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