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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03573856
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : January 4, 2019
Sponsor:
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

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).

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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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : August 2022

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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573856


Contacts
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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
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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
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Principal Investigator: Katherine Sauder, PhD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03573856     History of Changes
Other Study ID Numbers: 17-1306
R01DK115434 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms