Skip to main content
OpenTrials
Completed

NCT Number: NCT03234881

Weight Loss Treatment 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Binge Eating Disorder Binge-Eating Disorder Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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!+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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Weight Loss Treatment and CBT for Veterans With Binge Eating

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 31, 2017
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.