Insulin Superheroes Club: Diabetes Prevention Program in Youth (12-month Supplement to the CDC DPP for Adults)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Change From Baseline Hemoglobin A1c
研究概览
简要总结
The purpose of this study is to test the effectiveness of an out-of-school diabetes prevention program for youth (ages 7-15) with a family history of pre-diabetes or type 2 diabetes.
详细描述
The Insulin Superheroes Club (ISC) is based on the Diabetes Prevention Program for adults (Knowler WC et al., 2002), which was developed by the Centers for Disease Control and Prevention (CDC). We have adapted the curriculum for youth to serve a supplement to the adult program. This program lasts 12 months, and the goals are to improve participants' health and reduce their risk of developing pre-diabetes or type 2 diabetes. The ISC program includes 16 weekly (Phase 1), 3 bi-weekly (Phase 2), and 6 monthly (Phase 3) sessions. Sessions include 60 minutes of physical fitness and 30 minutes of education. The education portion includes interactive teaching of a health-related topic (e.g., nutrition, exercise, physiology, mindfulness, and stress reduction) using a hand-on learning activity (e.g., cooking, crafts, games, and role play). All physical fitness activities incorporate moderate intensity exercises (e.g., push-ups, yoga, basketball, tag, and dance).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change From Baseline Hemoglobin A1c
时间窗: 16 weeks
次要结局
- Change From Baseline HDL Cholesterol(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Triglycerides(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Six Minute Walk Test Distance(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Non-HDL Cholesterol(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Right Handgrip Strength(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Left Handgrip Strength(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Combined Handgrip Strength(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Body Mass Index Z-score(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Waist Circumference Z-score(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Systolic Blood Pressure Z-score(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Diastolic Blood Pressure Z-score(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Sit-and-reach Lower Body Flexibility(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Percent Body Fat(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Total Cholesterol(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline LDL Cholesterol(16 weeks, 6 months, 9 months, 12 months)
- Change From Baseline Shuttle Run Speed(16 weeks, 6 months, 9 months, 12 months)