Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

Study Overview
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Brief Summary
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The major goal of this project is to evaluate an innovative approach to obesity involving modification of the home environment. The project also will evaluate if home environment modification is more effective when supplemented with distress tolerance and related skills training.

Official Title
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Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

Conditions
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Obesity, Overweight, Weight Loss

Intervention / Treatment
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* Behavioral: Behavior Therapy for Weight Loss
* Behavioral: Behavior Therapy + Environment
* Behavioral: Acceptance-based Behavior Therapy + Environment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a BMI between 27 and 45 kg/m2 Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest) Successfully complete all steps in the enrollment process, including completion of a 7-day food diary and attendance at all pre-randomization clinic visits Exclusion Criteria: Have a medical condition (e.g., cancer) or psychiatric condition (e.g., psychotic disorder, substance dependence, bulimia nervosa) that may limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss Are pregnant or plan to become pregnant in next 2 years Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain Are participating in or plan to participate in another weight loss program in the next 2 years

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Behavior Therapy (BT)<br>Active Comparator: Behavior Therapy Behavioral treatment strategies will be utilized to facilitate adherence to the treatment goals in all three treatments. Participants in the BT condition will receive only the BT intervention. Strategies that will be emphasized are listed below: Self monitoring Stimulus control Changing eating behaviors Goal setting Problem solving Social support Cognitive restructuring Relapse prevention | Behavioral: Behavior Therapy for Weight Loss<br>* Standard behavioral treatment for weight loss and weight loss maintenance.<br>|
| Experimental: Behavior Therapy + Environment<br>Participants will receive standard behavioral therapy with an emphasis on environmental strategies. | Behavioral: Behavior Therapy + Environment<br>* Standard behavioral therapy with an emphasis on environmental strategies.<br>|
| Experimental: Acceptance-based BT + Environment<br>Participants will receive acceptance-based behavioral therapy with an emphasis on environmental strategies. | Behavioral: Acceptance-based Behavior Therapy + Environment<br>* Behavioral therapy with acceptance-based and environmental strategies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight |  | Baseline, 6 months, 12 months, 18 months, 24 months | 
| Change in Physical Activity | Objectively measured physical activity will be recorded at each time point. | Baseline, 6 months, 12 months, 18 months, 24 months | 
| Change in Nutritional Intake | Measured by 24-hour food recall | Baseline, 12 months, 24 months | 
| Change in Psychosocial Status |  | Baseline, 6 months, 12 months, 18 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight, weight loss