Status:
COMPLETED
Together on Diabetes Study: Evaluation of a Pilot Diabetes Prevention and Management Program for American Indian Youth
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Conditions:
Diabetes
Eligibility:
All Genders
10-19 years
Phase:
NA
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 ai...
Detailed Description
This is a single group pre-post study designed to evaluate the feasibility and effectiveness of a pilot intervention at improving the prevention and management of type 2 diabetes among American Indian...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT01910727
Start Date
December 1 2011
End Date
July 1 2015
Last Update
March 20 2017
Active Locations (1)
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1
Johns Hopkins Center for American Indian Health
Baltimore, Maryland, United States, 21205