NCT01858714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

4.7 years

First QC Date

June 19, 2012

Last Update Submit

August 3, 2016

Conditions

Keywords

obesityoverweightweight loss

Outcome Measures

Primary Outcomes (4)

  • Change in Body Weight

    Baseline, 6 months, 12 months, 18 months, 24 months

  • Change in Physical Activity

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

    Baseline, 6 months, 12 months, 18 months, 24 months

  • Change in Nutritional Intake

    Measured by 24-hour food recall

    Baseline, 12 months, 24 months

  • Change in Psychosocial Status

    Baseline, 6 months, 12 months, 18 months, 24 months

Study Arms (3)

Behavior Therapy (BT)

ACTIVE COMPARATOR

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

Behavior Therapy + Environment

EXPERIMENTAL

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

Behavioral: Behavior Therapy + Environment

Acceptance-based BT + Environment

EXPERIMENTAL

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

Behavioral: Acceptance-based Behavior Therapy + Environment

Interventions

Standard behavioral treatment for weight loss and weight loss maintenance.

Behavior Therapy (BT)

Standard behavioral therapy with an emphasis on environmental strategies.

Behavior Therapy + Environment

Behavioral therapy with acceptance-based and environmental strategies.

Acceptance-based BT + Environment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (4)

  • Chabria R, Hagerman CJ, Crane N, Ehmann M, Knudsen FM, Brown KL, Forman E, Butryn ML. Racial disparities in the efficacy of traditional versus acceptance-based behavioral weight loss. Health Psychol. 2025 Jul 24:10.1037/hea0001537. doi: 10.1037/hea0001537. Online ahead of print.

  • 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, 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.

  • 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.

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Interventions

Behavior TherapyEnvironment

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

June 19, 2012

First Posted

May 21, 2013

Study Start

September 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-08

Locations