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UCSD Take Charge Study

This study has been completed.
Sponsor:
Collaborators:
HealthPartners Institute for Education and Research
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Cheryl Rock, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01345500
First received: April 28, 2011
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention
Overweight
Obese
Obesity
Diabetic
Type 2 Diabetes
Other: Higher Carbohydrate, Lower Fat Diet
Other: Lower carbohydrate, Higher fat diet
Other: Individualized Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of a Weight Loss Program in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Total weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Response to macronutrient composition [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 227
Study Start Date: February 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345500

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093-0901
United States, Minnesota
HealthPartners Research Foundation and University of Minnesota
Minneapolis, Minnesota, United States
Sponsors and Collaborators
University of California, San Diego
HealthPartners Institute for Education and Research
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Cheryl L Rock, PhD, RD University of California, San Diego
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheryl Rock, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01345500     History of Changes
Other Study ID Numbers: 110463
Study First Received: April 28, 2011
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Overweight
Obese
Type 2 Diabetic
Diabetes
Weight loss
Physical activity
Diet
Prepackaged meals

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014