Inhibitory Control Training and iTBS for Excess Weight: Behavioral and Brain Changes (InhibE).

NCT06668077 | Recruiting

• 1 other identifier: SICEIA-2024-000656
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

People with excess weight (EW) are characterized by high impulsivity, high levels of craving for high-calorie foods, deficits in inhibitory control, and maladaptive decision-making. These characteristics are related, at the brain level, to alterations in the activation of areas such as the dorsolateral prefrontal cortex (DLPFC) and its connectivity. The proposed intervention seeks to target these issues. Thus, the present study aims to characterize the effects of neuromodulation with intermittent theta burst transcranial magnetic stimulation (iTBS) of the DLPFC alone and in combination with inhibitory control training to produce brain, cognitive and behavioral changes, and modify altered biological parameters in people with EW. Participants will be randomly allocated to one of three groups: (1) a group that will receive active iTBS of the DLPFC combined with inhibitory control training with a food Go/No-go paradigm, (2) a group that will receive active iTBS of the DLPFC only, and (3) a control group that will receive sham iTBS. It is hypothesized that the combined intervention will obtain better results that the neuromodulation alone, and that both interventions, compared to sham iTBS, will achieve: (i) decreased body mass index, (ii) decreased craving, (iii) modified brain connectivity and activation both at rest and linked to task performance with food stimuli, (iv) improved anthropometric measures (waist circumference and waist-to-hip and waist-to-height ratios), (v) improved eating and exercise behaviors (decreased caloric intake and increased frequency and time of physical activity), (vi) improved emotional symptoms and emotional eating (depression, anxiety, emotional regulation, emotional eating, reward-related eating, non-homeostatic eating), (vii) improved cognitive abilities (motor and cognitive inhibition, delay of gratification, impulsivity, working memory, cognitive flexibility and decision making), (viii) changes in biological parameters associated to the interventions (plasma and microbiota), and (ix) advantages in cost-effectiveness and cost-utility based on economic evaluation analyses.

Conditions

Overweight and Obesity; Inhibition, Psychological

Keywords

excess weight; overweight; inhibitory control; cognitive training; iTBS

Outcome Measures

Primary Outcomes (2)

• Body Mass Index (BMI)

  Change in BMI: Weight and height will be combined to report BMI in kg/m\^2. Weight will be obtained in kilograms with a digital scale (TANITA Corporation of America) and height in meters with a measuring rod (SECA Tape Measure 206).

  Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)

• Changes in brain activation during a inhibitory control task (neuroimaging measures)

  Food Go/No-go task (Based on the FoodTrainer App; Lawrence et al., 2015): Pictures appear and afterwards a green (Go signal) or red (No-Go signal) circle appears around them. Participants are instructed to score points by answering with a knob if the image is surrounded by a green circle, but not to press when the image is surrounded by a red circle. The presentation of the images is the same as in the FoodTrainer application: 50% of the images are food, with 100% of the healthy ones being presented under the 'Go' condition and 100% of the unhealthy ones under the 'No-Go' condition. The remaining 50% are non-food images, with 50-50% paired with 'Go' and 'No-Go' cues. In addition, participants can choose which categories of unhealthy foods they want to train. Brain activation to Go vs. No-Go stimuli and food vs. non-food stimuli will be compared. The task will be analysed to assess the brain activity associated with the task, using a psychophysiological interaction analysis(PPI).

  Pre-treatment assessment (week 2) and post-treatment assessment (week 6)

Secondary Outcomes (23)

• Changes in Food decision-making (neuroimaging measures)

  Pre-treatment assessment (week 2) and post-treatment assessment (week 6)

• Changes in Brain connectivity at rest (neuroimaging measures)

  Pre-treatment assessment (week 2) and post-treatment assessment (week 6)

• Changes in White matter integrity (neuroimaging measures)

  Pre-treatment assessment (week 2) and post-treatment assessment (week 6)

• Waist-to-height ratio (WHtR). Mean change from baseline at post-intervention

  Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)

• Food Craving. Mean change from baseline at post-intervention

  Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)

Other Outcomes (25)

• Descriptive measures

  Pre-treatment assessment (week 2)

• Depression Symptoms. Screening

  Pre-treatment assessment (week 2)

• Anxiety Symptoms. Screening

  Pre-treatment assessment (week 2)

Study Arms (3)

Combined intervention

EXPERIMENTAL

Experimental: Active iTBS of the DLPFC combined with inhibitory control training. An experimental group will receive: i) an informative session; ii) 4 pre treatment sessions (one assessment session with questionnaires, one with fMRI and one with biological samples. Also, a counselling session on diet and on physical exercise); iii) participate in 2 weekly individual intervention sessions that consist of iTBS of the left DLPFC (10 min) followed immediately by inhibitory control training for 10 minutes; iv) 3 sessions of post treatment assessment (one with questionnaires, one with fMRI and one with biological samples); v) 2 follow-up assessment sessions (3 months after completing the intervention) to repeat questionnaires and biological samples

Device: iTBS of the left DLPFC; Behavioral: Inhibitory control training

Active iTBS

ACTIVE COMPARATOR

Experimental: Active iTBS of the DLPFC only. An experimental group will receive: i) an informative session; ii) 4 pre treatment sessions (one assessment session with questionnaires, one with fMRI and one with biological samples. Also, a counselling session on diet and on physical exercise); iii) participate in 2 weekly individual intervention sessions that consist of iTBS of the left DLPFC that will last about 10 minutes each; iv) 3 sessions of post treatment assessment (one with questionnaires, one with fMRI and one with biological samples); v) 2 follow-up assessment sessions (3 months after completing the intervention) to repeat questionnaires and biological samples

Device: iTBS of the left DLPFC

Sham iTBS

SHAM COMPARATOR

Control: iTBS of the vertex (sham). The control group will receive: i) an informative session; ii) 4 pre treatment sessions (one assessment session with questionnaires, one with fMRI and one with biological samples. Also, a counselling session on diet and on physical exercise); iii) participate in 2 weekly individual intervention sessions that consist of iTBS of the vertex that will last about 10 minutes each; iv) 3 sessions of post treatment assessment (one with questionnaires, one with fMRI and one with biological samples); v) 2 follow-up assessment sessions (3 months after completing the intervention) to repeat questionnaires and biological samples

Device: iTBS of the vertex

Interventions

iTBS of the left DLPFC DEVICE

Participants will receive a 3 minutes active theta burst transcranial magnetic stimulation (iTBS) of the DLPFC of the left hemisphere while not performing any other task

Also known as: Active iTBS

Active iTBS; Combined intervention

iTBS of the vertex DEVICE

Participants will receive a 3 minutes active theta burst transcranial magnetic stimulation (iTBS) of the vertex while not performing any other task

Also known as: Sham iTBS

Sham iTBS

Inhibitory control training BEHAVIORAL

Computerized cognitive training. Participants will perform the task of the FoodT app for 10 minutes during two weeks (taking advantage of time of maximum brain potentiation after the iTBS, Rossi et al., 2009). Images of food and non-food appear on the left, right or centre of the smart phone screen and participants must touch it (or not, depending on the cue) with their index finger as quickly as possible. Participants earn points for correct tap responses and lose points for incorrect tap responses. If the image has a green border around it, participants must tap the image and win 1 point. But if the image has a red border around it, participants must inhibit the tapping response, otherwise 1 point will be lost. Participants must respond as quickly and accurately as possible. Pictures of healthy and unhealthy foods are always paired with the Go and the No-Go signal, respectively. Non-food images are paired 50% of the time with the Go and the No-Go signal

Also known as: FoodT

Combined intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 25 and 39.9
• Age between 18 and 60 years
• Proficiency in the Spanish language
• Right lateral dominance to avoid differential effects due to cortical hemispheric specialization

You may not qualify if:

• Traumatic, digestive, metabolic or systemic disorders that affect the central nervous system, autonomic or endocrine
• Severe psychopathological disorders and suicidal ideation or treatment for depression
• Eating disorders
• Contraindication for performing fMRI (pregnancy, metal implants, etc.) or iTBS (tinnitus, dizziness, surgical interventions, diseases or drugs that affect the CNS, etc.)

Sponsors & Collaborators

• Raquel Vilar López: lead
• Government of Spain: collaborator

Study Sites (1)

Mind, Brain and Behavior Research Center at University of Granada (CIMCYCUGR)

Granada, Spain

RECRUITING

Related Links

• Project website

MeSH Terms

Conditions

Overweight; Obesity; Inhibition, Psychological

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Raquel Vilar López, Ph.D.

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel Vilar López, Ph.D.

CONTACT

+34699407282; rvilar@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The psychologists that conduct the assessments (screening, assessment sessions and follow-ups) will be blinded to the group allocation during the whole project. Further, all participants will be blind to their condition. Also, the people who perform the statistical analyses will be blind to the condition of the groups, through the coding of the interventions. Only the therapist performing the interventions will not be blind to the allocation of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel group randomized controlled trial

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 31, 2024
• Study Start: November 30, 2024
• Primary Completion: November 30, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee and who provide a methodologically sound proposal. Proposals should be directed to rvilar@ugr.es

Locations

ES (1)