Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
227 participants
INTERVENTIONAL
2012-02-29
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Higher Carbohydrate/Lower Fat Diet
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.
Lower Carbohydrate/Higher Fat Diet
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.
Individualized Counseling
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.
Interventions
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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.
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.
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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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HealthPartners Institute
OTHER
University of Minnesota
OTHER
University of California, San Diego
OTHER
Responsible Party
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Cheryl Rock
Principal Investigator
Principal Investigators
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Cheryl L Rock, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California, San Diego
La Jolla, California, United States
HealthPartners Research Foundation and University of Minnesota
Minneapolis, Minnesota, United States
Countries
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References
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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.
Other Identifiers
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110463
Identifier Type: -
Identifier Source: org_study_id