REACH-OUT: Chicago Children's Diabetes Prevention Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)
研究概览
简要总结
The purpose of this research study is to evaluate two nutrition and exercise programs in children ages 9-12 who are at risk for developing type 2 diabetes. This study also includes the involvement of parents or guardians who are willing to participate in these programs with the child.
详细描述
This is a prevention study that evaluates a community-based, family oriented intervention called Reach-Out. The University of Chicago will partner with community organizations including the Women, Infants and Children [WIC] Clinic at the Chicago Department of Public Health Roseland Clinic, South Side YMCA, the Chicago Park District and the Southside Faith-Based Wellness Network of churches to deliver the intervention. Families will be recruited from the high risk population of patients in the University of Chicago Diabetes database and the Chicago Childhood Diabetes Registry; and La Rabida Children's Hospital; and from the broader south side African-American community ("outreach" population). Families will be randomized to behavioral intervention (Reach-Out Program, hands on nutrition and exercise) or control group(Reach-In Program, standard of care consultation).
All who participate in this study will be seen at the University of Chicago GCRC (General Clinical Research Center). They will be asked to come in at the beginning of the study, after 14 weeks, afer 1 year and after 2 years.
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
- 9 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight (>85th percentile BMI for age and gender) African American child age 9-12 with family history of type 2 diabetes in a first or second degree relative. Parents are secondary subjects.
排除标准
- •Inability to give informed consent or unwillingness to be randomized
- •Prior diagnosis of diabetes in the child planning to participate
- •Pregnancy (women who become pregnant during the study will be omitted from the analysis. Pregnant women will not participate in the exercise sessions).
- •Uncontrolled hypertension (SBP> 160 or DBP>100) (JNC V, 1993)
- •Uncontrolled dyslipidemia by NCEP III criteria (NCEP, 2001)
- •Evidence of significant cardiovascular, pulmonary disease, or other serious illness
- •Evidence of alcohol or drug abuse (identified by self-report)
- •Musculoskeletal disease serious enough to prevent participation in exercise sessions
- •Known or suspected major psychiatric disorder
- •Inability to participate in aerobic exercise activities
- •Inability to comply with a calorie or fat restricted diet
- •Age over 65 years
结局指标
主要结局
Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)
时间窗: 14 weeks, 1 year, 2 years
Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C)
时间窗: 14 weeks, 1 year, 2 years
次要结局
- Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more)(At two weekly meetings)
- Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing)(14 weeks, 1 year, 2 years)