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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Overweight/Obesity

Intervention / Treatment
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* Behavioral: Active Living
* Other: Health and Safety


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Living<br>Three component behavioral intervention consisting of group-based classes, individual motivational interviewing-based sessions, and resource toolbox | Behavioral: Active Living<br>* Participants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living.<br>|
| Placebo Comparator: Health and Safety<br>One component health and safety program consisting of group classes | Other: Health and Safety<br>* Participants will be provided with education related to general health and safety topics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from 0 to 12 months in BMI z-score |  | 12 months | 
| Change from 0 to 12 months in waist circumference |  | 12 months | 
| Change from 0 to 12 months in hemoglobin A1c |  | 12 months | 
| Change from 0 to 12 months in fasting glucose |  | 12 months |