Weight Loss Treatment for Veterans With Binge Eating

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: Completed
• Conditions: Binge Eating Disorder
• Intervention / Treatment: Behavioral: MOVE!; Behavioral: MOVE!+CBT

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: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)	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	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

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire-9 (PHQ-9)	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)	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)	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)	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)	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)	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

Outcome Measure	Measure Description	Time Frame
Change in BMI	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)	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)	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	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	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)	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)	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

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Robin M Masheb, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Publications and helpful links

General Publications

• Masheb RM, Chan SH, Raffa SD, Ackermann R, Damschroder LJ, Estabrooks PA, Evans-Hudnall G, Evans NC, Histon T, Littman AJ, Moin T, Nelson KM, Pagoto S, Pronk NP, Tate DF, Goldstein MG. State of the art conference on weight management in VA: Policy and research recommendations for advancing behavioral interventions. J Gen Intern Med. 2017 Apr;32(Suppl 1):74-78. doi: 10.1007/s11606-016-3965-y.
• Masheb RM, Douglas ME, Kutz AM, Marsh AG, Driscoll M. Pain and emotional eating: further investigation of the Yale Emotional Overeating Questionnaire in weight loss seeking patients. J Behav Med. 2020 Jun;43(3):479-486. doi: 10.1007/s10865-020-00143-4. Epub 2020 Feb 27.
• Masheb RM, Snow JL, Fenn LM, Antoniadis NE, Raffa SD, Ruser CB, Buta E. Development and Psychometric Assessment of the Weight and Eating Quality of Life (WE-QOL) Scale in US Military Veterans. J Gen Intern Med. 2023 Jul;38(9):2076-2081. doi: 10.1007/s11606-023-08132-4. Epub 2023 Mar 27.
• Carr MM, Lou R, Macdonald-Gagnon G, Peltier MR, Funaro MC, Martino S, Masheb RM. Weight change among patients engaged in medication treatment for opioid use disorder: a scoping review. Am J Drug Alcohol Abuse. 2023 Sep 3;49(5):551-565. doi: 10.1080/00952990.2023.2207720. Epub 2023 May 18.
• Masheb RM, Buta E, Snow JL, Munro LF, Lawless M, Abel EA, McWain NE, Marsh A, Cary A, Grilo CM, Raffa SD, Ruser CB. Randomized Controlled Trial of Weight Management Versus Weight Management With Concurrent Cognitive-Behavioral Therapy for Binge-Eating Disorder in US Veterans With High Weight. Int J Eat Disord. 2025 Jun 9. doi: 10.1002/eat.24476. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Veterans; Cognitive Behavioral Therapy; Binge Eating; Weight Management
• Additional Relevant MeSH Terms: Mental Disorders; Body Weight; Hyperphagia; Signs and Symptoms, Digestive; Body Weight Changes; Bulimia; Weight Loss; Binge-Eating Disorder; Feeding and Eating Disorders
• Other Study ID 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