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

Overweight/Obesity Clinical Trial

— TTP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03573856
• Other study ID #: 17-1306
• Secondary ID: R01DK115434
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: September 2023

Study information

• Verified date: November 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight/Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Childrens Hospital Colorado	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from 0 to 12 months in fruit/vegetable intake	Proportion consuming 5+ servings of fruits/vegetables daily	12 months
Other	Change from 0 to 12 months in physical activity	Proportion engaging in 1+ hour of moderate-vigorous physical activity daily	12 months
Other	Change from 0 to 12 months in screen time	Proportion watching 2 hours or less of screen time daily	12 months
Other	Change from 0 to 12 months in sugary beverage intake	Proportion consuming 0 servings of sugary beverages daily	12 months
Other	Participant engagement	Qualitative factors related to participant engagement	12 months
Other	Program implementation	Qualitative factors related to program implementation	12 months
Other	Potential for sustained delivery	Qualitative factors related to potential for sustained delivery	12 months
Primary	Change from 0 to 12 months in Body Mass Index (BMI)		12 months
Primary	Change from 0 to 12 months in fasting insulin		12 months
Secondary	Change from 0 to 12 months in BMI z-score		12 months
Secondary	Change from 0 to 12 months in waist circumference		12 months
Secondary	Change from 0 to 12 months in hemoglobin A1c		12 months
Secondary	Change from 0 to 12 months in fasting glucose		12 months