UCSD Take Charge Study
Randomized Clinical Trial of a Weight Loss Program in Type 2 Diabetes
1 other identifier
interventional
227
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2011
CompletedFirst Posted
Study publicly available on registry
May 2, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedNovember 14, 2013
November 1, 2013
1.7 years
April 28, 2011
November 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (2)
Response to macronutrient composition
1 year
Biochemical/social outcomes
1 year
Study Arms (3)
Higher Carbohydrate/Lower Fat Diet
EXPERIMENTALLower Carbohydrate/Higher Fat Diet
EXPERIMENTALIndividualized Counseling
ACTIVE COMPARATORInterventions
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.
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.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- HealthPartners Institutecollaborator
- University of Minnesotacollaborator
Study Sites (2)
University of California, San Diego
La Jolla, California, 92093-0901, United States
HealthPartners Research Foundation and University of Minnesota
Minneapolis, Minnesota, United States
Related Publications (1)
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.
PMID: 24760261DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl L Rock, PhD, RD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 28, 2011
First Posted
May 2, 2011
Study Start
February 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
November 14, 2013
Record last verified: 2013-11