Clinical trial NCT03234881: Weight Loss Treatment for Veterans With Binge Eating
Official title: Weight Loss Treatment and CBT for Veterans With Binge Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating Disorder
Keywords: Binge Eating
Cognitive Behavioral Therapy
Weight Management
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-07-31
Enrollment: 109
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)
timeFrame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
measure: Change in Binge Episodes From Eating Disorder Examination Interview
timeFrame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Secondary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
measure: Change in PTSD Checklist (PCL-5)
timeFrame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
measure: Weight and Eating Quality of Life (WE-QoL)
timeFrame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
measure: Change in European Quality of Life (EuroQoL-5D)
timeFrame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
measure: Night Eating Questionnaire (NEQ)
timeFrame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
measure: CBT Session Attendance (Treatment Dose)
timeFrame: 3 month post-treatment
Other outcomes:
measure: Change in BMI
timeFrame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
measure: Change in Weight Control Strategies Scale (WCSS)
timeFrame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
measure: Change in Godin Leisure Time Exercise Questionnaire (Godin)
timeFrame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
measure: Treatment Satisfaction
timeFrame: 3 months post treatment
measure: Change in Weight
timeFrame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
measure: Loss of Control Overeating Scale (LOCES)
timeFrame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
measure: Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
timeFrame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Leeds
country: United States
facility: VA Central Western Massachusetts Healthcare System, Leeds, MA
state: Massachusetts
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Robin M Masheb, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.