Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point
TTP
2 other identifiers
interventional
188
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2018
CompletedFirst Posted
Study publicly available on registry
June 29, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedNovember 21, 2022
November 1, 2022
5.2 years
May 21, 2018
November 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Change from 0 to 12 months in Body Mass Index (BMI)
12 months
Change from 0 to 12 months in fasting insulin
12 months
Secondary Outcomes (4)
Change from 0 to 12 months in BMI z-score
12 months
Change from 0 to 12 months in waist circumference
12 months
Change from 0 to 12 months in hemoglobin A1c
12 months
Change from 0 to 12 months in fasting glucose
12 months
Other Outcomes (7)
Change from 0 to 12 months in fruit/vegetable intake
12 months
Change from 0 to 12 months in physical activity
12 months
Change from 0 to 12 months in screen time
12 months
- +4 more other outcomes
Study Arms (2)
Active Living
ACTIVE COMPARATORThree component behavioral intervention consisting of group-based classes, individual motivational interviewing-based sessions, and resource toolbox
Health and Safety
PLACEBO COMPARATOROne component health and safety program consisting of group classes
Interventions
Participants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living.
Participants will be provided with education related to general health and safety topics.
Eligibility Criteria
You may qualify if:
- self-identify as American Indian
- BMI \>=85th percentile for age and sex
- have at least one parent/primary caregiver (parent) willing to actively participate
You may not qualify if:
- diabetes
- any serious youth/parent health concerns that would interfere with participation
- plans to move out of the area during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Childrens Hospital Colorado
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Sauder, PhD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2018
First Posted
June 29, 2018
Study Start
July 1, 2018
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
November 21, 2022
Record last verified: 2022-11