Weight Loss Treatment for Veterans With Binge Eating

July 1, 2025 updated by: VA Office of Research and Development

Weight Loss Treatment and CBT for Veterans With Binge Eating

This study aims to adapt and test a cognitive behavioral therapy (CBT) treatment that can be administered concurrently with the Veteran's Health Administration (VHA) MOVE! weight management program for Veterans with DSM-5 Binge Eating Disorder (BED) and high weight.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To date, there have been limited studies of Binge Eating Disorder (BED) and high weight utilizing combined eating disorder and weight management approaches in real-world settings, nor studies with complex and diverse samples. The objective of this project was to conduct a clinical trial that would produce evidence-based findings for a diverse patient group in a healthcare setting. Specifically, we aimed to address comorbid BED and high weight among Veterans in the Veteran's Health Administration (VHA), the largest integrated healthcare system in the U.S., by testing the effectiveness of VA's evidence-based weight management program, called MOVE!, versus MOVE! administered concurrent with a brief, clinician-led cognitive-behavioral therapy (CBT).

Aim 1: To assess the effectiveness of MOVE! (treatment-as-usual) to MOVE! plus brief, clinician-led CBT (MOVE!+CBT).

Hypothesis 1: It is hypothesized that MOVE!+CBT will have greater improvements on the primary outcomes of eating pathology and binge eating (reductions in binge frequency and percentage of participants who are binge remitted) than MOVE! alone.

Hypothesis 2: It is further hypothesized that MOVE!+CBT will have greater improvements on secondary measures of mental health, quality of life, and other eating behaviors.

Aim 2: To conduct exploratory analyses assessing the effectiveness of MOVE! to MOVE! vs. MOVE!+CBT on weight outcomes.

Hypothesis: It is hypothesized that MOVE!+CBT will have greater weight loss, and a larger percentage who achieve 5% weight loss, than MOVE! alone.

Note that several planned outcomes were not able to be analyzed for this project. Due to pandemic/COVID-19 related impacts, lipid profile data from in-person blood draws were inconsistently collected. Likewise, MOVE! adherence could not be measured with in-person session attendance as delivery for this intervention was expanded to include technology-delivered modalities. To fill these gaps, an "Impact of COVID-19" measure was added soon after the onset of the pandemic, but these questionnaire items did not hold up over the course of time and were removed. Finally, the 24-Hour Food Frequency Questionnaire (24 Hour-FFQ), a brief screening tool of food intake, was a measure specially designed for this study. Validation and publication of this screener was successful (The 24-hour food frequency assessment screening tool (FAST24): Development and evaluation of a novel dietary screener to identify foods associated with weight change - PubMed (nih.gov)), however, the lack of granular dietary data did not lend itself to measuring outcome. None of the measures removed represented primary or secondary outcomes for this project.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Connecticut
      • West Haven, Connecticut, United States, 06516-2770
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Massachusetts
      • Leeds, Massachusetts, United States, 01053-9764
        • VA Central Western Massachusetts Healthcare System, Leeds, MA

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI>=25
  • Presence of recurrent binge eating on the MOVE! Survey

Exclusion Criteria:

  • More than 4 MOVE! sessions in the prior year
  • Active psychosis or suicidal ideation
  • Medical or psychiatric illness, or cognitive deficits that interfere with providing consent or completing assessments
  • Pregnancy or lactation

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: MOVE!
Weight management delivered as Treatment-as-Usual
Behavioral: MOVE!
Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. *TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
Experimental: MOVE!+CBT
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
Behavioral: MOVE!+CBT
Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)
Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The EDE-Q is the self-report version of the more intensive EDE interview. Research has documented that the EDE-Q performs well as a measure of change in treatment trials and has adequate convergence with the interview format. The EDE-Q generates the same frequency data for eating behaviors (binge eating and overeating) in the past 28 days, and the same four subscales reflecting eating disorder pathology. Score on a scale 0-6; higher=worse
Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Change in Binge Episodes From Eating Disorder Examination Interview
Time Frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The EDE is a clinician administered interview that is considered to be the gold standard for diagnosing eating disorders and assessing binge frequency. Number of binges; higher=worse
Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The PHQ-9 is a 9-item version, is a self-report measure for the symptoms of depression. Score on scale from 0-27; higher=worse
Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Change in PTSD Checklist (PCL-5)
Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of Post Traumatic Stress Disorder (PTSD). Score on scale from 0-80; higher=worse
Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Weight and Eating Quality of Life (WE-QoL)
Time Frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The WE-QoL is an 8-item self-report instrument for measurement of the impact weight and eating has on quality-of-life outcomes. Score on scale from 0-4; higher=worse
Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Change in European Quality of Life (EuroQoL-5D)
Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The EuroQol-5D is a 5-item self-report instrument for measurement of quality of life outcomes that has specifically been used in weight loss trials with Veterans. The EuroQoL-5D also includes the Visual Analogue Scale (VAS) which is a measure of overall self-rated health status on a 100-point scale. Units on a scale (0-100); higher=better
Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Night Eating Questionnaire (NEQ)
Time Frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The NEQ is a 14-item self-report instrument for the measurement of Night Eating Syndrome (NES). A total score of greater than or equal to 25 indicates NES. Score on scale 0-52; higher=worse
Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
CBT Session Attendance (Treatment Dose)
Time Frame: 3 month post-treatment
CBT session attendance will be determined by the number of clinician-led individual sessions attended throughout the treatment.
3 month post-treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in BMI
Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
BMI will be calculated based upon self-reported height and weight. A BMI of 25.0-29.9 indicates overweight, and 30.0 above indicates obesity. Kg/m 2; higher=worse
Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Change in Weight Control Strategies Scale (WCSS)
Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The WCSS is a self-report instrument that assesses the use of specific weight loss behaviors. The measure has been shown to be valid, reliable and predictive of weight loss. Score on a scale 0-4; higher=better
Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Change in Godin Leisure Time Exercise Questionnaire (Godin)
Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The Godin is a 4-item, reliable self-report measure of physical activity that assesses the frequencies of strenuous, moderate and mild exercise and has been validated against accelerometers. Units on a scale 0-119; higher=better
Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Treatment Satisfaction
Time Frame: 3 months post treatment
Treatment satisfaction will be measured with a number of questions to measure participants' experience as a participant on a range from strongly disagree to strongly agree (e.g., "I increased my ability to manage my binge eating" and "How likely are you to recommend this treatment to other Veterans?"). Score on a scale 0-48; higher=better
3 months post treatment
Change in Weight
Time Frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
All weights were taken by self-report at each timepoint.
Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Loss of Control Overeating Scale (LOCES)
Time Frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
A self-administered scale used to assess features of loss of control over eating. Score on a scale 0-4; higher=worse
Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Time Frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
A self-administered scale used to assess the features of food addiction. Units on a scale 0-11; higher=worse
Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robin M Masheb, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIR 15-349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Unable to share Veteran data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Binge Eating Disorder

Clinical Trials on MOVE!

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings