ENACT: Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

Sponsor

Drexel University (Other)

Overall Status

Completed

CT.gov ID

NCT01858714

Collaborator

(none)

238

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Weight Loss	Behavioral: Behavior Therapy for Weight Loss Behavioral: Behavior Therapy + Environment Behavioral: Acceptance-based Behavior Therapy + Environment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

238 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Behavior Therapy (BT) 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 Standard behavioral treatment for weight loss and weight loss maintenance.
Experimental: Behavior Therapy + Environment Participants will receive standard behavioral therapy with an emphasis on environmental strategies.	Behavioral: Behavior Therapy + Environment Standard behavioral therapy with an emphasis on environmental strategies.
Experimental: Acceptance-based BT + Environment Participants will receive acceptance-based behavioral therapy with an emphasis on environmental strategies.	Behavioral: Acceptance-based Behavior Therapy + Environment Behavioral therapy with acceptance-based and environmental strategies.

Arm

Intervention/Treatment

Active Comparator: Behavior Therapy (BT)

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

Standard behavioral treatment for weight loss and weight loss maintenance.

Experimental: Behavior Therapy + Environment

Participants will receive standard behavioral therapy with an emphasis on environmental strategies.

Behavioral: Behavior Therapy + Environment

Standard behavioral therapy with an emphasis on environmental strategies.

Experimental: Acceptance-based BT + Environment

Participants will receive acceptance-based behavioral therapy with an emphasis on environmental strategies.

Behavioral: Acceptance-based Behavior Therapy + Environment

Behavioral therapy with acceptance-based and environmental strategies.

Outcome Measures

Primary Outcome Measures

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 Nutritional Intake [Baseline, 12 months, 24 months]
Measured by 24-hour food recall
Change in Psychosocial Status [Baseline, 6 months, 12 months, 18 months, 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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