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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meghan Butryn, Drexel University
ClinicalTrials.gov Identifier:
NCT01858714
First received: June 19, 2012
Last updated: August 3, 2016
Last verified: August 2016
  Purpose
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 Intervention
Obesity Overweight Weight Loss Behavioral: Behavior Therapy for Weight Loss Behavioral: Behavior Therapy + Environment Behavioral: Acceptance-based Behavior Therapy + Environment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

Resource links provided by NLM:


Further study details as provided by Meghan Butryn, Drexel University:

Primary Outcome Measures:
  • Change in Body Weight [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ]
  • 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.

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

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

Enrollment: 238
Study Start Date: September 2011
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: June 19, 2012
Last Updated: August 3, 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

ClinicalTrials.gov processed this record on July 27, 2017