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

Not Applicable

Active, not recruiting

• Conditions: Overweight/Obesity

• Registration Number: NCT03573856
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This study will evaluate a behavioral intervention designed to reduce risk factors for type 2 diabetes in American Indian youth aged 7-10 years.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2018-05-21
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-29
• Study Start: 2018-07-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-21
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• self-identify as American Indian
• BMI >=85th percentile for age and sex
• have at least one parent/primary caregiver (parent) willing to actively participate

Exclusion Criteria

• diabetes
• any serious youth/parent health concerns that would interfere with participation
• plans to move out of the area during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from 0 to 12 months in Body Mass Index (BMI)	12 months
Change from 0 to 12 months in fasting insulin	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Childrens Hospital Colorado; 🇺🇸 Aurora, Colorado, United States