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Clinical Trials/NCT03573856
NCT03573856
Active, not recruiting
Not Applicable

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

University of Colorado, Denver1 site in 1 country188 target enrollmentJuly 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight/Obesity
Sponsor
University of Colorado, Denver
Enrollment
188
Locations
1
Primary Endpoint
Change from 0 to 12 months in Body Mass Index (BMI)
Status
Active, not recruiting
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
September 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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

Time Frame: 12 months

Change from 0 to 12 months in fasting insulin

Time Frame: 12 months

Secondary Outcomes

  • 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)

Study Sites (1)

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