Appetite, Binge Eating Behaviour, Food Cravings
Conditions
Keywords
Transcranial Direct Current Stimulation, tDCS, Appetite, Food Craving, Binge Eating, Eating Behavior, Home-based Intervention, Neuromodulation
Brief summary
This randomized, placebo-controlled, double-blind, parallel-design study aims to evaluate the neurophysiological effects of home-based transcranial direct current stimulation (tDCS) on appetite in adults with binge eating tendencies. Participants will be randomly assigned to either an active tDCS group or a sham stimulation group. After baseline assessments, participants will self-administer home-based tDCS twice daily for 4 weeks using a wearable wellness device. Appetite, eating behavior, body composition, dietary intake, and psychological outcomes will be assessed throughout the study to evaluate both the acute and chronic effects of repeated tDCS.
Detailed description
Obesity and binge eating behaviors are closely associated with abnormal appetite regulation and food craving. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that may modulate prefrontal cortical activity involved in appetite control and inhibitory regulation. The objective of this study is to investigate whether repeated home-based tDCS reduces appetite and improves eating-related behaviors in adults with binge eating tendencies. This study is a randomized, placebo-controlled, double-blind, parallel-design trial. A total of 100 participants aged 19 to 65 years with Binge Eating Scale (BES) scores of 18 or higher will be enrolled and randomized in a 1:1 ratio to either an active tDCS group or a sham stimulation group. Participants will perform home-based tDCS twice daily for 4 weeks using a wearable wellness scalp stimulation device. Appetite will be evaluated using repeated visual analogue scale (VAS) assessments to examine both acute and chronic effects of stimulation. Secondary outcome measures include changes in body composition, eating behavior questionnaires, food craving, binge eating severity, dietary intake, sleep quality, stress, depression, and anxiety. The findings of this study are expected to provide evidence regarding the neurophysiological effects of repeated home-based tDCS on appetite regulation and eating behavior.
Interventions
DEVICEActive Home-Based tDCS
Participants receive active home-based transcranial direct current stimulation (tDCS) using a wearable wellness scalp stimulation device. Active stimulation delivers 1.0 mA direct current for 20 minutes twice daily for 4 weeks.
DEVICESham Home-Based tDCS
Participants receive sham home-based transcranial direct current stimulation (tDCS) using the same wearable wellness scalp stimulation device. Sham stimulation delivers brief current only at the beginning and end of each session to maintain blinding.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 19 to 65 years * Binge Eating Scale (BES) score ≥18 * BMI ≥18.5 kg/m² * No significant weight loss or lifestyle changes during the previous 3 months * Stable chronic medical conditions (e.g., hypertension, diabetes, dyslipidemia) are allowed * Able to use an Android smartphone compatible with the study application (including a study phone if provided) * Able and willing to provide written informed consent
Exclusion criteria
* Unable to understand the study procedures or provide informed consent * Implanted pacemaker, implantable cardioverter-defibrillator, deep brain stimulator, cochlear implant, coronary stent, or other implanted metallic medical devices (dental implants and joint prostheses are allowed) * Diagnosis or treatment for a psychiatric or neurological disorder within the previous 3 months * Use of medications affecting appetite or body weight within the previous month * Use of medications affecting eating behavior or mood within the previous month * Pregnant or breastfeeding * Any medical condition judged by the investigator to interfere with study participation or interpretation of study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bedtime Appetite Visual Analog Scale Score Over 4 Weeks | Daily from Day 1 through Day 28 | Chronic change in appetite is assessed using the bedtime Appetite Visual Analog Scale (BT-VAS), measured once daily before bedtime from Day 1 through Day 28. The chronic effect is evaluated based on the change in bedtime Appetite VAS scores over time during the 4-week intervention period. The Appetite Visual Analog Scale ranges from 0 to 10, with higher scores indicating greater appetite. |
| Change in Appetite Visual Analog Scale Score Before and After Stimulation | Immediately before and after the first stimulation session on Days 7, 14, 21, and 28. | Acute change in appetite is assessed using the Appetite Visual Analog Scale (VAS) immediately before and after the first daily stimulation session on Days 7, 14, 21, and 28. The acute effect is defined as the change in Appetite VAS score from immediately before to immediately after stimulation. The Appetite Visual Analog Scale ranges from 0 to 10, with higher scores indicating greater appetite. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in General Food Cravings Questionnaire-Trait Score | Baseline to Week 4 | The General Food Cravings Questionnaire-Trait (G-FCQ-T) assesses trait-like general food craving. It consists of 21 items rated from 1 to 6, yielding a total score ranging from 21 to 126. Higher scores indicate greater trait food craving. Change in G-FCQ-T total score will be assessed from baseline to Week 4. |
| General Food Cravings Questionnaire-State Score | Days 7, 14, 21, and 28 | The General Food Cravings Questionnaire-State (G-FCQ-S) assesses current or momentary food craving. It consists of 15 items rated on a 5-point scale from 1 to 5, yielding a total score ranging from 15 to 75. Higher scores indicate greater current food craving. G-FCQ-S scores will be assessed repeatedly on Days 7, 14, 21, and 28 during the 4-week intervention period. |
| Change in Behavioral Inhibition System Score | Baseline to Week 4 | The Behavioral Inhibition System (BIS) scale consists of 7 items rated on a 4-point scale from 1 to 4, yielding a total score ranging from 7 to 28. Higher scores indicate greater sensitivity to punishment and stronger behavioral inhibition. Change in the BIS score will be assessed from baseline to Week 4. |
| Change in Behavioral Activation System Scores | Baseline to Week 4 | The Behavioral Activation System (BAS) scale consists of 13 items rated on a 4-point scale from 1 to 4 and comprises three subscales: Reward Responsiveness (5 items; score range, 5-20), Drive (4 items; score range, 4-16), and Fun Seeking (4 items; score range, 4-16). Higher scores indicate greater reward responsiveness, stronger goal-directed drive, and greater fun-seeking tendency, respectively. Changes in the BAS subscale scores will be assessed from baseline to Week 4. |
| Change in Eating Expectancy Inventory (EEI) Scores | Baseline and Week 4 | The Korean version of the Eating Expectancy Inventory (EEI) assesses expectancies regarding the psychological and emotional consequences of eating. The questionnaire consists of 28 items rated on a 7-point Likert scale from 1 to 7, yielding a total score ranging from 28 to 196. Higher scores indicate stronger endorsement of eating-related expectancies. Change in the EEI total score will be assessed from baseline to Week 4. |
| Change in Anticipated Negative Effects of Junk Food Score | Baseline to Week 4 | The Korean version of the Anticipated Effects of Food Scale (AEFS) assesses anticipated emotional responses to eating food. The negative affect subscale for junk food consists of 12 items rated from 1 to 6, yielding a total score ranging from 12 to 72. Higher scores indicate stronger anticipated negative emotional effects of eating junk food. Change in the subscale score will be assessed from baseline to Week 4. |
| Change in Anticipated Positive Effects of Junk Food Score | Baseline to Week 4 | The Korean version of the Anticipated Effects of Food Scale (AEFS) assesses anticipated emotional responses to eating food. The positive affect subscale for junk food consists of 12 items rated from 1 to 6, yielding a total score ranging from 12 to 72. Higher scores indicate stronger anticipated positive emotional effects of eating junk food. Change in the subscale score will be assessed from baseline to Week 4. |
| Change in Anticipated Negative Effects of Healthy Food Score | Baseline to Week 4 | The Korean version of the Anticipated Effects of Food Scale (AEFS) assesses anticipated emotional responses to eating food. The negative affect subscale for healthy food consists of 12 items rated from 1 to 6, yielding a total score ranging from 12 to 72. Higher scores indicate stronger anticipated negative emotional effects of eating healthy food. Change in the subscale score will be assessed from baseline to Week 4. |
| Change in Anticipated Positive Effects of Healthy Food Score | Baseline to Week 4 | The Korean version of the Anticipated Effects of Food Scale (AEFS) assesses anticipated emotional responses to eating food. The positive affect subscale for healthy food consists of 12 items rated from 1 to 6, yielding a total score ranging from 12 to 72. Higher scores indicate stronger anticipated positive emotional effects of eating healthy food. Change in the subscale score will be assessed from baseline to Week 4. |
| Change in Perceived Stress Scale Score | Baseline to Week 4 | The Perceived Stress Scale (PSS) assesses the degree to which situations in one's life are perceived as stressful. For the 10-item version (PSS-10), items are scored from 0 to 4 and summed after reverse scoring the positively stated items, yielding a total score ranging from 0 to 40. Higher scores indicate greater perceived stress. Change in PSS total score will be assessed from baseline to Week 4. |
| Change in Pittsburgh Sleep Quality Index Score | Baseline to Week 4 | The Pittsburgh Sleep Quality Index (PSQI) assesses subjective sleep quality and disturbances. Seven component scores are summed to yield a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality and greater sleep disturbance. Change in PSQI global score will be assessed from baseline to Week 4. |
| Change in Beck Depression Inventory-II Score | Baseline to Week 4 | The Beck Depression Inventory-II (BDI-II) assesses the severity of depressive symptoms. The 21 items are scored from 0 to 3 and summed to yield a total score ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms. Change in BDI-II total score will be assessed from baseline to Week 4. |
| Change in Beck Anxiety Inventory Score | Baseline to Week 4 | The Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms. The 21 items are scored from 0 to 3 and summed to yield a total score ranging from 0 to 63. Higher scores indicate greater severity of anxiety symptoms. Change in BAI total score will be assessed from baseline to Week 4. |
| Change in Binge Eating Scale Score | Screening to Week 4 | The Binge Eating Scale (BES) assesses the severity of binge eating symptoms and associated thoughts and behaviors. The scale consists of 16 items, with item responses assigned weighted scores ranging from 0 to 3. The total score ranges from 0 to 46, with higher scores indicating greater severity of binge eating symptoms. Change in the BES total score will be assessed from screening to Week 4. |
| Change in Body Weight | Baseline to Week 4 | Change in body weight measured in kilograms (kg) from baseline to Week 4. |
| Change in Body Mass Index | Baseline to Week 4 | Change in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²), from baseline to Week 4. |
| Change in Body Fat Percentage | Baseline to Week 4 | Change in body fat percentage, measured as a percentage (%), from baseline to Week 4. |
| Change in Waist Circumference | Baseline to Week 4 | Change in waist circumference measured in centimeters (cm) from baseline to Week 4. |
| Change in Dutch Eating Behavior Questionnaire Scores | Baseline to Week 4 | The Dutch Eating Behavior Questionnaire (DEBQ) assesses restrained, emotional, and external eating behavior using 33 items rated on a 5-point scale. The restrained eating subscale consists of 10 items, yielding a total score ranging from 10 to 50; higher scores indicate greater dietary restraint and stronger conscious control of food intake. The emotional eating subscale consists of 13 items, yielding a total score ranging from 13 to 65; higher scores indicate a greater tendency to eat in response to emotional states. The external eating subscale consists of 10 items, yielding a total score ranging from 10 to 50; higher scores indicate a greater tendency to eat in response to external food-related cues. Changes in the three DEBQ subscale scores will be assessed from baseline to Week 4. |
| Change in Skeletal Muscle Mass | Baseline to Week 4 | Change in skeletal muscle mass measured in kilograms (kg) using bioelectrical impedance analysis from baseline to Week 4. |
| Change in Reward-Based Eating Drive Scale Score | Baseline to Week 4 | The Reward-Based Eating Drive Scale-13 (RED-13) assesses reward-based eating, including loss of control over eating, lack of satiety, and preoccupation with food. The 13 items are rated from 1 to 5 and summed to yield a total score ranging from 10 to 65. Higher scores indicate greater reward-based eating drive. Change in RED-13 total score will be assessed from baseline to Week 4. |
Contacts
CONTACTHyun young Noh, MD
PRINCIPAL_INVESTIGATORHyung jin Choi, MD-PhD
Seoul National University College of Medicine
Outcome results
None listed