NCT00438126CompletedNot Applicable
Family-Centered Diabetes Project - Sharing Wisdom
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)2 sites in 1 country200 target enrollmentStarted: January 2002Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- increased self-reported leisure physical activity
Study Overview
Brief Summary
This is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women
Detailed Description
Two hundred American Indian women aged 18 to 40 years were recruited from a large Southwest city to participate in a type 2 diabetes prevention intervention. Half of the women were randomized to participated in the educational intervention and half were assigned to a delayed intervention. Measures were obtained at baseline, 6-months,12-months and 18-months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •American Indian women
- •Aged 18-40 years
- •Living in Albuquerque area
- •Not having diabetes
Exclusion Criteria
- •Pregnancy
- •Planning to become pregnant within 2 years
- •Diagnosed with diabetes fasting blood glucose > 126 planning to move out of town in next 2 years
Outcomes
Primary Outcomes
increased self-reported leisure physical activity
decreased dietary fat intake
increased vegetable consumption
Secondary Outcomes
- serum free insulin
- Body Mass Index
- waist circumference
- decreased dietary intake of total sugar
- decreased time watching television
- resting blood pressure
- HOMA
- fasting glucose
Investigators
Study Sites (2)
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