Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Change from 0 to 12 months in Body Mass Index (BMI)
研究概览
简要总结
This study will evaluate a behavioral intervention designed to reduce risk factors for type 2 diabetes in American Indian youth aged 7-10 years.
详细描述
The objectives of tis study are to rigorously evaluate the effect of Tribal Turning Point (TTP) on diabetes risk factors in Native youth. The investigators will enroll up to 360 youth who are aged 7-10 years, overweight/obese (BMI >85th percentile), self-identify as American Indian, and have >1 parent/primary caregiver willing to actively participate in the program. Within each community, youth will be randomized to the TTP program or a general health and safety control program. The multi-component TTP intervention is a youth-centered adaptation of the Diabetes Prevention Program designed to reduce diabetes risk factors by improving activity and dietary behaviors. Informed by the pediatric weight management literature, the 12-month intervention includes 12 active learning group classes, 7 individual youth/parent motivational interviewing counseling sessions, and community-specific resource toolboxes. In this trial, the investigators will assess the effect of TTP on anthropometric, metabolic, and behavioral risk factors for type 2 diabetes at the end of the intervention (12mo) and after 1 year of follow-up (24mo).
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
- Single (Investigator)
入排标准
- 年龄范围
- 7 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-identify as American Indian
- •BMI >=85th percentile for age and sex
- •have at least one parent/primary caregiver (parent) willing to actively participate
排除标准
- •any serious youth/parent health concerns that would interfere with participation
- •plans to move out of the area during the study period
结局指标
主要结局
Change from 0 to 12 months in Body Mass Index (BMI)
时间窗: 12 months
Change from 0 to 12 months in fasting insulin
时间窗: 12 months
次要结局
- Change from 0 to 12 months in waist circumference(12 months)
- Change from 0 to 12 months in fasting glucose(12 months)
- Change from 0 to 12 months in hemoglobin A1c(12 months)
- Change from 0 to 12 months in BMI z-score(12 months)
