UCSD Take Charge Study

Obesity Clinical Trial

Official title:

Randomized Clinical Trial of a Weight Loss Program in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345500
• Other study ID #: 110463
• Status: Completed
• Phase: N/A
• First received: April 28, 2011
• Last updated: November 13, 2013
• Start date: February 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic
• Obese
• Obesity
• Overweight
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California
United States	HealthPartners Research Foundation and University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	HealthPartners Institute, University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	1 year	No
Secondary	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.	1 year	No