Aurora, Colorado 80045

  • Overweight/Obesity

Purpose:

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 summary:

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).


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: - diabetes - any serious youth/parent health concerns that would interfere with participation - plans to move out of the area during the study period


NCT ID:

NCT03573856


Primary Contact:

Principal Investigator
Katherine Sauder, PhD
University of Colorado, Denver

Katherine Sauder, PhD
Phone: 720-717-1216
Email: katherine.sauder@ucdenver.edu


Backup Contact:

Email: dana.dabelea@ucdenver.edu
Dana M Dabelea, MD; PhD
Phone: 303-724-4414


Location Contact:

Aurora, Colorado 80045
United States

Katherine A Sauder, PhD

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 12, 2021

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