- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01858714
Environmental and Acceptance-Based Innovations for Weight Loss Maintenance (ENACT)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19102
- Drexel University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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 |
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.
|
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 therapy with acceptance-based and environmental strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Weight
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
|
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.
|
Baseline, 6 months, 12 months, 18 months, 24 months
|
Change in Nutritional Intake
Time Frame: Baseline, 12 months, 24 months
|
Measured by 24-hour food recall
|
Baseline, 12 months, 24 months
|
Change in Psychosocial Status
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
|
Baseline, 6 months, 12 months, 18 months, 24 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Butryn ML, Call CC, Schumacher LM, Kerrigan SG, Forman EM. Time to Peak Weight Loss During Extended Behavioral Treatment. Obesity (Silver Spring). 2018 Apr;26(4):658-664. doi: 10.1002/oby.22127. Epub 2018 Feb 14.
- Butryn ML, Arigo D, Raggio GA, Kaufman AI, Kerrigan SG, Forman EM. Measuring the Ability to Tolerate Activity-Related Discomfort: Initial Validation of the Physical Activity Acceptance Questionnaire (PAAQ). J Phys Act Health. 2015 May;12(5):717-6. doi: 10.1123/jpah.2013-0338. Epub 2014 Aug 7.
- Butryn ML, Forman EM, Lowe MR, Gorin AA, Zhang F, Schaumberg K. Efficacy of environmental and acceptance-based enhancements to behavioral weight loss treatment: The ENACT trial. Obesity (Silver Spring). 2017 May;25(5):866-872. doi: 10.1002/oby.21813. Epub 2017 Mar 23.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK092374 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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