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CHARGE: Controlling Hunger and ReGulating Eating (CHARGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03678766
Recruitment Status : Active, not recruiting
First Posted : September 20, 2018
Last Update Posted : April 18, 2022
Sponsor:
Collaborators:
San Diego Veterans Healthcare System
United States Department of Defense
Information provided by (Responsible Party):
Kerri Boutelle, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE September 18, 2018
First Posted Date  ICMJE September 20, 2018
Last Update Posted Date April 18, 2022
Actual Study Start Date  ICMJE September 30, 2018
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • Attendance [ Time Frame: Post-Treatment (5 months following baseline) ]
    The number of treatment visits attended
  • Acceptability [ Time Frame: Post-Treatment (5 months following baseline) ]
    Average likert ratings to questions, such as "How much did you enjoy the treatment?" and "How helpful did you find the treatment?"
  • Binge Eating as measured by the Eating Disorder Examination (EDE) [ Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks ]
    Diagnosis of Binge Eating Disorder (BED) and subclinical BED, number of OBEs (large amount of food and loss of control), objective overeating episodes (large amount of food without loss of control), and SBEs (lack of large amount of food with loss of control) determined by responses to the EDE.
  • Binge Eating as measured by the Binge Eating Scale (BES) [ Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks ]
    Dimensional score of binge eating consisting of items to describe binge eating behaviors and feelings and cognitions associated with binge eating.
  • Binge Eating as measured by the Eating Disorder Examination-Questionnaire (EDE-Q) [ Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks ]
    Three question items from the questionnaire to calculate the number of binge eating episodes and number of days participants experienced a binge eating episode.
  • Body Mass Index (BMI) as measured by weight and height [ Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks ]
  • Energy intake [ Time Frame: Changes from baseline at an average of 20 weeks and 44 weeks ]
    Calorie intake estimated by 24-hour dietary recalls on 3 non-consecutive days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • Satiety Responsiveness [ Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks ]
    Self-reported satiety responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
  • Food Responsiveness [ Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks ]
    Self-reported food responsiveness measured by the Adult Eating Behavior Questionnaire (AEBQ)
  • Reward-Based Eating [ Time Frame: Changes from baseline at an average of 9 weeks, 20 weeks, and 44 weeks ]
    Scales to evaluate reward-related eating measured by the Reward-Based Eating Drive Scale (RED-13)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CHARGE: Controlling Hunger and ReGulating Eating
Official Title  ICMJE Targeting Food Cue Reactivity and Satiety Sensitivity to Decrease Binge Eating and Weight
Brief Summary The objectives of this proposed study are: 1) to evaluate feasibility and acceptability of a novel intervention, Regulation of Cues (ROC), and Cognitive Behavior Therapy (CBT), and 2) to evaluate the efficacy of both treatments on reduction of binge eating and weight loss among 120 Veterans with subclinical or clinical Binge Eating Disorder (BED) with comorbid overweight/obesity (OW/OB).
Detailed Description The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Schachter's Externality Theory. This study will compare ROC with Cognitive Behavior Therapy for individuals with Binge Eating Disorder. The investigators will recruit and randomize 120 male and female Veterans with BED and subclinical BED with comorbid overweight/obesity, provide 5 months of treatment and follow participants for 6-months post-treatment. Participants will complete assessments at baseline, mid-treatment (week 9), post-treatment (week 20), and 6-month follow-up (week 44). This study will be the first to contribute to a body of literature developing treatments for BED and overweight/obesity in the Veterans Affairs (VA) and/or military health care systems.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Binge-Eating Disorder
  • Overweight
  • Obesity
Intervention  ICMJE
  • Behavioral: Regulation of Cues (ROC)
    Participants are provided information about basic learning theory and how physiological responses to food cues develop and can be managed. Lack of sensitivity to appetite and satiety cues and increased sensitivity to food cues will be discussed. Coping skills are presented to assist in mastery and toleration of food cue sensitivity. Participants will complete experiential learning exercises with food, and taught to monitor their hunger, satiety, and cravings. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs.
    Other Name: ROC
  • Behavioral: Cognitive Behavior Therapy (CBT)
    Participants are taught to identify problems in eating, thinking, and mood patterns that served to trigger binge episodes through self-monitoring and to gradually develop alternative patterns aimed at facilitating healthy, binge-free eating patterns. Participants are taught to eat a healthy variety of foods and reducing the avoidance of "forbidden" foods that are typically consumed during a binge.
    Other Name: CBT
Study Arms  ICMJE
  • Experimental: Regulation of Cues (ROC)
    The ROC program provides psychoeducation, coping skills, self-monitoring and experimental learning.
    Intervention: Behavioral: Regulation of Cues (ROC)
  • Experimental: Cognitive Behavior Therapy (CBT)
    CBT provides coping skills, self-monitoring, and goal setting.
    Intervention: Behavioral: Cognitive Behavior Therapy (CBT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 15, 2022)
131
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2018)
120
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. All participants will be Veterans between the ages of 18-65 meeting criteria for overweight, with a 45≥ BMI ≥25.
  2. Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for BED or subclinical BED
  3. Participants will be willing and able to participate in assessment visits and treatment sessions at University of California, San Diego (UCSD).
  4. Participants will be able to provide data in English through interviews and questionnaires and understand treatment materials in English.
  5. Participants will be willing to maintain contact with the investigators for 11 months.
  6. Participants will be free of serious or unstable medical (current symptoms of angina, stroke, heart disease or other serious medical condition that would make physical activity unsafe or impossible at a moderate level) or psychiatric illness (i.e., active suicidal ideation, history of suicide attempt within 1 year, current unmanaged psychosis, manic episode, anorexia nervosa, bulimia nervosa, or substance abuse within the past year) or psychosocial instability (e.g., homelessness) that could compromise study participation.
  7. Participants will be free from conditions in which exercise or weight loss will be detrimental to the participant's health (e.g., pregnancy); pharmacotherapy for obesity or binge eating disorder (e.g., Orlistat or Meridia) or bariatric surgery within the past 6 months or planning to start such treatments in the next 11 months.
  8. Participants will not be moving out of the San Diego area for the duration of their study enrollment (11 months).
  9. Participants will not be pregnant, planning to get pregnant in the 11-month study period or lactating.
  10. Participants will not be participating in group or individual psychotherapy for binge eating or weight management.
  11. Participants with medical or psychological problems or taking medications that could make adherence with the study protocol difficult or dangerous will not be included.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03678766
Other Study ID Numbers  ICMJE 181015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kerri Boutelle, University of California, San Diego
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Diego
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • San Diego Veterans Healthcare System
  • United States Department of Defense
Investigators  ICMJE
Principal Investigator: Kerri Boutelle, Ph.D UCSD
PRS Account University of California, San Diego
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP