Weight Loss Maintenance in Primary Care

Study Overview
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Brief Summary
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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.

Official Title
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Weight Loss Maintenance in Primary Care

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Weight Loss Phase
* Behavioral: Continued CBT
* Behavioral: reduced energy density education
* Behavioral: continued use of meal replacements


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR-/REDE-<br>Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance. | Behavioral: Weight Loss Phase<br>* Weight loss using CBT and meal replacements<br>Behavioral: Continued CBT<br>* Using CBT during weight loss maintenance<br>|
| Experimental: MR+/REDE-<br>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<br>* Weight loss using CBT and meal replacements<br>Behavioral: Continued CBT<br>* Using CBT during weight loss maintenance<br>Behavioral: continued use of meal replacements<br>* continued use of meal replacements during weight loss maintenance<br>|
| Experimental: MR-/REDE+<br>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<br>* Weight loss using CBT and meal replacements<br>Behavioral: Continued CBT<br>* Using CBT during weight loss maintenance<br>Behavioral: reduced energy density education<br>* Additional nutritional learning<br>|
| Experimental: MR+/REDE+<br>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<br>* Weight loss using CBT and meal replacements<br>Behavioral: Continued CBT<br>* Using CBT during weight loss maintenance<br>Behavioral: reduced energy density education<br>* Additional nutritional learning<br>Behavioral: continued use of meal replacements<br>* continued use of meal replacements during weight loss maintenance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | baseline, 3 months, 12 months, 24 months, 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eating, Dieting, Meal replacements, Energy Density, Weight Loss Maintenance