Weight Loss Treatment for Veterans With Binge Eating
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
109 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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