UCSD Take Charge Study
|ClinicalTrials.gov Identifier: NCT01345500|
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : November 14, 2013
|Condition or disease||Intervention/treatment|
|Overweight Obese Obesity Diabetic Type 2 Diabetes||Other: Higher Carbohydrate, Lower Fat Diet Other: Lower carbohydrate, Higher fat diet Other: Individualized Counseling|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||227 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial of a Weight Loss Program in Type 2 Diabetes|
|Study Start Date :||February 2012|
|Primary Completion Date :||October 2013|
|Study Completion Date :||October 2013|
|Experimental: Higher Carbohydrate/Lower Fat Diet||
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.
|Experimental: Lower Carbohydrate/Higher Fat Diet||
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.
|Active Comparator: Individualized Counseling||
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.
- Total weight loss [ Time Frame: 1 year ]To test, in a randomized controlled trial, whether participation in a commercial weight loss program promotes greater weight loss and weight loss maintenance at one year in overweight or obese men and women with type 2 diabetes compared to usual care conditions.
- Response to macronutrient composition [ Time Frame: 1 year ]To examine whether there is a differential weight loss response at 3, 6 and/or 12 months to different dietary macronutrient composition (higher carbohydrate and lower fat versus lower carbohydrate and higher fat) in the weight loss intervention in these overweight or obese men and women with type 2 diabetes.
- Biochemical/social outcomes [ Time Frame: 1 year ]To describe the effect of participating in the program (vs. usual care) on markers of glycemic control, cardiovascular disease risk, cardiopulmonary fitness, plasma carotenoids, quality of life, and eating attitudes and behaviors. Also to examine whether there is a differential response to different dietary macronutrient composition in the two weight loss intervention groups in selected metabolic factors, lipids and CRP at 6 and 12 months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345500
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093-0901|
|United States, Minnesota|
|HealthPartners Research Foundation and University of Minnesota|
|Minneapolis, Minnesota, United States|
|Principal Investigator:||Cheryl L Rock, PhD, RD||University of California, San Diego|