PrimaryCare: Weight Loss Maintenance in Primary Care

Sponsor

Drexel University (Other)

Overall Status

Completed

CT.gov ID

NCT00455780

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

238

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

After a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. Aim 1: To test the hypothesis that the meal replacement (MR) and reduced energy density eating (REDE) interventions, when added separately to the LEARN program, will produce superior weight loss maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the weight loss maintenance condition that combines MRs and REDE will produce better maintenance of weight losses than either individual component and than the LEARN-only condition. Aim 3: To test the hypothesis that the two conditions receiving the REDE intervention will experience longer-lasting improvements in the energy density and nutritional composition of the diet compared to the two non-REDE conditions.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight	Behavioral: Weight Loss Phase Behavioral: Continued CBT Behavioral: reduced energy density education Behavioral: continued use of meal replacements	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

238 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Weight Loss Maintenance in Primary Care

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MR-/REDE- Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance.	Behavioral: Weight Loss Phase Weight loss using CBT and meal replacements Behavioral: Continued CBT Using CBT during weight loss maintenance
Experimental: MR+/REDE- Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance.	Behavioral: Weight Loss Phase Weight loss using CBT and meal replacements Behavioral: Continued CBT Using CBT during weight loss maintenance Behavioral: continued use of meal replacements continued use of meal replacements during weight loss maintenance
Experimental: MR-/REDE+ Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance.	Behavioral: Weight Loss Phase Weight loss using CBT and meal replacements Behavioral: Continued CBT Using CBT during weight loss maintenance Behavioral: reduced energy density education Additional nutritional learning
Experimental: MR+/REDE+ Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy, as well as Reduced Energy Density Education and continued meal replacement use, for weight loss maintenance.	Behavioral: Weight Loss Phase Weight loss using CBT and meal replacements Behavioral: Continued CBT Using CBT during weight loss maintenance Behavioral: reduced energy density education Additional nutritional learning Behavioral: continued use of meal replacements continued use of meal replacements during weight loss maintenance

Outcome Measures

Primary Outcome Measures

Weight [baseline, 3 months, 12 months, 24 months, 36 months]

Secondary Outcome Measures

Body composition [baseline, 3 months, 12 months, 24 months, 36 months]
Blood work results [baseline, 3 months, 12 months, 24 months]
Scores on questionnaire-based measures [baseline, 3 months, 12 months, 24 months, 36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

BMI of 30, or BMI of 27 with weight-related comorbidities
Access to a telephone and voice mail/answering machine
MUST be seeing a primary care physician working with us on this study (in the greater Philadelphia area)

Exclusion Criteria:

Previously/currently diagnosed with an eating disorder
Current bi-polar, depression, substance abuse, or dependence disorder
Living with someone already enrolled
Enrolled in another weight loss program
Current disorder/medications affecting body weight or energy expenditure (e.g. thyroid disease)
Myocardial infraction within the past three months
Unstable angina
Nephrotic syndrome/malabsorptive disease
Gout attack within the past year
Lactating/pregnant (or planning within next two years)
Current/recent history of cancer, neurological disease, high creatinine levels, active hepatic disease