Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches

Study Overview
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Brief Summary
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The purpose of this study is to examine the effectiveness of 3 behavioral weight loss programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined approach which includes university-based treatment followed by Weight Watchers.

Official Title
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Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Standard behavioral weight loss treatment
* Behavioral: Weight Watchers
* Behavioral: Combined Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 30-65 years BMI between 27-50 kg/m2 Written approval/consent from primary health care provider Exclusion Criteria: Unable to walk 2 blocks without stopping. Currently participating in a weight loss program or taking weight loss medication. Participated in a weight loss program in the last year Took weight loss medication in the last 6 months. Participated in Weight Watchers in last 2 years. Lost >=5% of body weight during 6 months prior to screening. Pregnant, lactating, less than 6 months postpartum, or plan to become pregnant during study time frame. Report conditions that in the judgment of the principal investigator would render them potentially unlikely to follow protocol for the 12 month study. Report a medical condition that would affect the safety and/or efficacy of a weight management program involving changes in diet and physical activity.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard behavioral weight loss<br>University-based behavioral weight loss treatment | Behavioral: Standard behavioral weight loss treatment<br>* Participants will receive 12 months of university-based behavioral weight loss treatment<br>|
| Active Comparator: Weight Watchers<br>Weight Watchers program | Behavioral: Weight Watchers<br>* Participants will receive 12 months of Weight Watchers<br>|
| Active Comparator: Combined Treatment<br>University-based behavioral weight loss treatment followed by Weight Watchers | Behavioral: Combined Treatment<br>* Participants will receive university-based behavioral weight loss treatment followed by Weight Watchers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 3, 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost-effectiveness |  | 12 months |