UCSD Take Charge Study

November 13, 2013 updated by: Cheryl Rock, University of California, San Diego

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0901
        • University of California, San Diego
    • Minnesota
      • Minneapolis, Minnesota, United States
        • HealthPartners Research Foundation and University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

University of Minnesota
HealthPartners Institute

Investigators

  • Principal Investigator: Cheryl L Rock, PhD, RD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

April 28, 2011

First Posted (Estimate)

May 2, 2011

Study Record Updates

Last Update Posted (Estimate)

November 14, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110463

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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