Weight Loss Maintenance in Primary Care

Not Applicable

Completed

• Conditions: Obesity; Overweight

• Registration Number: NCT00455780
• Lead Sponsor: Drexel University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2007-04-03
• Study First Submitted QC: 2007-04-03
• Study First Posted: 2007-04-04
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-24
• Last Update Posted: 2011-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Weight	baseline, 3 months, 12 months, 24 months, 36 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States