Weight Loss Treatment for Veterans With Binge Eating

Not Applicable

Completed

• Conditions: Binge Eating Disorder
• Interventions: Behavioral: MOVE!; Behavioral: MOVE!+CBT

• Registration Number: NCT03234881
• Lead Sponsor: VA Office of Research and Development

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.

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 Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-31
• Study Start: 2018-01-08
• Primary Completion: 2023-05-23
• Study Completion: 2023-05-23
• Status Verified: 2024-06
• Results First Submitted: 2024-06-04
• Results First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Results First Posted: 2024-06-28
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOVE!	MOVE!	Weight management delivered as Treatment-as-Usual
MOVE!+CBT	MOVE!+CBT	Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.

Primary Outcome Measures

Name	Time	Method
Change in Binge Episodes From Eating Disorder Examination Interview	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
Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)	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

Secondary Outcome Measures

Name	Time	Method
Change in European Quality of Life (EuroQoL-5D)	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
Change in Patient Health Questionnaire-9 (PHQ-9)	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
Change in PTSD Checklist (PCL-5)	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
Weight and Eating Quality of Life (WE-QoL)	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
Night Eating Questionnaire (NEQ)	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
CBT Session Attendance (Treatment Dose)	3 month post-treatment	CBT session attendance will be determined by the number of clinician-led individual sessions attended throughout the treatment.

Trial Locations

Locations (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

VA Central Western Massachusetts Healthcare System, Leeds, MA; 🇺🇸 Leeds, Massachusetts, United States