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

• ClinicalTrials.gov Identifier: NCT03573856
• Recruitment Status: Recruiting
• First Posted: June 29, 2018
• Last Update Posted: October 27, 2021
• Sponsor: University of Colorado, Denver
• Collaborators: National Institutes of Health (NIH); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Overweight/Obesity	Behavioral: Active Living; Other: Health and Safety	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point
• Actual Study Start Date: July 1, 2018
• Estimated Primary Completion Date: September 2023
• Estimated Study Completion Date: September 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change from 0 to 12 months in Body Mass Index (BMI) [ Time Frame: 12 months ]
2. Change from 0 to 12 months in fasting insulin [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Change from 0 to 12 months in BMI z-score [ Time Frame: 12 months ]
2. Change from 0 to 12 months in waist circumference [ Time Frame: 12 months ]
3. Change from 0 to 12 months in hemoglobin A1c [ Time Frame: 12 months ]
4. Change from 0 to 12 months in fasting glucose [ Time Frame: 12 months ]

Other Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Katherine Sauder, PhD; 720-717-1216; katherine.sauder@ucdenver.edu

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

Locations

United States, Colorado

Childrens Hospital Colorado; Recruiting

Aurora, Colorado, United States, 80045

Contact: Katherine A Sauder, PhD

Sponsors and Collaborators

University of Colorado, Denver

National Institutes of Health (NIH)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Katherine Sauder, PhD; University of Colorado, Denver

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03573856
• Other Study ID Numbers: 17-1306; R01DK115434 ( U.S. NIH Grant/Contract )
• First Posted: June 29, 2018
• Last Update Posted: October 27, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Overweight; Body Weight