NCT01854320

Brief Summary

The primary goal of this project is to determine if an innovative behavioral weight loss program that incorporates new developments from the field of behavior therapy produces superior weight control than standard behavioral treatment. A sample of 200 adults from the community are participating in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

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

July 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

5.9 years

First QC Date

May 14, 2013

Last Update Submit

August 14, 2018

Conditions

Acceptance-based TreatmentStandard Behavioral Treatment

Outcome Measures

Primary Outcomes (1)

  • Weight

    Baseline - 2-year follow-up

Study Arms (2)

Acceptance-based treatment

EXPERIMENTAL

Behavioral therapy for weight loss focusing on acceptance-based cognitive strategies and techniques.

Behavioral: Acceptance-based treatment

Standard behavioral treatment

ACTIVE COMPARATOR

Standard behavioral therapy for weight loss, the "gold standard" treatment.

Behavioral: Standard behavioral treatment

Interventions

Acceptance-based treatmentBEHAVIORAL
Acceptance-based treatment
Standard behavioral treatmentBEHAVIORAL
Standard behavioral treatment

Eligibility Criteria

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

You may qualify if:

  • Be between the ages of 18 and 70
  • Have a BMI between 27-50
  • Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest).
  • Agree to provide permission for the research team to regularly contact your physician throughout the study to share information on changes in your weight.
  • Successfully complete all steps in the enrollment process

You may not qualify if:

  • You have a medical condition or psychiatric condition that may limit your ability to comply with the behavioral recommendations of the program or pose a risk to you during weight loss.
  • You are pregnant or plan to become pregnant in the next three years.
  • Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain.
  • You are participating in or plan to participate in another weight loss program in the next three years.
  • The research team identifies any factors that would render you potentially unable or unlikely to follow the protocol, or unable to benefit from it.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (5)

  • 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.

    PMID: 40705619DERIVED

  • Crochiere RJ, Kerrigan SG, Lampe EW, Manasse SM, Crosby RD, Butryn ML, Forman EM. Is physical activity a risk or protective factor for subsequent dietary lapses among behavioral weight loss participants? Health Psychol. 2020 Mar;39(3):240-244. doi: 10.1037/hea0000839. Epub 2020 Jan 9.

    PMID: 31916827DERIVED

  • Godfrey KM, Schumacher LM, Butryn ML, Forman EM. Physical Activity Intentions and Behavior Mediate Treatment Response in an Acceptance-Based Weight Loss Intervention. Ann Behav Med. 2019 Nov 9;53(12):1009-1019. doi: 10.1093/abm/kaz011.

    PMID: 30951589DERIVED

  • 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.

    PMID: 29442440DERIVED

  • 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.

    PMID: 25106049DERIVED

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
Principal Investigator

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 15, 2013

Study Start

July 1, 2012

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

US(1)