Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- 2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM)
研究概览
简要总结
The purpose of this study is to determine if the Bright Bodies (BB) Healthy Lifestyle Program can help reverse early abnormalities in glucose metabolism and prevent the progression to type 2 diabetes (T2DM) in high-risk, obese youth with newly-diagnosed impaired glucose tolerance (IGT).
详细描述
Primary Aim: (1) To determine whether youth randomized to the Bright Bodies (BB) Healthy Lifestyle Program have lower 2-hr plasma glucose levels than those randomized to standard lifestyle counseling (control) after 6 months.
Secondary Aims: (2) To determine if greater conversions from IGT to normal glucose tolerance (NGT) and less development of T2DM occurs for those in the BB vs Control Group; (3)To determine if there is improvement in anthropometric/metabolic parameters in BB vs Control Group; and (4) To determine if there is an improvement in psychosocial and family dynamic outcomes of the child in BB vs Control Group.
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
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IGT (glucose 140-199 at 2 hrs during OGTT)
- •Age 11 to 16
- •An interest in being enrolled in a healthy lifestyle program
- •A parent/caregiver willing to participate with child in program
排除标准
- •Psychiatric disorder or serious medical condition that would preclude participation in program
- •Currently taking medication that potentially effects insulin sensitivity (eg Metformin) or causes weight gain (example: Risperidone) or weight loss (eg Xenical)
- •Involvement in co-existing weight management/healthy lifestyle program
- •Plans of moving out of the Greater New Haven area within six months
结局指标
主要结局
2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM)
时间窗: 6 months
次要结局
- Blood pressure (BP)(6 months)
- Lipid profile(6 months)
- Alanine aminotransferase (ALT)(6 months)
- Body mass index (BMI)(6 months)
- Homeostasis model assessment of insulin resistance (HOMA-IR)(6 months)
- Body fat mass and %(6 months)
- Child behavior checklist score(6 months)
- Piers-Harris Self-concept scale score(6 months)
- Family assessment device (FAD) score(6 months)