NCT01345500

UCSD Take Charge Study

Randomized Clinical Trial of a Weight Loss Program in Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2011-05-02
• Last updated: 2013-11-14

Locations

2 sites across 1 country: United States