Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

Not Applicable

Completed

• Conditions: Weight Loss; Overweight; Obesity
• Interventions: Behavioral: Behavior Therapy + Environment; Behavioral: Acceptance-based Behavior Therapy + Environment; Behavioral: Behavior Therapy for Weight Loss

• Registration Number: NCT01858714
• Lead Sponsor: Drexel University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-21
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

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

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavior Therapy + Environment	Behavior Therapy + Environment	Participants will receive standard behavioral therapy with an emphasis on environmental strategies.
Acceptance-based BT + Environment	Acceptance-based Behavior Therapy + Environment	Participants will receive acceptance-based behavioral therapy with an emphasis on environmental strategies.
Behavior Therapy (BT)	Behavior Therapy for Weight Loss	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States