Inhibitory Control Training for Excess Weight: Behavioural, Cognitive and Anthropometric Changes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorRaquel Vilar López
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
BMI between 25 and 39.9
Age between 18 and 60 years
Proficiency in the Spanish language
Internet access
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Inhibitory control training
BehavioralComputerized 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
Placebo Inhibitory control training
BehavioralComputerized 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.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Inhibitory control trainingExperimental treatment 1 intervention
Group B: Placebo inhibitory control trainingPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)Secondary outcomes
1
Food Craving. Mean change from baseline at post-intervention
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
Time frame
Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)2
Waist circumference (WC). Mean change from baseline at post-intervention
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.
Time frame
Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)]3
Waist-to-hip ratio (WHR). Mean change from baseline at post-intervention
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).
Time frame
Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)]4
Waist-to-height ratio (WHtR). Mean change from baseline at post-intervention
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.
Time frame
Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)]Other outcomes
1
Descriptive measures
A socio-demographic questionnaire will be administered to examine age, education, gender, socio-economic variables and clinical variables to consider exclusion and inclusion criteria. All these variables are qualitative.
Time frame
Pre-treatment assessment (week 2)2
Depression Symptoms . Screening
The Beck Depression Inventory (BDI-II) will also be used to rule out major depressive symptoms as an exclusion criteria. The scores range from 0 to 63 points. Participants with a score higher than 29, indicative of severe symptoms, will be excluded.
Time frame
Pre-treatment assessment (week 2)3
Anxiety Symptoms . Screening
The anxiety subscale of the DASS-21 will also be used to rule out symptoms of major anxiety as an exclusion criterion. The scores for both subscales range from 0 to 21. Participants with a score higher than 8, indicative of severe symptoms, will be excluded from the study.
Time frame
Pre-treatment assessment (week 2)4
Eating and Weight Patterns. Screening
Questionnaire on Eating and Weight Patterns-5 (QEWP-5) is adapted to DSM-5 criteria and will be used to exclude people with binge eating problems and bulimia. The QEWP-5 is not scored on a traditional numerical scale like other psychological tests; instead, responses are used to identify the presence of eating disorder symptoms. Positive responses to key questions about the frequency of binge eating, compensatory behaviors, and emotional distress may indicate the presence of an eating disorder.
Time frame
Pre-treatment assessment (week 2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Raquel Vilar López
Lead sponsor
Universidad de Granada
Sponsor institution
Government of Spain
Collaborator
Source ClinicalTrials.gov