search
Back to results

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

Primary Purpose

Obesity, Overweight, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavior Therapy for Weight Loss
Behavior Therapy + Environment
Acceptance-based Behavior Therapy + Environment
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, overweight, weight loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Drexel University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Behavior Therapy (BT)

Behavior Therapy + Environment

Acceptance-based BT + Environment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Body Weight
Change in Physical Activity
Objectively measured physical activity will be recorded at each time point.
Change in Nutritional Intake
Measured by 24-hour food recall
Change in Psychosocial Status

Secondary Outcome Measures

Full Information

First Posted
June 19, 2012
Last Updated
August 3, 2016
Sponsor
Drexel University
search

1. Study Identification

Unique Protocol Identification Number
NCT01858714
Brief Title
Environmental and Acceptance-Based Innovations for Weight Loss Maintenance
Acronym
ENACT
Official Title
Environmental and Acceptance-Based Innovations for Weight Loss Maintenance
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Weight Loss
Keywords
obesity, overweight, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavior Therapy (BT)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Behavior Therapy + Environment
Arm Type
Experimental
Arm Description
Participants will receive standard behavioral therapy with an emphasis on environmental strategies.
Arm Title
Acceptance-based BT + Environment
Arm Type
Experimental
Arm Description
Participants will receive acceptance-based behavioral therapy with an emphasis on environmental strategies.
Intervention Type
Behavioral
Intervention Name(s)
Behavior Therapy for Weight Loss
Intervention Description
Standard behavioral treatment for weight loss and weight loss maintenance.
Intervention Type
Behavioral
Intervention Name(s)
Behavior Therapy + Environment
Intervention Description
Standard behavioral therapy with an emphasis on environmental strategies.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance-based Behavior Therapy + Environment
Intervention Description
Behavioral therapy with acceptance-based and environmental strategies.
Primary Outcome Measure Information:
Title
Change in Body Weight
Time Frame
Baseline, 6 months, 12 months, 18 months, 24 months
Title
Change in Physical Activity
Description
Objectively measured physical activity will be recorded at each time point.
Time Frame
Baseline, 6 months, 12 months, 18 months, 24 months
Title
Change in Nutritional Intake
Description
Measured by 24-hour food recall
Time Frame
Baseline, 12 months, 24 months
Title
Change in Psychosocial Status
Time Frame
Baseline, 6 months, 12 months, 18 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29442440
Citation
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.
Results Reference
derived
PubMed Identifier
28337847
Citation
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.
Results Reference
derived
PubMed Identifier
25106049
Citation
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.
Results Reference
derived

Learn more about this trial

Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

We'll reach out to this number within 24 hrs