<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03234881</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 15-349</org_study_id>
    <nct_id>NCT03234881</nct_id>
  </id_info>
  <brief_title>Weight Loss Treatment for Veterans With Binge Eating</brief_title>
  <official_title>Weight Loss Treatment and CBT for Veterans With Binge Eating</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inclusion Criteria: aged 21 and older, BMI&gt;=25, and presence of recurrent binge eating on the&#xD;
      MOVE! Survey. Exclusion Criteria: more than 4 MOVE! sessions in the prior year; active&#xD;
      psychosis or suicidal ideation; medical or psychiatric illness, or cognitive deficits that&#xD;
      interfere with providing consent or completing assessments, and; pregnancy or lactation.&#xD;
&#xD;
      Participants will be recruited from the VA's MOVE! Program at VA Connecticut Healthcare&#xD;
      System (both Newington and West Haven campuses). Those participants who meet eligibility and&#xD;
      are interested in the study will meet with a research associate who will obtain written&#xD;
      consent. A baseline appointment will be made where the participant will complete written&#xD;
      assessments, anthropometric measures (weight, height, blood pressure etc.), along with a&#xD;
      blood draw. Participants will then be randomized, by luck of a draw, to either MOVE! or&#xD;
      MOVE!+clinician-led CBT treatment.&#xD;
&#xD;
      For those randomized to the MOVE! condition, participants will continue in the MOVE! program&#xD;
      by meeting with the multidisciplinary team in a group setting once a week for 60 minutes, for&#xD;
      16 weeks. The group sessions are lead by a dietician, health psychologist, and physical&#xD;
      therapist.&#xD;
&#xD;
      For those randomized to the MOVE!+CBT treatments, participants will continue in the MOVE!&#xD;
      program as described above, but will also partake in up to 10 individualized sessions over a&#xD;
      3-month period. Participants will be given a treatment manual to read at home, ask to&#xD;
      complete daily food logs and work with the study therapist to create goals and complete&#xD;
      homework that is geared at examining and changing how participant think about binge eating&#xD;
      and how that thinking affects behavior. Lastly, a walking program will also be incorporated&#xD;
      into the treatment.&#xD;
&#xD;
      For both treatment arms, 3 months from treatment starting, then again at 9 months and 15&#xD;
      months, participants will be asked to complete post and follow up assessments, much like the&#xD;
      baseline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We are currently recruiting for Phase 3 of this study. Phase 3 of the study is be conducted&#xD;
      entirely virtually, leveraging the VA's national TeleMOVE program and Virtual MOVE groups and&#xD;
      the study arms will now be TeleMOVE/Virtual MOVE only (control) or TeleMOVE/Virtual MOVE +&#xD;
      CBT (treatment). As such, this project modification required several changes and additions to&#xD;
      the protocol, to ease administrative burden we have added a Phase 3 to this trial to&#xD;
      accommodate all the necessary waiver, consent, and procedural changes necessary to enact this&#xD;
      project. The following are included in this modification for Phase 3: Waivers: Add WIC, WWIC,&#xD;
      WOA. Consent/Recruitment: Add Study Information Sheets and Opt-out Letters for potential&#xD;
      participants, phone screen and chart review. Study Site: Add VA Central Western MA in&#xD;
      addition to VACHS.&#xD;
&#xD;
      RESEARCH DESIGN AND METHODS&#xD;
&#xD;
      Design Overview To address the specific aims of this proposal, the investigators will conduct&#xD;
      an RCT comparing MOVE! (treatment-as-usual; MOVE!) to MOVE! plus CBT (MOVE! + CBT).&#xD;
      Overweight/obese Veterans (109 men and women) with recurrent binge eating as reported on the&#xD;
      binge eating item from the MOVE! survey will be enrolled. Potential participants will be&#xD;
      recruited from MOVE! group orientation meetings at two VA CT sites which take place several&#xD;
      times per month. Major assessments will be performed by an independent evaluator at&#xD;
      pre-treatment (baseline), at the end of CBT treatment (3 months), and at 6- and 12-months&#xD;
      following treatments (9 and 15 months after randomization). Analyses are powered for the&#xD;
      primary outcome of binge remission (categorical). Analyses for binge frequency (continuous),&#xD;
      and eating disorder and mental health outcomes will be performed. Exploratory analyses will&#xD;
      be conducted on treatment engagement (MOVE! session attendance) and weight outcomes (weight&#xD;
      loss and metabolic outcomes), as well as for potential predictors and moderators (age,&#xD;
      gender, clinical severity, and comorbidity), and correlates (change in weight control&#xD;
      strategies and physical activity) of treatment outcome.&#xD;
&#xD;
      Participants Criteria have been kept to a minimum to increase the generalizability of&#xD;
      findings. Inclusion Criteria: aged 21 and older, BMI&gt;=25, and presence of recurrent binge&#xD;
      eating on the MOVE! Survey. Exclusion Criteria: more than 4 MOVE! sessions in the prior year;&#xD;
      active psychosis or suicidal ideation; medical or psychiatric illness, or cognitive deficits&#xD;
      that interfere with providing consent or completing assessments, and; pregnancy or lactation.&#xD;
      The investigators will aim for a sample that is 34% racial/ethnic minority (66% Caucasian) to&#xD;
      be consistent with the demographics of a nationally representative sample of Veterans seeking&#xD;
      weight management treatment through VHA3. The investigators will also aim for 25% women (75%&#xD;
      men), a figure that represents an oversampling of women compared to the rate of 6% for all&#xD;
      VHA users. This will allow us to examine gender as a potential predictor or moderator of&#xD;
      treatment outcome and address the VHA's strategic plan to better serve women Veterans.&#xD;
&#xD;
      Recruitment Potential participants will be recruited from orientation sessions for MOVE!&#xD;
      groups conducted at two sites, the West Haven and Newington campuses, of VA CT. While MOVE!&#xD;
      is delivered in different formats (i.e., group, individual and telehealth), the group format&#xD;
      accounts for 75% of weight management services delivered across the VHA. The Research&#xD;
      Assistant will be given a few minutes at the beginning of each orientation session to&#xD;
      describe the study. Orientation sessions are available to Veterans three times per month&#xD;
      between the two sites. Names and numbers will be collected of those who are interested so&#xD;
      that they may be contacted for individual sessions to assess interest and eligibility using&#xD;
      the criteria above. Dr. Ruser (Co-I, Chief of Primary Care and MOVE! Physician Champion for&#xD;
      VA CT) oversees the program at both campuses, and Dr. Dorflinger (Co-I, Health Behavioral&#xD;
      Coordinator who is directly responsible for the delivery of MOVE!) splits her time between&#xD;
      the two sites. According to MOVE! performance measures, a greater number of patients are seen&#xD;
      for weight management at the Newington campus compared to the West Haven campus. The&#xD;
      investigators plan to test, and control, for potential site differences in the analyses. In&#xD;
      addition, Dr. Driscoll (Co-I), women Veteran's health researcher for the VHA's Women's&#xD;
      Practice Based Research Network, and clinical supervisor for the local women's clinic, will&#xD;
      be responsible for recruiting women Veterans into the MOVE! orientation sessions and&#xD;
      treatment study. She has experience successfully oversampling for women Veterans in a&#xD;
      previous trial that resulted in 25% women (compared to 6% of all VHA users)38.&#xD;
&#xD;
      Screening for &quot;recurrent binge eating&quot; The presence of binge eating will be determined by the&#xD;
      MOVE! Survey, an 11-item self-report survey that must be completed prior to attending MOVE!&#xD;
      programs. This survey was created to aid in the tailoring of MOVE! treatment for patients'&#xD;
      specific needs. The item that assesses the presence of binge eating reads as follows: &quot;On&#xD;
      average, how often have you eaten extremely large amounts of food at one time and felt that&#xD;
      your eating was out of control at that time?&quot; The response set for this item is never, less&#xD;
      than one time per week, one time per week, two to four times per week, or five or more times&#xD;
      per week. Participants reporting binge eating at least one time per week will be included&#xD;
      following published methods. These methods come from two effectiveness studies for recurrent&#xD;
      binge eating that have been conducted with participants from a large integrated healthcare&#xD;
      system18,19. Further assessment with the Eating Disorder Examination-Interview 12th Ed.&#xD;
      (EDE)46, described below, will enable us to further categorize participants who meet full&#xD;
      DSM-5 diagnostic criteria for BED (clinical BED) and those who do not (subclinical BED).&#xD;
&#xD;
      Informed consent and pre-treatment assessment If the potential participant is eligible and&#xD;
      interested, a pre-treatment assessment of one to two sessions will be scheduled. This&#xD;
      assessment will help to determine whether participants are able to comply with the&#xD;
      requirements of the program (such as regular appointments and record-keeping) and also to&#xD;
      minimize the attrition rate of the trial, since only those who complete these requirements&#xD;
      will be enrolled. The Research Assistant will describe the study, and the consent will be&#xD;
      reviewed verbally and in writing, before IRB written informed consent is obtained. During the&#xD;
      pre-treatment assessment session(s), the following will be obtained/completed: anthropometric&#xD;
      measures (height, weight, waist circumference, blood pressure; methods described below),&#xD;
      demographic information (age, gender, race/ethnicity, etc.), self-report measures (described&#xD;
      below), blood draw, psychiatric evaluation with the Mini-Neuropsychiatric Interview (MINI)49,&#xD;
      and the eating disorder evaluation with the Eating Disorder Examination-Interview 12th Ed.&#xD;
      (EDE)46.&#xD;
&#xD;
      Determination of binge status: Subclinical vs. Clinical BED The Eating Disorder&#xD;
      Examination-Interview 12th Edition (EDE)46 is the structured diagnostic interview that is&#xD;
      considered the gold-standard to diagnose, and assess the symptoms of, eating disorders&#xD;
      including binge eating and eating disorder pathology. The EDE will be used to categorize&#xD;
      participants as clinical BED (meeting full DSM-5 criteria including a binge frequency of at&#xD;
      least one time per week on average for the past three months) or subclinical BED (reporting&#xD;
      at least one time per week binge eating on the MOVE! survey but not meeting DSM-5 criteria&#xD;
      for BED). The Research Assistant will be trained and supervised by Dr. Masheb (PI) who has&#xD;
      extensive experience with the EDE. Binge status will be used as a potential covariate in&#xD;
      analyses.&#xD;
&#xD;
      Randomization procedures Eligible patients who agree to participate and sign consent forms&#xD;
      will be randomly assigned to MOVE! or MOVE!+CBT in the order in which they complete the&#xD;
      evaluation process. Equal numbers of participants will be randomly assigned to each of the&#xD;
      two conditions. The randomization schedule will be created with a random number generator,&#xD;
      independent of the investigators.&#xD;
&#xD;
      Control condition: MOVE! (treatment-as-usual) Based on scientific review and practice&#xD;
      guidelines of the NIH, and in collaboration with VHA Central Office, the MOVE! program was&#xD;
      developed as an evidence-based weight management and physical activity initiative that&#xD;
      included assessment and treatment procedures, clinical algorithms, patient and provider&#xD;
      information, and instructional materials. The program was widely disseminated and implemented&#xD;
      beginning in January 200653. Every VHA facility across the country is required to have some&#xD;
      form of the MOVE! program, if not several programs differing in intensity, which utilize&#xD;
      these materials. At a minimum, on-site weekly, multidisciplinary groups must be held. MOVE!&#xD;
      group at VA CT is the most widely used weight management service and was thus chosen as the&#xD;
      treatment-as-usual for the present study given the potential for disseminability. Research&#xD;
      has demonstrated minimal weight losses with MOVE! and these findings have largely been&#xD;
      attributed to poor treatment engagement (i.e., attendance) and weight gain in the year prior&#xD;
      to treatment initiation54,55. One initiative to increase the reach and impact of weight&#xD;
      management in the Veteran population has been to identify vulnerable subgroups of&#xD;
      overweight/obese patients, such as those with binge eating8, pain56, and serious mental&#xD;
      illness57. The hope is that the present study will extend this initiative.&#xD;
&#xD;
      All participants will receive MOVE! group treatment as it is delivered at VA CT or VA Central&#xD;
      Western MA. The 60-minute groups cycle every 16 weeks and are led by a physical therapist,&#xD;
      dietitian, and/or clinical health psychology predoctoral intern. Clinicians utilize materials&#xD;
      available on-line, and encourage the use of, but do not require or provide, food diaries.&#xD;
      Participants in both MOVE! and MOVE!+CBT will be encouraged to attend these sessions&#xD;
      throughout their involvement in the entire study (i.e., during treatment and follow-up&#xD;
      phases). MOVE! is similarly delivered at both the VA CT West Haven and Newington facilities&#xD;
      as both programs are overseen by Drs. Ruser and Dorflinger (Co-Is).&#xD;
&#xD;
      Experimental condition: MOVE!+CBT One-half of participants will be randomly assigned to&#xD;
      MOVE!+CBT and will receive the MOVE! treatment described above as well as a CBT treatment for&#xD;
      binge eating. CBT will be administered via 9 individual clinician-led sessions over a 3-month&#xD;
      treatment period. The first two sessions will be 60 minutes each and subsequent sessions will&#xD;
      be 30 minutes. CBT has emerged as the treatment of choice for BED for its robust effects on&#xD;
      reducing binge eating and improving the behavioral and psychological aspects of the&#xD;
      disorder9. The CBT treatment will adhere to a manual developed by Dr. Masheb (PI) and&#xD;
      generally follows the book Overcoming Binge Eating 58 that has been used by Drs. Masheb and&#xD;
      Grilo (Co-I) in previous published studies of CBT11,21,32-35, as well as by others 12,40,59.&#xD;
&#xD;
      Participants will be given the CBT manual with a schedule to read at home. During sessions,&#xD;
      the Psychologist will use the following session guideline: 1) setting an agenda, 2) reviewing&#xD;
      food diaries and self-monitoring, 3) introduction of new material from the manual, 4)&#xD;
      reviewing old material and problem-solving difficulties, and 5) establishing new homework and&#xD;
      goals. The treatment follows three stages. Stage 1 consists of presentation of the CBT model;&#xD;
      introduction and discussion of the structure, goals, interventions, and expected outcome of&#xD;
      treatment; education regarding binge eating and dieting; and the introduction of&#xD;
      self-monitoring techniques for identifying problematic eating practices and triggers. Stage 2&#xD;
      consists of maintaining the normalized eating and self-monitoring procedures but becomes&#xD;
      increasingly cognitively oriented. Stage 3 focuses on practicing skills, consolidation of&#xD;
      progress and relapse prevention.&#xD;
&#xD;
      At each session participants will receive new, blank food diaries. Participants are expected&#xD;
      to complete these diaries on a daily basis, and they will be reviewed and checked at each&#xD;
      session by the Psychologist. If participants would like to use these food diaries for their&#xD;
      MOVE! treatment as well, they may do so. [NOTE: Food diaries are encouraged in MOVE! but are&#xD;
      not provided or required.] CBT participants will also be instructed in how to record (i.e.,&#xD;
      self-monitor) binge eating. Recording of this data will be mandatory and participants who&#xD;
      arrive to session with incomplete food diaries or self-monitoring will be asked to use&#xD;
      session time to complete these records for at least the previous day or two. This technique&#xD;
      emphasizes the importance of food diaries, raises patients' awareness of their eating, allows&#xD;
      clinicians to address any concerns about how to complete diaries, and demonstrates that&#xD;
      diaries can be completed without too much effort. The investigators will continue this&#xD;
      strategy through all CBT sessions until the patients arrive to sessions with diaries&#xD;
      completed. This typically takes two sessions, however sometimes food diary non-compliance can&#xD;
      reemerge later in treatment. In this scenario in-session diary completion is reintroduced&#xD;
      following the same procedure. Patients will also be encouraged to gradually increase daily&#xD;
      modest physical activity with the goal of establishing 30 minutes of activity (walking&#xD;
      sessions or other activity) five times per week. This prescription is consistent with&#xD;
      recommendations from several expert-based organizations (NIH and Centers for Disease&#xD;
      Control).&#xD;
&#xD;
      Measurements Participant assessments will be conducted by the Research Assistant and&#xD;
      independent of the treating Psychologist so that assessment will be unbiased. These will&#xD;
      include outcomes for: binge eating and mental health; engagement and weight; weight control&#xD;
      behaviors and physical activity, and; treatment satisfaction and adherence.&#xD;
&#xD;
      Statistical considerations&#xD;
&#xD;
      Analytic Plan. Statistical analyses will be conducted by a biostatistician and who has&#xD;
      extensive experience in statistical modeling, particularly in the analysis of longitudinal&#xD;
      data. Baseline characteristics will be compared between the treatment groups using ANOVA and&#xD;
      chi-squares as appropriate in order to determine the level of success of the randomization.&#xD;
      Distributions of outcomes will be examined in order to determine if assumptions of specific&#xD;
      model types are met. Change of model type as well as transformation of the data will be&#xD;
      considered if model assumptions are not met. Mixed-effects models, a method for statistical&#xD;
      modeling that uses both fixed effects and random effects, will be used to examine continuous&#xD;
      outcomes such as binge eating frequency, mental health symptoms, and percent weight loss for&#xD;
      completer, as well as intent-to-treat (all randomized persons), analyses. Logistic regression&#xD;
      models will be used for categorical outcomes such as binge remission and achieving clinically&#xD;
      meaningful weight loss (i.e., 5% weight loss or greater). Missing data and covariate&#xD;
      adjustment will be handled.&#xD;
&#xD;
      Aim 1 addresses binge eating (primary outcome) and mental health outcomes. Binge remission&#xD;
      (H1; defined as zero binges for the 28 days prior to the end of treatment) will be examined&#xD;
      as a binary outcome in logistic models including treatment group and relevant covariates.&#xD;
      Reduction in frequency of binge eating over time will be examined using mixed effects models.&#xD;
      Previous work indicates that the outcomes may need to be log-transformed to better&#xD;
      approximate normality11. Mental health outcomes (H2), using validated symptom scales for&#xD;
      depression and quality-of-life, will also be examined using mixed models. Relevant&#xD;
      demographic and clinical characteristics will be included in the logistic and mixed models,&#xD;
      and main as well as interaction effects will be investigated.&#xD;
&#xD;
      Aim 2 addresses level of engagement in weight loss treatment (i.e., number of MOVE! treatment&#xD;
      sessions) and weight outcome. Engagement (H1) will be explored using Poisson regression on&#xD;
      counts of MOVE! sessions completed using a binary treatment variable (MOVE! vs. MOVE!+CBT).&#xD;
      The distribution of engagement will be reviewed to determine if there is over-dispersion (in&#xD;
      which case quasi-likelihood estimation will be used to account for it). Models will include&#xD;
      relevant covariates such as demographic and clinical characteristics. The treatment effect on&#xD;
      weight (H2) will be examined with a mixed effects model, as described above, using&#xD;
      longitudinal change in percent weight loss during the intervention and follow-up phases.&#xD;
      Categorical analyses will also be performed comparing treatments on the proportion of&#xD;
      participants achieving 5% weight losses using logistic regression analysis.&#xD;
&#xD;
      Exploratory analyses will be performed on the metabolic outcomes (HbA1C, total cholesterol,&#xD;
      HDL, LDL, triglycerides, systolic and diastolic blood pressure, and waist circumference)&#xD;
      using mixed models. These outcomes were chosen for analysis to be consistent with interests&#xD;
      of health services research although the investigators recognize that changes in these&#xD;
      measures may not be sufficient to detect a difference. These analyses also could be important&#xD;
      downstream in adding credibility in the eyes of patients, and providers, and could be used to&#xD;
      enhance incentives for participation (or patient referral).&#xD;
&#xD;
      Aim 3 is an examination of predictors, moderators and correlates of treatment outcome.&#xD;
      Predictors are variables present at baseline that influence outcome regardless of treatment&#xD;
      condition, and moderators are variables present at baseline that influence outcome depending&#xD;
      on the treatment condition. Potential predictors and moderators (H1) will be explored with&#xD;
      demographic (age and gender)81, and clinical characteristics (clinical severity and&#xD;
      comorbidity) from the relevant literature on BED82,83. Logistic and multiple regression&#xD;
      analyses, that have been detailed conceptually and analytically by Kraemer et al.84, will be&#xD;
      used. Associations (H2) between changes in weight control strategies and physical activity,&#xD;
      and weight loss 71 will be examined with correlation analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Actual">May 23, 2023</completion_date>
  <primary_completion_date type="Actual">May 23, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>Treating therapists will be blind to outcome data</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)</measure>
    <time_frame>Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Binge Episodes from Eating Disorder Examination Interview</measure>
    <time_frame>Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>The EDE is a clinician administered interview that is considered to be the gold standard for diagnosing eating disorders and assessing binge frequency.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>The PHQ-9 is a 9-item version, is a self-report measure for the symptoms of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PTSD Checklist (PCL-5)</measure>
    <time_frame>Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of Post Traumatic Stress Disorder (PTSD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight and Eating Quality of Life (WE-QoL)</measure>
    <time_frame>Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>The WE-QoL is an 8-item self-report instrument for measurement of the impact weight and eating has on quality-of-life outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in European Quality of Life (EuroQoL-5D)</measure>
    <time_frame>Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Night Eating Questionnaire (NEQ)</measure>
    <time_frame>Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>The NEQ is a 14-item self-report instrument for the measurement of Night Eating Syndrome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3 month post treatment</measure>
    <time_frame>Total number sessions of CBT session attendance</time_frame>
    <description>CBT session attendance will be determined by the number of clinician-led individual sessions attended throughout the treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Total number sessions of MOVE! group (or TeleMOVE!) session attendance</measure>
    <time_frame>3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>MOVE! group session attendance will be determined by the number of MOVE! group sessions attended throughout the treatment and follow-up phases.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in BMI</measure>
    <time_frame>Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>BMI will be calculated based upon self-reported height and weight.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Weight Control Strategies Scale (WCSS)</measure>
    <time_frame>Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in 24 Hour Food Frequency Questionnaire (24 Hour-FFQ)</measure>
    <time_frame>Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>FFQ is a brief dietary screening tool that measures intake of foods related to weight gain and loss.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Godin Leisure Time Exercise Questionnaire (Godin)</measure>
    <time_frame>Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment satisfaction</measure>
    <time_frame>3 months post treatment</time_frame>
    <description>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., &quot;I increased my ability to manage my binge eating&quot; and &quot;How likely are you to recommend this treatment to other Veterans?&quot;).</description>
  </other_outcome>
  <other_outcome>
    <measure>Impact of COVID-19</measure>
    <time_frame>Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>Brief 15-item questionnaire of the impact COVID-19 has had on patients currently participating in our research study. This survey will provide critical context to other data we are collecting about potential changes in participants eating behaviors over the course of our trial.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in weight</measure>
    <time_frame>Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>All weights will be pulled from the electronic health record within two years before date of randomization.</description>
  </other_outcome>
  <other_outcome>
    <measure>Diabetes Status (covariate)</measure>
    <time_frame>Pre treatment</time_frame>
    <description>Status determined by a diabetes diagnosis in the electronic health record.</description>
  </other_outcome>
  <other_outcome>
    <measure>Loss of Control Overeating Scale (LOCES)</measure>
    <time_frame>Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>A self-administered scale used to assess features of loss of control over eating.</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)</measure>
    <time_frame>Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment</time_frame>
    <description>A self-administered scale used to assess the features of food addiction. Scores range from 0-28 with higher scores reflecting worse outcome.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Binge Eating Disorder</condition>
  <arm_group>
    <arm_group_label>MOVE!</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Weight management delivered as Treatment-as-Usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MOVE!+CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MOVE!</intervention_name>
    <description>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.</description>
    <arm_group_label>MOVE!</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MOVE!+CBT</intervention_name>
    <description>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.</description>
    <arm_group_label>MOVE!+CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI&gt;=25&#xD;
&#xD;
          -  Presence of recurrent binge eating on the MOVE! Survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than 4 MOVE! sessions in the prior year&#xD;
&#xD;
          -  Active psychosis or suicidal ideation&#xD;
&#xD;
          -  Medical or psychiatric illness, or cognitive deficits that interfere with providing&#xD;
             consent or completing assessments&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin Meryl Masheb, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Connecticut Healthcare System West Haven Campus, West Haven, CT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Connecticut Healthcare System West Haven Campus, West Haven, CT</name>
      <address>
        <city>West Haven</city>
        <state>Connecticut</state>
        <zip>06516-2770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Central Western Massachusetts Healthcare System, Leeds, MA</name>
      <address>
        <city>Leeds</city>
        <state>Massachusetts</state>
        <zip>01053-9764</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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>
    <PMID>28271431</PMID>
  </reference>
  <results_reference>
    <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>
    <PMID>32107681</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>36973571</PMID>
  </results_reference>
  <results_reference>
    <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 May 18:1-15. doi: 10.1080/00952990.2023.2207720. Online ahead of print.</citation>
    <PMID>37200510</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Binge Eating</keyword>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>Weight Management</keyword>
  <keyword>Veterans</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
    <mesh_term>Binge-Eating Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Unable to share Veteran data</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03234881
org study id: IIR 15-349
nct id: NCT03234881
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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!+clinician-led CBT 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!+CBT treatments, participants will continue in the MOVE!
      program as described above, but will also partake in up to 10 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.
We are currently recruiting for Phase 3 of this study. Phase 3 of the study is be conducted
      entirely virtually, leveraging the VA's national TeleMOVE program and Virtual MOVE groups and
      the study arms will now be TeleMOVE/Virtual MOVE only (control) or TeleMOVE/Virtual MOVE +
      CBT (treatment). As such, this project modification required several changes and additions to
      the protocol, to ease administrative burden we have added a Phase 3 to this trial to
      accommodate all the necessary waiver, consent, and procedural changes necessary to enact this
      project. The following are included in this modification for Phase 3: Waivers: Add WIC, WWIC,
      WOA. Consent/Recruitment: Add Study Information Sheets and Opt-out Letters for potential
      participants, phone screen and chart review. Study Site: Add VA Central Western MA in
      addition to VACHS.

      RESEARCH DESIGN AND METHODS

      Design Overview To address the specific aims of this proposal, the investigators will conduct
      an RCT comparing MOVE! (treatment-as-usual; MOVE!) to MOVE! plus CBT (MOVE! + CBT).
      Overweight/obese Veterans (109 men and women) with recurrent binge eating as reported on the
      binge eating item from the MOVE! survey will be enrolled. Potential participants will be
      recruited from MOVE! group orientation meetings at two VA CT sites which take place several
      times per month. Major assessments will be performed by an independent evaluator at
      pre-treatment (baseline), at the end of CBT treatment (3 months), and at 6- and 12-months
      following treatments (9 and 15 months after randomization). Analyses are powered for the
      primary outcome of binge remission (categorical). Analyses for binge frequency (continuous),
      and eating disorder and mental health outcomes will be performed. Exploratory analyses will
      be conducted on treatment engagement (MOVE! session attendance) and weight outcomes (weight
      loss and metabolic outcomes), as well as for potential predictors and moderators (age,
      gender, clinical severity, and comorbidity), and correlates (change in weight control
      strategies and physical activity) of treatment outcome.

      Participants Criteria have been kept to a minimum to increase the generalizability of
      findings. 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.
      The investigators will aim for a sample that is 34% racial/ethnic minority (66% Caucasian) to
      be consistent with the demographics of a nationally representative sample of Veterans seeking
      weight management treatment through VHA3. The investigators will also aim for 25% women (75%
      men), a figure that represents an oversampling of women compared to the rate of 6% for all
      VHA users. This will allow us to examine gender as a potential predictor or moderator of
      treatment outcome and address the VHA's strategic plan to better serve women Veterans.

      Recruitment Potential participants will be recruited from orientation sessions for MOVE!
      groups conducted at two sites, the West Haven and Newington campuses, of VA CT. While MOVE!
      is delivered in different formats (i.e., group, individual and telehealth), the group format
      accounts for 75% of weight management services delivered across the VHA. The Research
      Assistant will be given a few minutes at the beginning of each orientation session to
      describe the study. Orientation sessions are available to Veterans three times per month
      between the two sites. Names and numbers will be collected of those who are interested so
      that they may be contacted for individual sessions to assess interest and eligibility using
      the criteria above. Dr. Ruser (Co-I, Chief of Primary Care and MOVE! Physician Champion for
      VA CT) oversees the program at both campuses, and Dr. Dorflinger (Co-I, Health Behavioral
      Coordinator who is directly responsible for the delivery of MOVE!) splits her time between
      the two sites. According to MOVE! performance measures, a greater number of patients are seen
      for weight management at the Newington campus compared to the West Haven campus. The
      investigators plan to test, and control, for potential site differences in the analyses. In
      addition, Dr. Driscoll (Co-I), women Veteran's health researcher for the VHA's Women's
      Practice Based Research Network, and clinical supervisor for the local women's clinic, will
      be responsible for recruiting women Veterans into the MOVE! orientation sessions and
      treatment study. She has experience successfully oversampling for women Veterans in a
      previous trial that resulted in 25% women (compared to 6% of all VHA users)38.

      Screening for "recurrent binge eating" The presence of binge eating will be determined by the
      MOVE! Survey, an 11-item self-report survey that must be completed prior to attending MOVE!
      programs. This survey was created to aid in the tailoring of MOVE! treatment for patients'
      specific needs. The item that assesses the presence of binge eating reads as follows: "On
      average, how often have you eaten extremely large amounts of food at one time and felt that
      your eating was out of control at that time?" The response set for this item is never, less
      than one time per week, one time per week, two to four times per week, or five or more times
      per week. Participants reporting binge eating at least one time per week will be included
      following published methods. These methods come from two effectiveness studies for recurrent
      binge eating that have been conducted with participants from a large integrated healthcare
      system18,19. Further assessment with the Eating Disorder Examination-Interview 12th Ed.
      (EDE)46, described below, will enable us to further categorize participants who meet full
      DSM-5 diagnostic criteria for BED (clinical BED) and those who do not (subclinical BED).

      Informed consent and pre-treatment assessment If the potential participant is eligible and
      interested, a pre-treatment assessment of one to two sessions will be scheduled. This
      assessment will help to determine whether participants are able to comply with the
      requirements of the program (such as regular appointments and record-keeping) and also to
      minimize the attrition rate of the trial, since only those who complete these requirements
      will be enrolled. The Research Assistant will describe the study, and the consent will be
      reviewed verbally and in writing, before IRB written informed consent is obtained. During the
      pre-treatment assessment session(s), the following will be obtained/completed: anthropometric
      measures (height, weight, waist circumference, blood pressure; methods described below),
      demographic information (age, gender, race/ethnicity, etc.), self-report measures (described
      below), blood draw, psychiatric evaluation with the Mini-Neuropsychiatric Interview (MINI)49,
      and the eating disorder evaluation with the Eating Disorder Examination-Interview 12th Ed.
      (EDE)46.

      Determination of binge status: Subclinical vs. Clinical BED The Eating Disorder
      Examination-Interview 12th Edition (EDE)46 is the structured diagnostic interview that is
      considered the gold-standard to diagnose, and assess the symptoms of, eating disorders
      including binge eating and eating disorder pathology. The EDE will be used to categorize
      participants as clinical BED (meeting full DSM-5 criteria including a binge frequency of at
      least one time per week on average for the past three months) or subclinical BED (reporting
      at least one time per week binge eating on the MOVE! survey but not meeting DSM-5 criteria
      for BED). The Research Assistant will be trained and supervised by Dr. Masheb (PI) who has
      extensive experience with the EDE. Binge status will be used as a potential covariate in
      analyses.

      Randomization procedures Eligible patients who agree to participate and sign consent forms
      will be randomly assigned to MOVE! or MOVE!+CBT in the order in which they complete the
      evaluation process. Equal numbers of participants will be randomly assigned to each of the
      two conditions. The randomization schedule will be created with a random number generator,
      independent of the investigators.

      Control condition: MOVE! (treatment-as-usual) Based on scientific review and practice
      guidelines of the NIH, and in collaboration with VHA Central Office, the MOVE! program was
      developed as an evidence-based weight management and physical activity initiative that
      included assessment and treatment procedures, clinical algorithms, patient and provider
      information, and instructional materials. The program was widely disseminated and implemented
      beginning in January 200653. Every VHA facility across the country is required to have some
      form of the MOVE! program, if not several programs differing in intensity, which utilize
      these materials. At a minimum, on-site weekly, multidisciplinary groups must be held. MOVE!
      group at VA CT is the most widely used weight management service and was thus chosen as the
      treatment-as-usual for the present study given the potential for disseminability. Research
      has demonstrated minimal weight losses with MOVE! and these findings have largely been
      attributed to poor treatment engagement (i.e., attendance) and weight gain in the year prior
      to treatment initiation54,55. One initiative to increase the reach and impact of weight
      management in the Veteran population has been to identify vulnerable subgroups of
      overweight/obese patients, such as those with binge eating8, pain56, and serious mental
      illness57. The hope is that the present study will extend this initiative.

      All participants will receive MOVE! group treatment as it is delivered at VA CT or VA Central
      Western MA. The 60-minute groups cycle every 16 weeks and are led by a physical therapist,
      dietitian, and/or clinical health psychology predoctoral intern. Clinicians utilize materials
      available on-line, and encourage the use of, but do not require or provide, food diaries.
      Participants in both MOVE! and MOVE!+CBT will be encouraged to attend these sessions
      throughout their involvement in the entire study (i.e., during treatment and follow-up
      phases). MOVE! is similarly delivered at both the VA CT West Haven and Newington facilities
      as both programs are overseen by Drs. Ruser and Dorflinger (Co-Is).

      Experimental condition: MOVE!+CBT One-half of participants will be randomly assigned to
      MOVE!+CBT and will receive the MOVE! treatment described above as well as a CBT treatment for
      binge eating. CBT will be administered via 9 individual clinician-led sessions over a 3-month
      treatment period. The first two sessions will be 60 minutes each and subsequent sessions will
      be 30 minutes. CBT has emerged as the treatment of choice for BED for its robust effects on
      reducing binge eating and improving the behavioral and psychological aspects of the
      disorder9. The CBT treatment will adhere to a manual developed by Dr. Masheb (PI) and
      generally follows the book Overcoming Binge Eating 58 that has been used by Drs. Masheb and
      Grilo (Co-I) in previous published studies of CBT11,21,32-35, as well as by others 12,40,59.

      Participants will be given the CBT manual with a schedule to read at home. During sessions,
      the Psychologist will use the following session guideline: 1) setting an agenda, 2) reviewing
      food diaries and self-monitoring, 3) introduction of new material from the manual, 4)
      reviewing old material and problem-solving difficulties, and 5) establishing new homework and
      goals. The treatment follows three stages. Stage 1 consists of presentation of the CBT model;
      introduction and discussion of the structure, goals, interventions, and expected outcome of
      treatment; education regarding binge eating and dieting; and the introduction of
      self-monitoring techniques for identifying problematic eating practices and triggers. Stage 2
      consists of maintaining the normalized eating and self-monitoring procedures but becomes
      increasingly cognitively oriented. Stage 3 focuses on practicing skills, consolidation of
      progress and relapse prevention.

      At each session participants will receive new, blank food diaries. Participants are expected
      to complete these diaries on a daily basis, and they will be reviewed and checked at each
      session by the Psychologist. If participants would like to use these food diaries for their
      MOVE! treatment as well, they may do so. [NOTE: Food diaries are encouraged in MOVE! but are
      not provided or required.] CBT participants will also be instructed in how to record (i.e.,
      self-monitor) binge eating. Recording of this data will be mandatory and participants who
      arrive to session with incomplete food diaries or self-monitoring will be asked to use
      session time to complete these records for at least the previous day or two. This technique
      emphasizes the importance of food diaries, raises patients' awareness of their eating, allows
      clinicians to address any concerns about how to complete diaries, and demonstrates that
      diaries can be completed without too much effort. The investigators will continue this
      strategy through all CBT sessions until the patients arrive to sessions with diaries
      completed. This typically takes two sessions, however sometimes food diary non-compliance can
      reemerge later in treatment. In this scenario in-session diary completion is reintroduced
      following the same procedure. Patients will also be encouraged to gradually increase daily
      modest physical activity with the goal of establishing 30 minutes of activity (walking
      sessions or other activity) five times per week. This prescription is consistent with
      recommendations from several expert-based organizations (NIH and Centers for Disease
      Control).

      Measurements Participant assessments will be conducted by the Research Assistant and
      independent of the treating Psychologist so that assessment will be unbiased. These will
      include outcomes for: binge eating and mental health; engagement and weight; weight control
      behaviors and physical activity, and; treatment satisfaction and adherence.

      Statistical considerations

      Analytic Plan. Statistical analyses will be conducted by a biostatistician and who has
      extensive experience in statistical modeling, particularly in the analysis of longitudinal
      data. Baseline characteristics will be compared between the treatment groups using ANOVA and
      chi-squares as appropriate in order to determine the level of success of the randomization.
      Distributions of outcomes will be examined in order to determine if assumptions of specific
      model types are met. Change of model type as well as transformation of the data will be
      considered if model assumptions are not met. Mixed-effects models, a method for statistical
      modeling that uses both fixed effects and random effects, will be used to examine continuous
      outcomes such as binge eating frequency, mental health symptoms, and percent weight loss for
      completer, as well as intent-to-treat (all randomized persons), analyses. Logistic regression
      models will be used for categorical outcomes such as binge remission and achieving clinically
      meaningful weight loss (i.e., 5% weight loss or greater). Missing data and covariate
      adjustment will be handled.

      Aim 1 addresses binge eating (primary outcome) and mental health outcomes. Binge remission
      (H1; defined as zero binges for the 28 days prior to the end of treatment) will be examined
      as a binary outcome in logistic models including treatment group and relevant covariates.
      Reduction in frequency of binge eating over time will be examined using mixed effects models.
      Previous work indicates that the outcomes may need to be log-transformed to better
      approximate normality11. Mental health outcomes (H2), using validated symptom scales for
      depression and quality-of-life, will also be examined using mixed models. Relevant
      demographic and clinical characteristics will be included in the logistic and mixed models,
      and main as well as interaction effects will be investigated.

      Aim 2 addresses level of engagement in weight loss treatment (i.e., number of MOVE! treatment
      sessions) and weight outcome. Engagement (H1) will be explored using Poisson regression on
      counts of MOVE! sessions completed using a binary treatment variable (MOVE! vs. MOVE!+CBT).
      The distribution of engagement will be reviewed to determine if there is over-dispersion (in
      which case quasi-likelihood estimation will be used to account for it). Models will include
      relevant covariates such as demographic and clinical characteristics. The treatment effect on
      weight (H2) will be examined with a mixed effects model, as described above, using
      longitudinal change in percent weight loss during the intervention and follow-up phases.
      Categorical analyses will also be performed comparing treatments on the proportion of
      participants achieving 5% weight losses using logistic regression analysis.

      Exploratory analyses will be performed on the metabolic outcomes (HbA1C, total cholesterol,
      HDL, LDL, triglycerides, systolic and diastolic blood pressure, and waist circumference)
      using mixed models. These outcomes were chosen for analysis to be consistent with interests
      of health services research although the investigators recognize that changes in these
      measures may not be sufficient to detect a difference. These analyses also could be important
      downstream in adding credibility in the eyes of patients, and providers, and could be used to
      enhance incentives for participation (or patient referral).

      Aim 3 is an examination of predictors, moderators and correlates of treatment outcome.
      Predictors are variables present at baseline that influence outcome regardless of treatment
      condition, and moderators are variables present at baseline that influence outcome depending
      on the treatment condition. Potential predictors and moderators (H1) will be explored with
      demographic (age and gender)81, and clinical characteristics (clinical severity and
      comorbidity) from the relevant literature on BED82,83. Logistic and multiple regression
      analyses, that have been detailed conceptually and analytically by Kraemer et al.84, will be
      used. Associations (H2) between changes in weight control strategies and physical activity,
      and weight loss 71 will be examined with correlation analyses.
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 (clinician-led Cognitive Behavioral Therapy).
primary purpose: Treatment
masking: Single (Care Provider)
masking description: Treating therapists will be blind to outcome data
measure: 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
description: 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.
measure: Change in Binge Episodes from Eating Disorder Examination Interview
time frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: The EDE is a clinician administered interview that is considered to be the gold standard for diagnosing eating disorders and assessing binge frequency.
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: The PHQ-9 is a 9-item version, is a self-report measure for the symptoms of depression.
measure: Change in PTSD Checklist (PCL-5)
time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of Post Traumatic Stress Disorder (PTSD)
measure: Weight and Eating Quality of Life (WE-QoL)
time frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: The WE-QoL is an 8-item self-report instrument for measurement of the impact weight and eating has on quality-of-life outcomes.
measure: Change in European Quality of Life (EuroQoL-5D)
time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: 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.
measure: Night Eating Questionnaire (NEQ)
time frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: The NEQ is a 14-item self-report instrument for the measurement of Night Eating Syndrome.
measure: 3 month post treatment
time frame: Total number sessions of CBT session attendance
description: CBT session attendance will be determined by the number of clinician-led individual sessions attended throughout the treatment.
measure: Total number sessions of MOVE! group (or TeleMOVE!) session attendance
time frame: 3 month post treatment, 9 month post treatment, 15 month post treatment
description: MOVE! group session attendance will be determined by the number of MOVE! group sessions attended throughout the treatment and follow-up phases.
measure: Change in BMI
time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: BMI will be calculated based upon self-reported height and weight.
measure: Change in Weight Control Strategies Scale (WCSS)
time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: 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
measure: Change in 24 Hour Food Frequency Questionnaire (24 Hour-FFQ)
time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: FFQ is a brief dietary screening tool that measures intake of foods related to weight gain and loss.
measure: Change in Godin Leisure Time Exercise Questionnaire (Godin)
time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: 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.
measure: Treatment satisfaction
time frame: 3 months post treatment
description: 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?").
measure: Impact of COVID-19
time frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: Brief 15-item questionnaire of the impact COVID-19 has had on patients currently participating in our research study. This survey will provide critical context to other data we are collecting about potential changes in participants eating behaviors over the course of our trial.
measure: Change in weight
time frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: All weights will be pulled from the electronic health record within two years before date of randomization.
measure: Diabetes Status (covariate)
time frame: Pre treatment
description: Status determined by a diabetes diagnosis in the electronic health record.
measure: Loss of Control Overeating Scale (LOCES)
time frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: A self-administered scale used to assess features of loss of control over eating.
measure: Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
time frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
description: A self-administered scale used to assess the features of food addiction. Scores range from 0-28 with higher scores reflecting worse outcome.
arm group label: MOVE!
arm group type: Active Comparator
description: Weight management delivered as Treatment-as-Usual
arm group label: MOVE!+CBT
arm group type: Experimental
description: Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating.
intervention type: Behavioral
intervention name: MOVE!
description: 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.
arm group label: MOVE!
intervention type: Behavioral
intervention name: MOVE!+CBT
description: 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.
arm group label: MOVE!+CBT
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Robin Meryl Masheb, PhD
role: Principal Investigator
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
facility: 
facility: 
country: United States
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.
PMID: 28271431
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.
PMID: 32107681
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.
PMID: 36973571
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 May 18:1-15. doi: 10.1080/00952990.2023.2207720. Online ahead of print.
PMID: 37200510
responsible party type: Sponsor
mesh term: Weight Loss
mesh term: Bulimia
mesh term: Feeding and Eating Disorders
mesh term: Binge-Eating Disorder
sharing ipd: No
ipd description: Unable to share Veteran data