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临床试验/NCT02458131
NCT02458131已完成不适用

TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Change in body mass index (BMI)

研究概览

简要总结

The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a disproportionate increase among minority youth. The research proposed in this Career Development Award will use community-based participatory research methodology as well as novel strategies (peer education and mobile health technologies) to design, implement and evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban community with high disease burden.

详细描述

Approach: The proposed research addresses diabetes risk and prevention among racial/ethnic minority adolescents in East Harlem (EH), NY. Aim 1 will use qualitative methods to explore the best strategies for using peer education for diabetes risk reduction in youth and the potential role of mobile health technologies in improving adherence to behavioral modification plans. Aim 2 will utilize findings from preliminary studies and Aim 1 to design and evaluate a pilot community-based intervention to 1) maintain/reduce BMI (primary outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and 3) improve other measures of diabetes risk. Data will be collected at baseline, immediately after the intervention (3 months) and at one year in the intervention and wait list control groups. Aim 3 involves refining the pilot intervention based on an examination of intervention feasibility, acceptability, and sustainability and planning for a future R01.

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
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in body mass index (BMI)

时间窗: Baseline and 3 months

Change in BMI at post-intervention (approximately 3 months) as compared to baseline

Change in BMI

时间窗: Baseline and 1 year

Change in BMI at 1 year as compared to baseline

次要结局

  • Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss(Baseline and 1 year)
  • Change in fasting blood glucose levels(Baseline and 1 year)
  • Change in post prandial blood glucose level(Baseline and 1 year)
  • Change in blood pressure(Baseline and 1 year)
  • Change in percent body fat(Baseline and 1 year)
  • Change in waist circumference(Baseline and 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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