Together on Diabetes Study: Evaluation of a Pilot Diabetes Prevention and Management Program for American Indian Youth
1 other identifier
interventional
506
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Dec 2011
Longer than P75 for not_applicable diabetes
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
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 17, 2013
CompletedFirst Posted
Study publicly available on registry
July 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMarch 20, 2017
March 1, 2017
3.6 years
July 17, 2013
March 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in percent of total calories from fat from baseline through 12 months follow-up
12 months follow-up
Secondary Outcomes (9)
Increased physical activity levels between baseline and 12 months follow-up
12 months follow-up
Decreased body mass index between baseline and 12 months follow-up
12 months follow-up
Improvement in point of care Hemoglobin A1C level between baseline and 12 month follow-up
12 months follow-up
Decrease in waist circumference between baseline and 12 months follow-up
12 months follow-up
Decreased blood pressure between baseline and 12 months follow-up
12 months follow-up
- +4 more secondary outcomes
Study Arms (1)
Together on Diabetes-Hopkins
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Center for American Indian Health
Baltimore, Maryland, 21205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allison Barlow, MPH, MA
Johns Hopkins Bloomberg School of Public Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2013
First Posted
July 30, 2013
Study Start
December 1, 2011
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
March 20, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share