Taking Action Together: Development, Implementation and Evaluation of Community-Based Programs That Aims to Reduce Risk of Type 2 Diabetes in High BMI African American Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- 1 Year change in insulin resistance via HOMA-IR
研究概览
简要总结
The purpose of this study was to determine whether once-weekly exposure to a program that fostered self-esteem building, and improvements in nutrition and physical activity behaviors would reduce risk of type 2 diabetes in overweight, inner-city, African American children when compared to a control group.
详细描述
In the United States and, indeed, worldwide the prevalence of overweight and obesity has increased at an unprecedented rate. Concomitant with this demographic change are increases in diseases including type 2 diabetes, cardiovascular disease and some cancers that are associated with body fatness. Strategies to reduce body weight have been largely unsuccessful, making it unlikely that our population will be made healthy simply by recommending that overweight people reduce their body fatness. There is evidence, however, that the impact of body fat on human health can be significantly attenuated by potentially achievable strategies. Such strategies require adequate intakes of essential nutrients, regular physical activity and strong self-esteem. The goal of the project is to reduce the risk of type 2 diabetes mellitus (T2DM) in overweight 9- to 10-year-old African American children through a multi-component community-based program. The specific objectives are to (1).Implement a randomly controlled 2-phase intervention involving a 2-week summer camp, and weekly & monthly reinforcement sessions over 2 years, that include nutrition education, physical activity promotion, and self-esteem and self-efficacy building and (2) Test effectiveness of the program after 1 and 2 years of intervention on insulin sensitivity, the primary outcome, and on secondary outcomes including body fatness, dietary intakes, physical activity, and self-esteem. Identifying an effective, community-based program that could reduce risk of type 2 diabetes in high-risk children would promote health, reduce disease and reduce health-care costs in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 9 Years 至 11 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child age of 9-10 yr old at baseline
- •Child BMI at least 85th percentile when matched for age and gender
- •Able and willing to participate in normal daily activities
- •Living in inner-city regions of Oakland CA
排除标准
- •Fasting blood glucose of 120 mg/dl or higher
- •Diagnosis of diabetes or other central metabolic disease
- •Taking medications that interfere with or treat main study outcomes
结局指标
主要结局
1 Year change in insulin resistance via HOMA-IR
时间窗: Change during first year
Baseline HOMA-IR minus Year 1 HOMA-IR
2 year change in insulin resistance via HOMA-IR
时间窗: Change during 2 years
Baseline HOMA-IR minus Year 2 HOMA-IR
次要结局
- Change in dietary intakes of energy, fat, carbohydrate and selected essential nutrients. Change in minutes/day spend in moderate- and high-intensity physical activity. Improvement or stabilization of self-esteem.(3years)
