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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight/Obesity
• Intervention / Treatment: Behavioral: Active Living; Other: Health and Safety

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).

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Childrens Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from 0 to 12 months in fruit/vegetable intake	Proportion consuming 5+ servings of fruits/vegetables daily	12 months
Change from 0 to 12 months in physical activity	Proportion engaging in 1+ hour of moderate-vigorous physical activity daily	12 months
Change from 0 to 12 months in screen time	Proportion watching 2 hours or less of screen time daily	12 months
Change from 0 to 12 months in sugary beverage intake	Proportion consuming 0 servings of sugary beverages daily	12 months
Participant engagement	Qualitative factors related to participant engagement	12 months
Program implementation	Qualitative factors related to program implementation	12 months
Potential for sustained delivery	Qualitative factors related to potential for sustained delivery	12 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2018
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (ACTUAL): June 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 17-1306; R01DK115434 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No