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Completed

NCT Number: NCT01345500

UCSD Take Charge Study

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).

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Key information

Conditions

Overweight Behavior Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Higher Carbohydrate, Lower Fat Diet

Other

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 diet

Other

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 Counseling

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • HealthPartners Institute
  • University of Minnesota

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 2, 2011
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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