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Environmental and Acceptance-Based Innovations for Weight Loss Maintenance (ENACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01858714
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):

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
Obesity Overweight Weight Loss Behavioral: Behavior Therapy for Weight Loss Behavioral: Behavior Therapy + Environment Behavioral: Acceptance-based Behavior Therapy + Environment

Study Design

Study Type : Interventional  (Clinical Trial)
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 : September 2011
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.


Outcome Measures

Primary Outcome Measures :
  1. Change in Body Weight [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ]
  2. Change in Physical Activity [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ]
    Objectively measured physical activity will be recorded at each time point.

  3. Change in Nutritional Intake [ Time Frame: Baseline, 12 months, 24 months ]
    Measured by 24-hour food recall

  4. Change in Psychosocial Status [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858714


Locations
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Meghan Butryn, Ph.D., Drexel University
ClinicalTrials.gov Identifier: NCT01858714     History of Changes
Other Study ID Numbers: R01DK092374 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016

Keywords provided by Meghan Butryn, Drexel University:
obesity
overweight
weight loss

Additional relevant MeSH terms:
Body Weight
Overweight
Weight Loss
Signs and Symptoms
Body Weight Changes