Back to resultsUCSD Take Charge Study
Primary Purpose
Overweight, Obese, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Higher Carbohydrate, Lower Fat Diet
Lower carbohydrate, Higher fat diet
Individualized Counseling
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Overweight, Obese, Type 2 Diabetic, Diabetes, Weight loss, Physical activity, Diet, Prepackaged meals
Eligibility 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
Sites / Locations
- University of California, San Diego
- HealthPartners Research Foundation and University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Higher Carbohydrate/Lower Fat Diet
Lower Carbohydrate/Higher Fat Diet
Individualized Counseling
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01345500
First Posted
April 28, 2011
Last Updated
November 13, 2013
Sponsor
University of California, San Diego
Collaborators
HealthPartners Institute, University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01345500
Brief Title
UCSD Take Charge Study
Official Title
Randomized Clinical Trial of a Weight Loss Program in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
HealthPartners Institute, University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese, Obesity, Diabetic, Type 2 Diabetes
Keywords
Overweight, Obese, Type 2 Diabetic, Diabetes, Weight loss, Physical activity, Diet, Prepackaged meals
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
227 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Higher Carbohydrate/Lower Fat Diet
Arm Type
Experimental
Arm Title
Lower Carbohydrate/Higher Fat Diet
Arm Type
Experimental
Arm Title
Individualized Counseling
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Higher Carbohydrate, Lower Fat Diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Lower carbohydrate, Higher fat diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Individualized Counseling
Intervention Description
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 Outcome Measure Information:
Title
Total weight loss
Description
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 Outcome Measure Information:
Title
Response to macronutrient composition
Description
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
Title
Biochemical/social outcomes
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl L Rock, PhD, RD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0901
Country
United States
Facility Name
HealthPartners Research Foundation and University of Minnesota
City
Minneapolis
State/Province
Minnesota
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24760261
Citation
Rock CL, Flatt SW, Pakiz B, Taylor KS, Leone AF, Brelje K, Heath DD, Quintana EL, Sherwood NE. Weight loss, glycemic control, and cardiovascular disease risk factors in response to differential diet composition in a weight loss program in type 2 diabetes: a randomized controlled trial. Diabetes Care. 2014 Jun;37(6):1573-80. doi: 10.2337/dc13-2900. Epub 2014 Apr 23.
Results Reference
derived
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