Inhibitory Control Training for Excess Weight: Behavioural, Cognitive and Anthropometric Changes
NCT06600100, 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 for Excess Weight: Behavioural, Cognitive and Anthropometric Changes | ClinicalTrials.gov |
| NCT number | NCT06600100 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 54 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Raquel Vilar López | ClinicalTrials.gov |
| Conditions | Overweight and Obesity, Inhibition, Psychological | ClinicalTrials.gov |
| Interventions | Inhibitory control training, Placebo Inhibitory control training | ClinicalTrials.gov |
| First posted | 2024-09-19 | ClinicalTrials.gov |
| Last updated | 2025-03-25 | ClinicalTrials.gov |
Registered outcomes 29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Body Mass Index (BMI). Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | BMI is a measure of body fat based on height and weight. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m\^2. Height and weight will be obtained with a pharmacy digital weight. | 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 | Waist circumference (WC). 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. WC will be measured in cm with a tape around the waist, just above the navel. | ClinicalTrials.gov |
| Secondary | Waist-to-hip ratio (WHR). 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. WHR results from WC divided by the hip circumference in cm (tape placed at the maximum prominence of the buttocks). | 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 | 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 | 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 | 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 | 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 |
| Secondary | Inhibition and activation systems. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | This will be assessed using the Punishment Sensitivity and Reward Sensitivity Questionnaire (PSRSQ) of 48 items. Responses in the scale are in a "yes/no" format. Higher punishment sensitivity scores are associated with lower number of punishable errors while higher reward sensitivity punctuations are linked to higher number of passive avoidance errors. | ClinicalTrials.gov |
| Secondary | Self-reported impulsivity. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Self-reported impulsivity will be measured with Impulsive behaviour scale (UPPS-P). It consists of 20 items scored on a four point Likert scale, ranging from strongly agree (1) to strongly disagree (4). Higher scores mean worse outcome in impulsivity, while lower scores are related to better self-control and regulation | ClinicalTrials.gov |
| Secondary | Working Memory. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Working Memory will be assessed using N-back Task score based on accuracy and reaction times. Higher accuracy scores indicate stronger working memory and attention, while faster reaction times are linked to quicker processing speed and decision-making. | ClinicalTrials.gov |
| Secondary | Cognitive flexibility. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18) | Wisconsin Card Sorting Test will be administered to measure shift strategy in response to changing contingencies. There are128 trials where more correct responses, fewer perseverative and non perseverative errors, and more completed categories (max 6) are related to better performance. | 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 6
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 |
|---|---|---|
| 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)