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临床试验/NCT03573856
NCT03573856进行中(未招募)不适用

Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

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
1
主要终点
Change from 0 to 12 months in fasting insulin

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

研究组 & 干预措施

Active Living

Active Comparator

Three component behavioral intervention consisting of group-based classes, individual motivational interviewing-based sessions, and resource toolbox

干预措施: Active Living (Behavioral)

Health and Safety

Placebo Comparator

One component health and safety program consisting of group classes

干预措施: Health and Safety (Other)

结局指标

主要结局

Change from 0 to 12 months in fasting insulin

时间窗: 12 months

Change from 0 to 12 months in Body Mass Index (BMI)

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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