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OpenTrials
Completed

NCT Number: NCT03678766

CHARGE: Controlling Hunger and ReGulating Eating

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).

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Key information

Conditions

Binge-Eating Disorder Body Weight Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants will be Veterans between the ages of 18-65 meeting criteria for overweight, with a 45≥ BMI ≥25.
  • Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for BED or subclinical BED
  • Participants will be willing and able to participate in assessment visits and treatment sessions at University of California, San Diego (UCSD).
  • Participants will be able to provide data in English through interviews and questionnaires and understand treatment materials in English.
  • Participants will be willing to maintain contact with the investigators for 11 months.
  • 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.
  • 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.
  • Participants will not be moving out of the San Diego area for the duration of their study enrollment (11 months).
  • Participants will not be pregnant, planning to get pregnant in the 11-month study period or lactating.
  • Participants will not be participating in group or individual psychotherapy for binge eating or weight management.
  • Participants with medical or psychological problems or taking medications that could make adherence with the study protocol difficult or dangerous will not be included.

Treatment and study plan

Regulation of Cues (ROC)

Behavioral

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 names: ROC

Cognitive behavior therapy (CBT)

Behavioral

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 names: CBT

Primary outcomes

  1. Attendance

    Time frame: Post-Treatment (5 months following baseline)

    The number of treatment visits attended

  2. 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?"

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • San Diego Veterans Healthcare System
  • United States Department of Defense

Registry information

Official study title

Targeting Food Cue Reactivity and Satiety Sensitivity to Decrease Binge Eating and Weight

Acronym: CHARGE

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 20, 2018
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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