Preventing Diabetes in Latino Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Glucose Tolerance
研究概览
简要总结
Obesity and type 2 diabetes are critical public health issues in youth. This study will test the effects and estimate the cost-effectiveness of a culturally-grounded community-based lifestyle intervention on type 2 diabetes risk among obese Latino adolescents with prediabetes.
详细描述
Obesity and related health disparities represent some of the most significant public health challenges facing society. In particular, 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. The Diabetes Prevention Program established that lifestyle intervention can prevent or delay type 2 diabetes in adults with prediabetes. To date, no diabetes prevention studies have been conducted in obese Latino youth with prediabetes, a highly vulnerable and underserved group. Therefore, investigators 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. Investigators will further test intervention effects on changes in quality of life, explore the potential mediating effects of changes in 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. The overall approach is framed within a multilevel Ecodevelopmental model that leverages community, family, peer, and individual factors during the critical transition period of adolescence when changes in health behaviors and health outcomes are linked to future health trajectories. The intervention is 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. The proposal 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Latino: self-report
- •Age: 12-16
- •Obese: BMI percentile ≥95th percentile for age and gender or BMI ≥30 kg/m22
- •Prediabetic: fasting glucose ≥100, or 2-hour post-OGTT glucose ≥120 mg/dl, or HbA1c ≥5.7
排除标准
- •Taking medication(s) or diagnosed with a condition that influences carbohydrate metabolism, PA, and/or cognition
- •Type 2 diabetes: Fasting glucose ≥126 mg/dl or 2-hour glucose ≥200 mg/dl, or HbA1c ≥6.5
- •Recent Hospitalization (previous 2 months)
- •Currently enrolled in (or within previous 6 months) a formal weight loss program.
- •Diagnosed depression or other condition that may impact QoL
结局指标
主要结局
Glucose Tolerance
时间窗: 6-months, 12-months
Change in 2 hour glucose concentration following a 75 gram Oral Glucose Tolerance Test
Insulin Sensitivity
时间窗: 6-months, 12-months
Change in Insulin Sensitivity following a 75 gram Oral Glucose Tolerance Test. Insulin sensitivity will be estimated by the Whole-body insulin sensitivity index (Matsuda Index).
次要结局
- Youth Quality of Life(6-months, 12-months)
- Body Composition(6-months, 12-months)