NCT03573856

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 7 Years – 10 Years
• Healthy volunteers: Accepted

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).

Conditions

• Overweight/Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Active Living	Participants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living.
OTHER	Health and Safety	Participants will be provided with education related to general health and safety topics.

Timeline

• Start date: 2018-07-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2018-06-29
• Last updated: 2022-11-21

Locations

1 site across 1 country: United States