UCSD Take Charge Study

University of California, San Diego227 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

227

Conditions

Overweight Obese Obesity Diabetic Type 2 Diabetes

Interventions

Higher Carbohydrate, Lower Fat DietOTHER

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.

Lower carbohydrate, Higher fat dietOTHER

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.

Individualized CounselingOTHER

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of California, San Diego

La Jolla, California, United States

HealthPartners Research Foundation and University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 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.

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.