UCSD Take Charge Study

Study Overview
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Brief Summary
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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).

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

Conditions
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Obese, Overweight, Obesity, Diabetic, Type 2 Diabetes

Intervention / Treatment
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* Other: Higher Carbohydrate, Lower Fat Diet
* Other: Lower carbohydrate, Higher fat diet
* Other: Individualized Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older Type 2 diabetes BMI 25-45 kg/m2 Willing to participate in any of the study diet arms (higher or lower carbohydrate diet or usual care) over a one-year period Able to comply with all required study procedures and schedule Must live within the San Diego or Minneapolis area Exclusion Criteria: Pregnant, breastfeeding or planning to become pregnant in the next year Serious medical condition or psychiatric illness History of having an eating disorder, food allergy or food intolerance Have food restrictions or requires a special diet Objects to frozen, processed or prepackaged foods Inability to be moderately physically active Currently enrolled in a weight loss program or another diet intervention Current use of weight loss medication or supplements Planned surgical procedure that can impact the conduct of the study Previous surgical procedures for weight reduction Does not have own transportation Have plans to relocate from area within 1 year HbA1C >11%, fasting triglycerides >600 mg/dL, serum creatinine >1.4 mg/dL (women) or 1.5 mg/dL (men) -- to be screened at baseline visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Higher Carbohydrate/Lower Fat Diet<br> | Other: Higher Carbohydrate, Lower Fat Diet<br>* 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.<br>|
| Experimental: Lower Carbohydrate/Higher Fat Diet<br> | Other: Lower carbohydrate, Higher fat diet<br>* 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.<br>|
| Active Comparator: Individualized Counseling<br> | Other: Individualized Counseling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total weight loss | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to macronutrient composition | 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. | 1 year | 
| Biochemical/social outcomes | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obese, Type 2 Diabetic, Diabetes, Weight loss, Physical activity, Diet, Prepackaged meals