Weight Loss Maintenance in Primary Care

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Behavioral: Weight Loss Phase; Behavioral: Continued CBT; Behavioral: continued use of meal replacements; Behavioral: reduced energy density education

• 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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
MR-/REDE-	Weight Loss Phase	Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance.
MR-/REDE-	Continued CBT	Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance.
MR+/REDE-	Weight Loss Phase	Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance.
MR+/REDE-	Continued CBT	Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance.
MR+/REDE-	continued use of meal replacements	Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance.
MR-/REDE+	Weight Loss Phase	Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance.
MR-/REDE+	Continued CBT	Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance.
MR-/REDE+	reduced energy density education	Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance.
MR+/REDE+	Weight Loss Phase	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.
MR+/REDE+	Continued CBT	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.
MR+/REDE+	reduced energy density education	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.
MR+/REDE+	continued use of meal replacements	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.

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