). Additionally, HbA1c was significantly reduced in parents (5.6% [SD=0.4] to 5.5% [SD=0.3], p=0.03), and remained stable in children (5.5% [SD=0.3] vs 5.5% [SD=0.3], p>0.05). Significant improvements in quality of life were reported in parents (64.6 [SD=15.8] to 71.0 [SD=13.7], p=0.001) and children (69.7 [SD=15.8] to 72.6 [SD=13.7], p=0.05). CONCLUSIONS: These findings support the preliminary efficacy of an integrated research-practice partnership to meet the diabetes prevention needs of high-risk Latino families within a vulnerable community.