Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix.
Division of Pediatric Endocrinology and Diabetes, Phoenix Children's Hospital, Phoenix, Arizona.
JAMA Netw Open. 2022 Sep 1;5(9):e2231196. doi: 10.1001/jamanetworkopen.2022.31196.
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.
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.
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.
Insulin sensitivity, glucose tolerance, and weight-specific quality of life (YQOL-W) at 6- and 12-month follow-up.
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).
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.
ClinicalTrials.gov Identifier: NCT02615353.
重要性：拉丁裔青少年受糖尿病前期和 2 型糖尿病（T2D）的影响不成比例。生活方式干预是预防或延缓成年人糖尿病前期发生 T2D 的首选方法。
目的：评估针对 12 至 16 岁有糖尿病前期和肥胖的拉丁裔青少年的糖尿病预防计划的疗效。
设计、地点和参与者：这项 2 组平行随机临床试验采用 2:1 随机分组，对生活方式干预与常规护理进行了比较，6 个月和 12 个月时进行随访。研究于 2016 年 5 月至 2020 年 3 月在亚利桑那州凤凰城的 YMCA 设施进行。
干预措施：参与者被随机分配到生活方式干预（INT）或常规护理对照组（UCC）。6 个月的 INT 包括每周 1 次的营养和健康教育，以及每周 3 次的体育活动。UCC 包括 2 次与儿科内分泌学家和双语、双文化注册营养师的会面，讨论糖尿病风险和健康生活方式的改变。
主要结果和措施：6 个月和 12 个月时的胰岛素敏感性、葡萄糖耐量和体重特异性生活质量（YQOL-W）。
结果：共有 117 名拉丁裔青少年（平均[标准差]年龄 14[1]岁；47[40.1%]名女孩）纳入分析。总体而言，79 名参与者被分配到 INT，38 名参与者被分配到 UCC。6 个月时，INT 显著降低了平均（SE）2 小时血糖（基线：144[3]mg/dL；6 个月：132[3]mg/dL；P=0.002）和增加了平均（SE）胰岛素敏感性（基线：1.9[0.2]；6 个月：2.6[0.3]；P=0.001）和 YQOL-W（基线：75[2]；6 个月：80[2]；P=0.006），但这些变化与 UCC 无显著差异（2 小时血糖：平均差异，-7.2mg/dL；95%CI，-19.7 至 5.3mg/dL；P 交互作用=0.26；胰岛素敏感性：平均差异，0.1；95%CI，-0.7 至 0.9；P 交互作用=0.79；YQOL-W：平均差异，6.3；95%CI，-1.1 至 13.7；P 交互作用=0.10）。INT（平均[SE]，-15mg/dL[4.9]；P=0.002）和 UCC（平均[SE]，-15mg/dL[5.4]；P=0.005）在 12 个月时均显著降低了 2 小时血糖，但彼此之间没有显著差异（平均差异，-0.3；95%CI，-14.5 至 14.1mg/dL；P 交互作用=0.97）。12 个月时，INT（基线：1.9[0.2]；12 个月：2.3[0.2]；P=0.06）和 UCC（基线：1.9[0.3]；12 个月：2.0[0.2]；P=0.70）的胰岛素敏感性变化均无显著差异（平均差异，0.3；95%CI，-0.4 至 1.0；P 交互作用=0.37）。12 个月时，INT（基线：75[2]；12 个月：82[2]；P<0.001）与 UCC（平均差异，8.5；95%CI，0.8 至 16.2；P 交互作用=0.03）相比，YQOL-W 显著增加。在成年人中有效的糖尿病预防干预措施似乎在高危青少年中也同样有效。
结论和相关性：在这项随机临床试验中，INT 和 UCC 均使糖尿病前期风险因素发生了类似的变化；然而，INT 与 UCC 相比，YQOL-W 得到了改善。在成年人中有效的糖尿病预防干预措施似乎在高危青少年中也同样有效。
试验注册：ClinicalTrials.gov 标识符：NCT02615353。
