Together on Diabetes Study: Evaluation of a Pilot Diabetes Prevention and Management Program for American Indian Youth
Completed · Not applicable
Conditions studied: Diabetes
In brief
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.
Key facts
- Study ID
- NCT01910727
- Run by
- Johns Hopkins Bloomberg School of Public Health
- People needed
- 506
- Starts
- 2011-12-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2017-03-20
Who can join
Age: 10 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Johns Hopkins Center for American Indian Health — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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