UCSD Take Charge Study

Not Applicable

Completed

• Conditions: Overweight; Obese; Obesity; Diabetic; Type 2 Diabetes
• Interventions: Other: Higher Carbohydrate, Lower Fat Diet; Other: Lower carbohydrate, Higher fat diet; Other: Individualized Counseling

• Registration Number: NCT01345500
• Lead Sponsor: University of California, San Diego

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-05-02
• Study Start: 2012-02
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-13
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Higher Carbohydrate/Lower Fat Diet	Higher Carbohydrate, Lower Fat Diet	-
Lower Carbohydrate/Higher Fat Diet	Lower carbohydrate, Higher fat diet	-
Individualized Counseling	Individualized Counseling	-

Primary Outcome Measures

Name	Time	Method
Total weight loss	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.

Secondary Outcome Measures

Name	Time	Method
Response to macronutrient composition	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	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.

Trial Locations

Locations (2)

University of California, San Diego; 🇺🇸 La Jolla, California, United States

HealthPartners Research Foundation and University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States