Inhibitory Control Training and iTBS for Excess Weight: Behavioral and Brain Changes (InhibE).
NCT06668077, Not applicable, Recruiting, Raquel Vilar López
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Inhibitory Control Training and iTBS for Excess Weight: Behavioral and Brain Changes (InhibE). | ClinicalTrials.gov |
| NCT number | NCT06668077 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 141 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Raquel Vilar López | ClinicalTrials.gov |
| Conditions | Overweight and Obesity, Inhibition, Psychological | ClinicalTrials.gov |
| Interventions | iTBS of the left DLPFC, iTBS of the vertex, Inhibitory control training | ClinicalTrials.gov |
| First posted | 2024-10-31 | ClinicalTrials.gov |
| Last updated | 2025-02-14 | ClinicalTrials.gov |
Registered outcomes 50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Body Mass Index (BMI) | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | 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). | ClinicalTrials.gov |
| Primary | Changes in brain activation during a inhibitory control task (neuroimaging measures) | Pre-treatment assessment (week 2) and post-treatment assessment (week 6) | 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). | ClinicalTrials.gov |
| Secondary | Changes in Food decision-making (neuroimaging measures) | Pre-treatment assessment (week 2) and post-treatment assessment (week 6) | The Neveu et al. (2018) task will be used, which consists of three phases: two rating phases and one decision phase with 50 food images. Participants have to answer on a 5-point Likert scale how healthy they consider the food to be (block 1) and how much they like the taste of the food (block 2). In the third block, the participant decides whether they prefer to eat a neutral reference food (calculated from the previous two blocks) or an alternative food. These forced choices lead to cognitive conflict when the reference food is considered tastier and the alternative food healthier or vice versa. Among trials with cognitive conflict, the choice of the healthier food is defined as a controlled choice, and the choice of the tastier food as an uncontrolled choice. Activation will be compared between the controlled vs. uncontrolled choice conditions. The task will be analysed to assess the brain activity associated with the task, using a psychophysiological interaction analyses (PPI). | ClinicalTrials.gov |
| Secondary | Changes in Brain connectivity at rest (neuroimaging measures) | Pre-treatment assessment (week 2) and post-treatment assessment (week 6) | Participants will be instructed to remain still, with their eyes closed, trying not to think about anything in particular for 9 minutes to obtain images to study the resting connectivity of different brain networks. On the one hand, an independent component analyses (ICA) will be performed, which will allow comparison of the different brain networks, as a whole, between the groups, with special interest in those that have been shown to be altered in the PD population. On the other hand, seed-based connectivity analyses will be performed, in which changes in functional connectivity between the CPFDL and the rest of the brain will be observed. | ClinicalTrials.gov |
| Secondary | Changes in White matter integrity (neuroimaging measures) | Pre-treatment assessment (week 2) and post-treatment assessment (week 6) | Participants will be asked to remain still for 10 minutes to obtain diffusion tensor imaging (DTI) which provides indirect measurements of the architecture and connectivity of white matter fibres. The study of the DTI images will be carried out with the FSL programme, which allows the integrity of the white matter of the different groups to be measured by evaluating the fractional anisotropy (FA) and apparent diffusion coefficient (ADC) maps. | ClinicalTrials.gov |
| Secondary | 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) | To take these measurements at home, participants should ask someone for help and follow our instructions. WHtR results from WC divided by the height measured standing with heels close together and trunk erect. | ClinicalTrials.gov |
| Secondary | Food Craving. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Change in Food Craving. Food Craving Questionnaire State-reduced (FCQ-S-r)consists of 15 items to be scored on a 5-point scale ranging from strongly disagree to strongly agree. A higher score indicates higher state of craving at the time of the assessment | ClinicalTrials.gov |
| Secondary | Eating behaviour. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Diet information during the last year (pre-treatment), two last weeks (post-treatment) and 3 last months (follow-up) will be collected through a 52-item Food frequency questionnaire (CFA). Participants must record quantities of all the foods and drinks consumed during those periods. Data are transformed into total calories and calories from fats, carbohydrates, and sugars | ClinicalTrials.gov |
| Secondary | Physical activity behaviour. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | International Physical Activity Questionnaire (IPAQ; www.ipaq.ki.se): is a questionnaire with 7 questions on physical activity during the last week, as well as walking and sitting time.It evaluates physical activity related to work, activity at home and free time determines the degrees of activity based on the metabolic equivalents (MET) consumed.Higher scores indicate greater physical activity | ClinicalTrials.gov |
| Secondary | Exercise adherence. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | The following question will be asked using a visual analogue scale (VAS): In the last 2 weeks or 3 months, to what extent did you follow the exercise guidelines given to you by the programme's physical trainer? (0 = I did not follow the exercise recommendations at all; 100 = I absolutely followed the exercise recommendations). | ClinicalTrials.gov |
| Secondary | Adherence to diet. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | The following question will be asked using a visual analogue scale (VAS): In the last 2 weeks or 3 months, how well did you follow the dietary guidelines given by the nutritionist in the programme (0 = I did not follow the diet at all; 100 = I followed the diet absolutely). | ClinicalTrials.gov |
| Secondary | Depression symptoms. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Beck Depression Inventory will be administered to test depression symptoms.The scores range from 0 to 63 points. The higher the score, the greater the severity of depressive symptoms | ClinicalTrials.gov |
| Secondary | Anxiety and Stress. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | The Depression Anxiety Stress Scale-21 (DASS-21) will be used, taking into account scores on the stress and anxiety subscales. The scores for both subscales range from 0 to 21, a higher score indicating higher anxiety or stress | ClinicalTrials.gov |
| Secondary | Non homeostatic eating. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Dutch Eating Behaviour Questionnaire (DEBQ) will be administered to assess restrictive eating behaviours related to external cues and emotional states. Higher scores in each subscale reflect higher level of restrained, emotional, and external eating, respectively.The DEBQ uses a 5-point Likert scale, ranging from never (1) to very often (5). The average score is calculated for each subscale by adding scores obtained from individual items and dividing them by the number of items included in a subscale (mean range: 1-5). | ClinicalTrials.gov |
| Secondary | Reward-related eating. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Reward-Based Eating Scale (RED) is a 13 items questionnaire that evaluates worries about foods, losing intake control and absence of satiety. Higher scores reflect higher reward-based eating drive. | ClinicalTrials.gov |
| Secondary | Emotional eating. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Coping subscale of the Palatable Eating Motives Scale (PEMS) will be used to evaluate the intentionality for eating palatable foods to face negative emotions. The coping subscale includes items that are scored on a 5-point Likert-type scale, the total range being from 5 to 25 points. Low scores indicate that the person rarely resorts to the consumption of pleasant foods as a strategy to cope with negative emotions or stressful situations. High scores suggest that the person frequently uses palatable food as a strategy to cope with stress or negative emotions, which may be related to unhealthy eating habits or emotional eating patterns. | ClinicalTrials.gov |
| Secondary | Emotion Regulation Strategies. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | The Emotion Questionnaire (ERQ) consists of 10 items to examine cognitive reappraisal and expressive suppression strategies. In cognitive reappraisal the highest score (42) is associated with better emotional outcomes while in expressive suppression the highest score (28) is linked to poorer well-being. Each item is rated on a Likert scale from strongly disagree (1) to strongly agree (7). | ClinicalTrials.gov |
| Secondary | Motor inhibition. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Motor inhibition will be assessed using FoodT. In the FoodT app reaction time for the high-calorie and low-calorie foods paired with the go and the no-go signal. The average response time for go and no-go items will be calculated according to the type of images (appetizing and healthy foods), and commission errors will be recorded. | ClinicalTrials.gov |
| Secondary | Cognitive inhibition. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Using a Stroop task with food, the interference of food-related words on task performance can be measured as an assessment of cognitive inhibition. | ClinicalTrials.gov |
| Secondary | Delay of gratification. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Score on the Food Delay Discounting will be used to measure the sensitivity to immediate rewards vs higher value rewards delayed. The participant\'s choices are recorded for each trial. Each trial varies in terms of the amount of reward and the amount of time to wait. To model the decisions, a hyperbolic discounting function is generally used. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Go/No-Go Task | Primary outcome | ConductCognition |
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Delay Discounting | Secondary outcome | ConductCognition |
| Iowa Gambling Lite | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)