Weight Loss Treatment for Veterans With Binge Eating

NCT03234881 | Completed Results

• 1 other identifier: IIR 15-349
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Binge Eating Disorder

Keywords

Binge Eating; Cognitive Behavioral Therapy; Weight Management; Veterans

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in Patient Health Questionnaire-9 (PHQ-9)

  Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

• Change in PTSD Checklist (PCL-5)

  Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

• Weight and Eating Quality of Life (WE-QoL)

  Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

• Change in European Quality of Life (EuroQoL-5D)

  Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

• Night Eating Questionnaire (NEQ)

  Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

Other Outcomes (7)

• Change in BMI

  Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

• Change in Weight Control Strategies Scale (WCSS)

  Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

• Change in Godin Leisure Time Exercise Questionnaire (Godin)

  Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

Study Arms (2)

MOVE!

ACTIVE COMPARATOR

Weight management delivered as Treatment-as-Usual

Behavioral: MOVE!

MOVE!+CBT

EXPERIMENTAL

Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.

Behavioral: MOVE!+CBT

Interventions

MOVE! BEHAVIORAL

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.

MOVE!

MOVE!+CBT BEHAVIORAL

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.

MOVE!+CBT

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

Location

Related Publications (5)

• 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.

  PMID: 28271431 BACKGROUND

• 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.

  PMID: 32107681 RESULT

• 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.

  PMID: 36973571 RESULT

• 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.

  PMID: 37200510 RESULT

• 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 Sep;58(9):1777-1792. doi: 10.1002/eat.24476. Epub 2025 Jun 9.

  PMID: 40485646 RESULT

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robin Masheb, PhD
• Organization: VA Connecticut Healthcare System

Robin.Masheb@va.gov

203-932-5711

Study Officials

• Robin M Masheb, PhD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Treating therapists will be blind to outcome data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a randomized RCT in which one half of participants will be assigned to MOVE! (treatment-as-usual weight management) and the other half will be assigned to MOVE! plus the experimental condition (clinician-led Cognitive Behavioral Therapy).

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 31, 2017
• Study Start: January 8, 2018
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: July 9, 2025
• Results First Posted: June 28, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)