- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01910727
Together on Diabetes Study: Evaluation of a Pilot Diabetes Prevention and Management Program for American Indian Youth
The objective of the Together on Diabetes study is to test the efficacy of a pilot intervention to improve the prevention and management of type 2 diabetes among American Indian youth.
The primary aim of this study is to determine the impact of the Together on Diabetes pilot intervention on youth diabetes risk behaviors, including:
- Improvement in youth dietary intake, with a specific focus on reducing the percent of total calories from fat.
- Improvement in youth physical activity, with a specific focus on increasing the number of minutes of physical activity each week.
An additional primary aim of the study is to determine the feasibility and acceptability of the pilot intervention and evaluation, including program adherence and program satisfaction.
The secondary aim of this study is to determine the feasibility of collecting data to determine program impact on a number of physiological measures.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Center for American Indian Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
(YOUTH PARTICIPANT) --
- American Indian youth aged 10-19 years old at enrollment
- Resides within 1-hour transportation range (~ 50 miles) of the participating Indian Health Service (IHS) medical facilities (Tuba City, Arizona; Chinle, Arizona; Shiprock, New Mexico; Whiteriver, Arizona).
- Parent/guardian consent for youth under 18 years old.
- Referral from an Indian Health Services provider indicating a diagnosis by laboratory test of type 2 diabetes or pre-diabetes OR considered at-risk for type 2 diabetes based on BMI ≥ 85th percentile and qualifying lab test
(SUPPORT PERSON) --
- Adults 18 years of age or older
- Identified on the Youth Participant consent form as the preferred Support Person to be enrolled in the program
- Living with the enrolled Youth Participant or within 15 miles of the youth
Exclusion Criteria:
(YOUTH PARTICIPANT)
- Females who are pregnant or nursing or are planning to become pregnant within one year of enrollment
- Diabetes due to secondary causes, such as exogenous steroids, Cushing's, or Cystic Fibrosis
- Youth with type 1 diabetes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Together on Diabetes-Hopkins
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The Johns Hopkins Center for American Indian Health, with support from Bristol-Myers Squibb Foundation, Inc. is adapting a Family Health Coach model for diabetes prevention with four southwestern tribal communities.
Specifically, Johns Hopkins Center for American Indian Health has designed a paraprofessional delivered pilot intervention aimed at improving the prevention and management of type 2 diabetes among American Indian youth.
For Youth Participants, the pilot intervention consists of 12 sessions delivered during a 6-month intervention phase, plus 6 check-ins delivered during a 6-month follow-up phase.
For Support Persons, the pilot intervention consists of 4 family skill building sessions delivered during the first 4 months of the Youth Participant's intervention phase.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in percent of total calories from fat from baseline through 12 months follow-up
Time Frame: 12 months follow-up
|
12 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increased physical activity levels between baseline and 12 months follow-up
Time Frame: 12 months follow-up
|
12 months follow-up
|
Decreased body mass index between baseline and 12 months follow-up
Time Frame: 12 months follow-up
|
12 months follow-up
|
Improvement in point of care Hemoglobin A1C level between baseline and 12 month follow-up
Time Frame: 12 months follow-up
|
12 months follow-up
|
Decrease in waist circumference between baseline and 12 months follow-up
Time Frame: 12 months follow-up
|
12 months follow-up
|
Decreased blood pressure between baseline and 12 months follow-up
Time Frame: 12 months follow-up
|
12 months follow-up
|
Improvements in youth diabetes knowledge test score between baseline and 12 months follow-up
Time Frame: 12 months follow-up
|
12 months follow-up
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Improved score on Pediatric quality of life assessment (Ped-QL) between baseline and 12 months follow-up
Time Frame: 12 months follow-up
|
12 months follow-up
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Increased numbers of family members involved in diabetes support care between baseline and 12 months follow-up
Time Frame: 12 months follow-up
|
12 months follow-up
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Increased numbers of individuals having been screen for diabetes between baseline and 12 months follow-up
Time Frame: 12 months follow-up
|
12 months follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Allison Barlow, MPH, MA, Johns Hopkins Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Together on Diabetes - JHSPH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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