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

NCT ID: NCT03573856

Last Updated: 2022-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2023-09-30

Brief Summary

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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

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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).

Conditions

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Overweight/Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Active Living

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

Group Type ACTIVE_COMPARATOR

Active Living

Intervention Type BEHAVIORAL

Participants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living.

Health and Safety

One component health and safety program consisting of group classes

Group Type PLACEBO_COMPARATOR

Health and Safety

Intervention Type OTHER

Participants will be provided with education related to general health and safety topics.

Interventions

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Active Living

Participants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living.

Intervention Type BEHAVIORAL

Health and Safety

Participants will be provided with education related to general health and safety topics.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine Sauder, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Childrens Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK115434

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-1306

Identifier Type: -

Identifier Source: org_study_id

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