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Weight Loss Treatment for Veterans With Binge Eating

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ClinicalTrials.gov Identifier: NCT03234881
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

Inclusion Criteria: aged 21 and older, BMI>=25, and 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, and; pregnancy or lactation.

Participants will be recruited from the VA's MOVE! Program at VA Connecticut Healthcare System (both Newington and West Haven campuses). Those participants who meet eligibility and are interested in the study will meet with a research associate who will obtain written consent. A baseline appointment will be made where the participant will complete written assessments, anthropometric measures (weight, height, blood pressure etc.), along with a blood draw. Participants will then be randomized, by luck of a draw, to either MOVE! or MOVE!+gshCBT treatment.

For those randomized to the MOVE! condition, participants will continue in the MOVE! program by meeting with the multidisciplinary team in a group setting once a week for 60 minutes, for 16 weeks. The group sessions are lead by a dietician, health psychologist, and physical therapist.

For those randomized to the MOVE!+gshCBT treatments, participants will continue in the MOVE! program as described above, but will also partake in 8 individualized sessions over a 3-month period. Participants will be given a treatment manual to read at home, ask to complete daily food logs and work with the study therapist to create goals and complete homework that is geared at examining and changing how participant think about binge eating and how that thinking affects behavior. Lastly, a walking program will also be incorporated into the treatment.

For both treatment arms, 3 months from treatment starting, then again at 9 months and 15 months, participants will be asked to complete post and follow up assessments, much like the baseline.


Condition or disease Intervention/treatment Phase
Binge Eating Disorder Behavioral: MOVE! Behavioral: MOVE!+gshCBT Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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 (guided self-help Cognitive Behavioral Therapy).
Masking: Single (Care Provider)
Masking Description: Treating therapists will be blind to outcome data
Primary Purpose: Treatment
Official Title: Weight Loss Treatment and CBT for Veterans With Binge Eating
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : August 2, 2020
Estimated Study Completion Date : August 2, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MOVE!
Weight management delivered as Treatment-as-Usual
Behavioral: MOVE!
Participants randomized to the MOVE! arm will attend 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.

Experimental: MOVE!+gshCBT
Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
Behavioral: MOVE!+gshCBT
Participants randomized to the MOVE!+gshCBT arm will attend the 16 weeks of 60-minute weekly MOVE! Treatment groups, along with 8 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 partake in a walking program to gradually increase daily physical activity.




Primary Outcome Measures :
  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 trials61and has adequate convergence with the interview format62,63. 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.


Secondary Outcome Measures :
  1. Change in Beck Depression Inventory (BDI) [ Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment ]
    The BDI is a 21-item version, is a self-report measure for the symptoms of depression.

  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)

  3. Alcohol Use Disorders Identification Test (AUDIT-C) [ Time Frame: Change in Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment ]
    The AUDIT is a 3-item version, is a questionnaire that assesses for hazardous or harmful alcohol consumption.

  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.


Other Outcome Measures:
  1. Total number sessions of MOVE! group session attendance [ Time Frame: 3 month post treatment, 9 month post treatment, 15 month post treatment ]
    MOVE! group session attendance will be determined by the number of MOVE! group sessions attended throughout the treatment and follow-up phases.

  2. 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 weight in kilograms over height squared in centimeters. Weight will be measured by trained personnel using procedures based on the NHANES Anthropometry Procedures Manual70. Weight will be obtained using a high capacity digital platform scale that is regularly calibrated. Data will be obtained without shoes or coats. Height will be measured in duplicate using a wall-mounted stadiometer at baseline only. Weight data will additionally be collected weekly during treatment.

  3. Drug Abuse Screening [ Time Frame: Pre treatment ]
    Drug abuse will only be assessed at pre treatment because those meeting DSM-5 diagnostic criteria will be excluded from the study. The Mini-international Neuropsychiatric Interview (MINI) will be used.

  4. 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

  5. Change in Food Frequency Questionnaire (FFQ) [ Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment ]
    FFQ is a brief dietary screening tool that measures intakes of fruits and vegetables, percentage energy from fat, and fiber. Several validation studies have revealed good correlations with full food frequency measures and 24-hour dietary recalls.

  6. 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.

  7. Change in Six-Minute Walk Test (6MWT) [ Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment ]
    The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The test is used to detect changes following interventions to improve physical activity, and has been used with a wide range of populations including healthy and patient samples of children, adults and seniors. Overall, good reliability and validity have been reported for this measure although there is some variability depending upon patient sample used76. Among Veterans the measure has demonstrated good discriminant validity, and has detected changes following weight loss intervention.

  8. Treatment satisfaction [ Time Frame: 3 months post treatment ]
    Treatment satisfaction will be measured with both open-ended questions (e.g., "What aspects of the intervention do you find most helpful? What aspects of the intervention do you find least helpful? What suggestions do you have to improve the program?") and closed-ended questions (e.g., "On a scale of 0 to 10, how would you rate your overall satisfaction with the intervention you received?" Responses range from 0=Completely Dissatisfied to 10=Completely Satisfied).

  9. Change in HbA1c [ Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment ]
    Blood samples will be collected, after overnight fasting (12 hours), and analyzed for HbA1c.

  10. Change in Lipid Profile Analysis (Cholesterol) [ Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment ]

    Blood samples will be collected, after overnight fasting (12 hours), and analyzed for Lipid Profile Analysis (total cholesterol, high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), and triglycerides).

    Total cholesterol, HDL, LDL and triglycerides are measured by cholesterol levels in milligrams (mg) of cholesterol per deciliter (dL).


  11. Change in Blood Pressure (BP) [ Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment ]
    Systolic and diastolic will be measured with a digital wrist blood pressure monitor and the average of three measurements, at each assessment point, will be used.

  12. Change in Waist Circumference [ Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment ]
    Waist Circumference will be measured in inches, and will be assessed with a measuring tape placed horizontally just above the iliac crest, after completion of a respiratory cycle.

  13. Diabetes Status (covariate) [ Time Frame: Pre treatment ]
    Status determined by a diabetes diagnosis in the electronic health record.

  14. Change in Heart Rate (HR) [ Time Frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment ]
    Heart rate will be taken with a digital wrist blood pressure monitor and the average of three measurements, at each assessment point. Heart rate is measured in beats per minute.

  15. Statin Use (covariate) [ Time Frame: Pre treatment ]
    Use determined by statin prescription in the electronic health record.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234881


Contacts
Contact: Robin M Masheb, PhD (203) 932-5711 ext 3954 robin.masheb@va.gov

Locations
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Recruiting
West Haven, Connecticut, United States, 06516
Contact: Amanda M Kutz, PhD    (203) 932-5711    amanda.kutz@va.gov   
Principal Investigator: Robin Meryl Masheb, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Robin Meryl Masheb, PhD VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03234881     History of Changes
Other Study ID Numbers: IIR 15-349
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Recurrent Binge Eating
Cognitive Behavioral Therapist
Weight reduction

Additional relevant MeSH terms:
Weight Loss
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia
Body Weight Changes
Body Weight
Signs and Symptoms
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive