Weight Loss Treatment for Veterans With Binge Eating

Weight Loss Treatment and CBT for Veterans With Binge Eating

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03234881

Enrollment

109

Registered

2017-07-31

Start date

2018-01-08

Completion date

2023-05-23

Last updated

2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating Disorder

Keywords

Binge Eating, Cognitive Behavioral Therapy, Weight Management, Veterans

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.

Interventions

BEHAVIORALMOVE!

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.

BEHAVIORALMOVE!+CBT

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Masking description

Treating therapists will be blind to outcome data

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).

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy 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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Secondary

Measure	Time frame	Description
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
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
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.

Other

Measure	Time frame	Description
Change in Weight Control Strategies Scale (WCSS)	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
Change in Godin Leisure Time Exercise Questionnaire (Godin)	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
Treatment Satisfaction	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
Change in Weight	Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment	All weights were taken by self-report at each timepoint.
Loss of Control Overeating Scale (LOCES)	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
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)	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
Change in BMI	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

Countries

United States

Participant flow

Participants by arm

Arm	Count
MOVE! Weight management delivered as Treatment-as-Usual MOVE!: 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.	56
MOVE!+CBT Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating. MOVE!+CBT: 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.	53
Total	109

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	9	3

Baseline characteristics

Characteristic	Total	MOVE!+CBT	MOVE!
Age, Continuous	55.8 years STANDARD_DEVIATION 12.3	57.9 years STANDARD_DEVIATION 10.5	53.8 years STANDARD_DEVIATION 13.5
Education Completed College	31 Participants	14 Participants	17 Participants
Education Graduate School	16 Participants	11 Participants	5 Participants
Education >High School/High School	19 Participants	12 Participants	7 Participants
Education Some College	43 Participants	16 Participants	27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants	5 Participants	8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	96 Participants	48 Participants	48 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Married	57 Participants	29 Participants	28 Participants
Mental Health Alcohol Use Disorder (Positive AUDIT-C)	24 Participants	10 Participants	14 Participants
Mental Health Trauma (Positive PCL Criteria A)	80 Participants	40 Participants	40 Participants
Race/Ethnicity, Customized Asian	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Black	11 Participants	6 Participants	5 Participants
Race/Ethnicity, Customized More than one race/race not listed	5 Participants	2 Participants	3 Participants
Race/Ethnicity, Customized White	91 Participants	44 Participants	47 Participants
Sex/Gender, Customized Sex/Gender Female	27 Participants	16 Participants	11 Participants
Sex/Gender, Customized Sex/Gender Male	81 Participants	36 Participants	45 Participants
Sex/Gender, Customized Sex/Gender Other, not specified	1 Participants	1 Participants	0 Participants
Weight History Baseline Weight	254 lbs STANDARD_DEVIATION 52	249 lbs STANDARD_DEVIATION 54	258 lbs STANDARD_DEVIATION 50.2
Weight History Highest Adult Weight	272 lbs STANDARD_DEVIATION 54.2	266 lbs STANDARD_DEVIATION 55.4	278 lbs STANDARD_DEVIATION 52.9
Weight History Lowest Adult Weight	168 lbs STANDARD_DEVIATION 35.2	167 lbs STANDARD_DEVIATION 37.1	170 lbs STANDARD_DEVIATION 33.6

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 56	0 / 53
other Total, other adverse events	0 / 56	0 / 53
serious Total, serious adverse events	0 / 56	0 / 53

Outcome results

Primary

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

Time frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

Population: Number analyzed for each timepoint is reflected below. Note some participants were lost to follow-up at each timepoint.

Arm	Measure	Group	Value (MEAN)	Dispersion
MOVE!	Change in Binge Episodes From Eating Disorder Examination Interview	Baseline	21.23 Number of binges	Standard Deviation 19.03
MOVE!	Change in Binge Episodes From Eating Disorder Examination Interview	3 Months	7.02 Number of binges	Standard Deviation 8.62
MOVE!	Change in Binge Episodes From Eating Disorder Examination Interview	9 Months	6.02 Number of binges	Standard Deviation 7.3
MOVE!	Change in Binge Episodes From Eating Disorder Examination Interview	15 Months	8.15 Number of binges	Standard Deviation 10.77
MOVE!+CBT	Change in Binge Episodes From Eating Disorder Examination Interview	15 Months	6.98 Number of binges	Standard Deviation 9.52
MOVE!+CBT	Change in Binge Episodes From Eating Disorder Examination Interview	Baseline	21.75 Number of binges	Standard Deviation 18.42
MOVE!+CBT	Change in Binge Episodes From Eating Disorder Examination Interview	9 Months	5.38 Number of binges	Standard Deviation 9.44
MOVE!+CBT	Change in Binge Episodes From Eating Disorder Examination Interview	3 Months	3.64 Number of binges	Standard Deviation 6.09

Primary

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

Time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment

Population: Number analyzed for each timepoint is reflected below. Note some participants were lost to follow-up at each timepoint.

Arm	Measure	Group	Value (MEAN)	Dispersion
MOVE!	Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)	Baseline	3.18 score on a scale	Standard Error 0.16
MOVE!	Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)	3 Months	2.81 score on a scale	Standard Error 0.17
MOVE!	Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)	9 Months	2.57 score on a scale	Standard Error 0.16
MOVE!	Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)	15 Months	2.50 score on a scale	Standard Error 0.16
MOVE!+CBT	Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)	15 Months	1.77 score on a scale	Standard Error 0.19
MOVE!+CBT	Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)	Baseline	2.89 score on a scale	Standard Error 0.19
MOVE!+CBT	Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)	9 Months	2.00 score on a scale	Standard Error 0.19
MOVE!+CBT	Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)	3 Months	2.13 score on a scale	Standard Error 0.17

Secondary

CBT Session Attendance (Treatment Dose)

CBT session attendance will be determined by the number of clinician-led individual sessions attended throughout the treatment.

Time frame: 3 month post-treatment

Arm	Measure	Value (MEAN)
MOVE!	CBT Session Attendance (Treatment Dose)	7.75 number of sessions

Secondary

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

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

Time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment