Inhibitory Control Training for Excess Weight: Behavioural, Cognitive and Anthropometric Changes

NCT06600100 | Recruiting

• 1 other identifier: PID2022-137524OB-I00
• Study Type: interventional
• Target: 54
• 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. The proposed intervention seeks to target these issues. Thus, the present study aims to determine the effectiveness of combining inhibitory control training with usual treatment (diet and physical exercise) in treating people with EW to produce cognitive, behavioral and anthropometric changes. Participants will be randomly allocated to one of two groups: 1) the experimental group that would receive active inhibitory control training and (2) the active control group that will receive placebo inhibitory control training. Both groups will receive individualized diet and physical exercise guidelines. Training requires to inhibit responding to certain foods presented during computerized tasks. Using a food Go/No-Go paradigm, individuals are asked to press a button when a Go cue is presented next to an image and to refrain from pressing a button when a No-Go cue (e.g., a bold frame) is presented. In the experimental group, pictures of healthy and unhealthy foods are always paired with the Go and the No-Go signal, respectively whereas in the control group healthy and unhealthy foods are paired 50% of the time with the Go and 50% with the No-Go signal. It is hypothesized that the experimental intervention would be effective improving (i) Body Mass Index (BMI), (ii) food craving, (iii) anthropometric measures (waist circumference and waist-to-hip and waist-to-height ratios), (iv) eating and physical exercise behaviors (decreased caloric intake and increased frequency and time of physical activity), (v) emotional symptoms and emotional eating (depression, anxiety, emotional regulation, emotional eating, reward-related eating, non-homeostatic eating), and (vi) cognitive abilities (motor and cognitive inhibition, delay of gratification, impulsivity, working memory, cognitive flexibility and decision making).

Conditions

Overweight and Obesity; Inhibition, Psychological

Keywords

excess weight; overweight; inhibitory control training; FoodT

Outcome Measures

Primary Outcomes (1)

• Body Mass Index (BMI). Mean change from baseline at post-intervention

  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.

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

Secondary Outcomes (20)

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

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

• 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)]

• 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)]

• 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)]

• Eating behaviour. Mean change from baseline at post-intervention

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

Other Outcomes (8)

• 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 (2)

Inhibitory control training

EXPERIMENTAL

Inhibitory control training using the active version of the FoodT App. An experimental group will receive: i) an informative session; ii) 3 pre-treatment sessions (one assessment with questionnaires and two counselling sessions: one on diet and one on physical exercise); iii) A psychology session in which the investigator will explain the task to participants and the procedure for the next two weeks. A daily reminder will be sent by WhatsApp to the participants' phone to train for 10 minutes a day from Monday to Friday for two weeks; iv) a session of post treatment assessment (questionnaires); v) one follow-up session three months after completing the intervention to repeat the evaluation

Behavioral: Inhibitory control training

Placebo inhibitory control training

PLACEBO COMPARATOR

Placebo inhibitory control training using the placebo version of the FoodT App. The placebo group will receive: i) an informative session; ii) 3 pre-treatment sessions (one assessment with questionnaires and two counselling sessions: one on diet and one on physical exercise); iii) A psychology session in which the investigator will explain the task to participants and the procedure for the next two weeks. It won't be necessary to meet every day; A daily reminder will be sent by WhatsApp to the participants' phone to train for 10 minutes a day from Monday to Friday for two weeks; iv) a session of post treatment assessment (questionnaires); v) one follow-up session three months after completing the intervention to repeat the evaluation

Behavioral: Placebo Inhibitory control training

Interventions

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, 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, or lose 1 point. 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 (active)

Inhibitory control training

Placebo 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, Rossi et al., 2009). Images 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, or lose 1 point. Participants must respond as quickly and accurately as possible. Here, three separate categories of non-food items (stationery, flowers and clothing) would be Go signal (associated with green 100%), No-Go signal (associated with red 100%) and control (50% red 50% green) respectively.

Also known as: FoodT (placebo)

Placebo inhibitory control training

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
• Internet access
• Computer and smartphone

You may not qualify if:

• Traumatic, digestive, metabolic or systemic disorders that affect the central nervous system, autonomic or endocrine
• Severe psychopathological disorders, moderate depressive symptoms or treatment for depression
• Eating disorders

Sponsors & Collaborators

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

Study Sites (1)

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

Granada, Spain

RECRUITING

Related Links

• Project website

MeSH Terms

Conditions

Overweight; Obesity; Inhibition, Psychological

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

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)