UCSD Take Charge Study
NCT01345500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 227
Last updated 2013-11-14
Summary
The purpose of the Take Charge Study is to determine among overweight and obese men and women with type 2 diabetes whether 1) participating in a commercial weight loss program promotes great weight loss and weight loss maintenance at one year compared to usual care conditions and 2) whether there is a differential weight loss response to different dietary macronutrient composition (lower carbohydrate/higher fat diet versus a higher carbohydrate/lower fat).
Conditions
- Overweight
- Obese
- Obesity
- Diabetic
- Type 2 Diabetes
Interventions
- OTHER
-
Higher Carbohydrate, Lower Fat Diet
Study participants will receive prepackaged prepared foods as needed to achieve a meal plan, free-of-charge for a 12-month period. The lower fat, higher carbohydrate diet provides 60% energy from carbohydrate, 20% energy from fat, and 20% energy from protein. The diet falls within the range of current dietary recommendations.
- OTHER
-
Lower carbohydrate, Higher fat diet
Study participants will receive prepackaged prepared foods as needed to achieve a meal plan, free-of-charge for a 12-month period. The lower carbohydrate, higher fat diet provides 45% energy from carbohydrate, 35% energy from fat, and 20% energy from protein. The diet falls within the range of current dietary recommendations.
- OTHER
-
Individualized Counseling
Participants assigned to the usual care group will be provided consultation with a research staff dietetics professional, who will provide publicly available print material that describes dietary and physical activity guidelines to promote weight loss and maintenance, at baseline (after randomization) and again at 6 months.
Sponsors & Collaborators
-
HealthPartners Institute
collaborator OTHER - collaborator OTHER
-
University of California, San Diego
lead OTHER
Principal Investigators
-
Cheryl L Rock, PhD, RD · University of California, San Diego
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-02-29
- Primary Completion
- 2013-10-31
- Completion
- 2013-10-31
Countries
- United States
Study Locations
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