UCSD Take Charge Study
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Diego
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: August 8, 2012
Last verified: August 2012
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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.
| Estimated Enrollment: | 225 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | March 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
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
| 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: | August 8, 2012 |
| 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 Obesity Overweight Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Overnutrition Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013