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This study is a randomized clinical trial to test the effect of a type of non-invasive brain stimulation on the response to a behavioral intervention designed to enhance cognitive control over food cravings in obese and overweight women. The brain stimulation is called transcranial Direct Current Stimulation (tDCS). All eligible participants will engage in a behavioral intervention known to enhance control over food cravings and will be randomly assigned to receive either tDCS or sham stimulation to the prefrontal cortex of the brain.
This study is a randomized clinical trial to test the effect of a type of non-invasive brain stimulation on the response to a behavioral intervention designed to enhance cognitive control over food cravings in obese and overweight women. The brain stimulation is called transcranial Direct Current Stimulation (tDCS) which is a form of stimulation that delivers a low amplitude electrical current to the brain via the scalp (i.e. trans-cranial) to modify brain activity.
All eligible participants will engage in a behavioral intervention (Go-No Go task), known to enhance control over food cravings, and will be randomly assigned to receive either tDCS or sham stimulation to the right prefrontal cortex of the brain during 8 20-min daily sessions.
Primary outcome: score changes in eating behaviors scales (YFAS and TFEQ), scales will be applied at baseline and at the end of the 8 brain stimulation sessions.
Secondary outcomes: changes in diet, brain function (brain MRI/MRS) Other outcomes: food cravings scales and impulse control scales and cognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS and Go-No Go task | Experimental | Certain randomly assigned participants will receive tDCS to the DLPFC for 8 daily 20-minute sessions, with a TDCS amplitude of 2 mAmps. During the tDCS session, individuals will perform a 10-min computerized Go-No Go task |
|
| Sham brain stimulation and Go-No Go task | Sham Comparator | Certain randomly assigned participants will receive Sham Stimulation to the DLPFC for 8 daily 20-min sessions. The Sham stimulation is an inactive form of stimulation. During the sham brain stimulation session, individuals will perform a 10-min computerized Go-No Go task |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | Individuals undergo 20min daily sessions receiving actual tDCS to the brain (to the right DLPFC: dorsolateral prefrontal cortex) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Yale Food Addiction Scale scores | Yale Food Addiction Scale (YFAS26) that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse). | Scores measured at baseline and at up-to 2 weeks after the intervention |
| Change in Three-Factor Eating Questionnaire scores | Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse). | Scores measured at baseline and at up-to 2 weeks after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in brain neural activity by functional Magnetic Resonance Imaging ( fMRI) | Significant change in brain activity of the prefrontal cortex (area involved in the inhibitory control of food intake) measured by modification of BOLD (Blood-Oxygen-Level-Dependent) signal in fMRI evoked responses to visual food-cues | Brain function at baseline and up-to 2 weeks after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Diet (3-day food intake record) | 3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients | Values measured at baseline and at up-to 2 weeks after the intervention |
| Change in Yale Food Addiction Scale scores at 3-months post-intervention |
Inclusion Criteria:
BMI between 28 and 40 kg/m2 high scores in the Yale-Food Addiction-Scale right-handed
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia P Sanmiguel, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Los Angeles | California | 90095 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 24, 2023 | |
| Reset | Jul 14, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 24, 2023 | Jul 14, 2023 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D000073932 | Food Addiction |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| Sham brain stimulation | Device | Individuals undergo 20min daily sessions receiving sham stimulation to the brain (to the right DLPFC: dorsolateral prefrontal cortex) |
|
| Go-No GO task | Behavioral | During the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go) |
|
| Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS) | Significant change in brain metabolites concentration at the prefrontal cortex (area involved in the inhibitory control of food intake) measured with Magnetic Resonance spectroscopy | Brain MRS at baseline and up-to 2 weeks after the intervention |
Yale Food Addiction Scale (YFAS26) that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse). |
| At 3-months after intervention |
| Change in Three-Factor Eating Questionnaire scores at 3-months post-intervention | Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse). | At 3-months after intervention |
| Cognitive function assessment | Multiple Abilities Self-Report Questionnaire (MASQ), a self-report measure comprising items from five cognitive domains; language, visuo-perceptual, verbal memory, visual memory, and attention. The maximum score for the whole scale is 190 points. Higher scores correlate with better function. | Measured at baseline and up-to 2 weeks after the intervention |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016739 | Behavior, Addictive |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |