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

Primary Purpose

Overweight/Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Living
Health and Safety
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight/Obesity

Eligibility Criteria

7 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Childrens Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Living

Health and Safety

Arm Description

Three component behavioral intervention consisting of group-based classes, individual motivational interviewing-based sessions, and resource toolbox

One component health and safety program consisting of group classes

Outcomes

Primary Outcome Measures

Change from 0 to 12 months in Body Mass Index (BMI)
Change from 0 to 12 months in fasting insulin

Secondary Outcome Measures

Change from 0 to 12 months in BMI z-score
Change from 0 to 12 months in waist circumference
Change from 0 to 12 months in hemoglobin A1c
Change from 0 to 12 months in fasting glucose

Full Information

First Posted
May 21, 2018
Last Updated
November 17, 2022
Sponsor
University of Colorado, Denver
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03573856
Brief Title
Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point
Acronym
TTP
Official Title
Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight/Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Living
Arm Type
Active Comparator
Arm Description
Three component behavioral intervention consisting of group-based classes, individual motivational interviewing-based sessions, and resource toolbox
Arm Title
Health and Safety
Arm Type
Placebo Comparator
Arm Description
One component health and safety program consisting of group classes
Intervention Type
Behavioral
Intervention Name(s)
Active Living
Intervention Description
Participants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living.
Intervention Type
Other
Intervention Name(s)
Health and Safety
Intervention Description
Participants will be provided with education related to general health and safety topics.
Primary Outcome Measure Information:
Title
Change from 0 to 12 months in Body Mass Index (BMI)
Time Frame
12 months
Title
Change from 0 to 12 months in fasting insulin
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from 0 to 12 months in BMI z-score
Time Frame
12 months
Title
Change from 0 to 12 months in waist circumference
Time Frame
12 months
Title
Change from 0 to 12 months in hemoglobin A1c
Time Frame
12 months
Title
Change from 0 to 12 months in fasting glucose
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Change from 0 to 12 months in fruit/vegetable intake
Description
Proportion consuming 5+ servings of fruits/vegetables daily
Time Frame
12 months
Title
Change from 0 to 12 months in physical activity
Description
Proportion engaging in 1+ hour of moderate-vigorous physical activity daily
Time Frame
12 months
Title
Change from 0 to 12 months in screen time
Description
Proportion watching 2 hours or less of screen time daily
Time Frame
12 months
Title
Change from 0 to 12 months in sugary beverage intake
Description
Proportion consuming 0 servings of sugary beverages daily
Time Frame
12 months
Title
Participant engagement
Description
Qualitative factors related to participant engagement
Time Frame
12 months
Title
Program implementation
Description
Qualitative factors related to program implementation
Time Frame
12 months
Title
Potential for sustained delivery
Description
Qualitative factors related to potential for sustained delivery
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Sauder, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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

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