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CompletedNCT01858714ENACTUpdated Aug 5, 2016

Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

An interventional study of Behavior Therapy for Weight Loss and Behavior Therapy + Environment in Obesity, Overweight and Weight Loss, sponsored by Drexel University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-05.

Sponsored by Drexel University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
238
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight
  • Weight Loss

Keywords

  • obesity
  • overweight
  • weight loss
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's enrollment of 238 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Drexel University is the lead sponsor of 110 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
238 participants (actual)

Study arms

  • 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

  • Experimental
    Behavior Therapy + Environment

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

    Behavioral: Behavior Therapy + Environment

  • Experimental
    Acceptance-based BT + Environment

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

    Behavioral: Acceptance-based Behavior Therapy + Environment

Interventions

  • BehavioralBehavior Therapy for Weight Loss

    Standard behavioral treatment for weight loss and weight loss maintenance.

  • BehavioralBehavior Therapy + Environment

    Standard behavioral therapy with an emphasis on environmental strategies.

  • BehavioralAcceptance-based Behavior Therapy + Environment

    Behavioral therapy with acceptance-based and environmental strategies.

06

What researchers measure

Primary outcomes

  1. Change in Body Weight

    Time frame: Baseline, 6 months, 12 months, 18 months, 24 months

  2. Change in Physical Activity

    Objectively measured physical activity will be recorded at each time point.

    Time frame: Baseline, 6 months, 12 months, 18 months, 24 months

  3. Change in Nutritional Intake

    Measured by 24-hour food recall

    Time frame: Baseline, 12 months, 24 months

  4. Change in Psychosocial Status

    Time frame: Baseline, 6 months, 12 months, 18 months, 24 months

07

Study locations

1 site
  • Drexel University
    Philadelphia, Pennsylvania 19102, United States
08

References and documents

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. PubMed 29442440 ↗
  • 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. PubMed 28337847 ↗
  • 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. PubMed 25106049 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01858714
Lead sponsor
Drexel University
Responsible party
Meghan Butryn (Ph.D., Drexel University) — Principal investigator
First posted
May 21, 2013
Start date
Sep 2011
Primary completion
May 2016
Completion
May 2016
Last update
Aug 5, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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