Type 2 Diabetes and Obesity Pediatric Prevention Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in BMI (Body Mass Index)
研究概览
简要总结
This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. The behavioral intervention is conducted during a four hour monthly session. The behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.
详细描述
This is a long term randomized controlled trial, looking at the impact of a behavioral intervention on BMI,in participants ages 10-20 with a BMI > 85%.
The intervention group will:
- have baseline and follow up blood work (fasting insulin, glucose, lipid panel)
- have baseline and follow up BMI, blood pressure measurements
- see a dietician-minimum of three visits during study
- attend monthly, four hour sessions. These sessions include:
- registration-monitoring of choices of liquid intake using standardized models, monitoring of sedentary behaviors-hours watching television, computer, video games, monitoring of heart rate at baseline and after exercise, monitoring of METs (metabolic equivalents), motivational interviewing, monitoring of exercise abilities (endurance, agility, curl ups, balance, power)
- one hour of exercise (including strength training)
- educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic
- projects/games
- empowerment tools such as leading exercises and presenting food labels for discussion
The control group will have:
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
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 10-20 years
排除标准
- •Endocrine disorder
- •On psychotropic medications
研究组 & 干预措施
Intervention
This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention is a Behavioral education program which meets monthly for 4 hour session and includes exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
干预措施: Behavioral education program (Behavioral)
Standard of Care/Control
Education on physical activity and nutrition in a primary care office setting
结局指标
主要结局
Change in BMI (Body Mass Index)
时间窗: Baseline, 12-15 months
Percentage of Participants With BMI Reduction
时间窗: Baseline, 12-15 months
次要结局
未报告次要终点