Acceptance-based Behavioral Treatment for Obesity: Maintenance and Mechanisms (MYH-II)

August 14, 2018 updated by: Evan Forman, Drexel University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Acceptance-based treatment
Behavioral therapy for weight loss focusing on acceptance-based cognitive strategies and techniques.
Behavioral: Acceptance-based treatment
Active Comparator: Standard behavioral treatment
Standard behavioral therapy for weight loss, the "gold standard" treatment.
Behavioral: Standard behavioral treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: Baseline - 2-year follow-up
Baseline - 2-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drexel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DK095069 (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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