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

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Olson reported receiving personal fees from Rhythm Pharmaceuticals outside the submitted work. Dr Ayers reported receiving grants from the National Institute Diabetes and Digestive and Kidney Diseases during the conduct of the study. Dr Patrick reported receiving personal fees from Grail, Bristol Myers Squibb, and Allakos as well as grants from the National Institutes of Health outside the submitted work. Dr Shaibi reported receiving grants from the National Institutes of Health during the conduct of the study and personal fees from Phoenix Children’s Hospital (PCH) for research consultation, which has been disclosed to Arizona State University, outside the submitted work. PCH participated in the research resulting in this publication. No other disclosures were reported.

Figures

Figure 1.. Study Flow Diagram

BMI indicates body mass index; INT, lifestyle intervention; UCC, usual care control. aParticipants could be excluded for more than 1 reason.

Figure 2.. Changes in 2-Hour Glucose, Insulin Sensitivity, and Weight-Specific Quality of Life (QoL) Between Lifestyle Intervention (INT) and Usual Care Control (UCC)

T1 indicates baseline; T2, 6 months; and T3, 12 months. To convert glucose to millimoles per liter, multiply by 0.0555; insulin to picomoles per liter, multiply by 6.945.