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

University of Colorado Denver (CU Denver)

Status: Active, not recruiting

Conditions: Overweight/Obesity

Treatments: Behavioral: Active Living; Other: Health and Safety

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03573856

R01DK115434 (U.S. NIH Grant/Contract)

17-1306

Details and patient eligibility

About

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

Full 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).

Enrollment: 188 patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 2 patient groups, including a placebo group

Active Living

Active Comparator group

Description:

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

Treatment:

Behavioral: Active Living

Health and Safety

Placebo Comparator group

Description:

One component health and safety program consisting of group classes

Treatment:

Other: Health and Safety