Changing Eating Behavior Using Cognitive Training

Study Overview
=================
Brief Summary
-----------------
Obesity is a global health problem. New and more efficient interventions are needed to overcome this disease. This randomized clinical trial aims to evaluate the effectiveness of changing eating behavior using cognitive training. These types of interventions have the role of creating new routines (unconsciously processed), in terms of healthy eating behaviors.

Detailed Description
-----------------
This is a randomized clinical trial with three groups. Participants will be found through social media announcements. The active interventions of cognitive training will be delivered at two groups: one group will receive through hypnosis and the other will receive through food inhibition training (a GO NO GO task). The control group will receive a simple GO NO GO task as an active placebo. The trial will be exclusively online and it consists of five sessions. Participants will complete their tasks on four Zoom sessions. Cognitive, emotional and behavioral data will be taken at four times: before the intervention starts, in the middle (after two sessions), at the end and at two follow up moments: one month and six months after the trial ends.

Official Title
-----------------
Changing Eating Behavior Using Cognitive Training: A Randomized Clinical Trial

Conditions
-----------------
Obesity, Overweight, Weight Loss

Intervention / Treatment
-----------------
* Behavioral: Hypnosis
* Behavioral: Food inhibition training
* Behavioral: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Persons who like high-calorie foods (self-report food preferences) Persons who have a medium to high score at the self-report daily snacking BMI>25 Exclusion Criteria: Enrolled in a weight loss program Under 18 years Health problems that can affect weight loss Persons with clinical problems such as diabetes, cardiovascular disease, mental problems, persons who take medicines that can affect weight loss

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis<br>Hypnosis formed from hypnotic induction (an adapted version from Harvard Group Scale of Hypnotic Susceptibility) together with hypnotic suggestions about a future where they will control their eating behaviors by choosing the low-calorie food instead of dense calorie one. | Behavioral: Hypnosis<br>* Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.<br>|
| Experimental: Food Inhibition Training<br>Participants will perform an online computer go-no-go task. They will be shown pictures of dense and low-calorie food together with neutral pictures, followed by the instruction to press or not a button when the pictures are framed in a bold frame (dense calorie food). | Behavioral: Food inhibition training<br>* Training the associations between foods and motor inhibition using a GO-NO-GO computer task.<br>* Other names: Food response inhibition training;|
| Placebo Comparator: Control<br>Participants will perform an online computer go-no-go task. They will be shown pictures of dense and low-calorie food together with neutral pictures, followed by the instruction to press the button to indicate the position of the picture - left or right. | Behavioral: Control<br>* A simple GO-NO-GO task<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Weight in kg | Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month. | 
| Change in Eating behaviour 1 - Daily Snacking | A self reported questionnaire of high calorie food frequency | Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month. | 
| Change in Eating behaviour 2 - Quantity of calories intake | A self reported diary of food in two different day of the week (weekday and weekend day) | Baseline, pre-intervention; in the week of the intervention; 1 month; 6 month. | 
| Change in Eating behaviour 3 | Self-reported Three Factor Eating Questionnaire. The scale measures three aspects of eating behavior: cognitive restraint (CR), uncontrolled eating (UE), and emotional eating (EE). It has 21 items and the responses are on a four-point Likert scale ranging from 1 Definitely true to 4 Definitely false with three subscales one for each domain. Higher scores indicate greater CR, UE, or EE. | Baseline, pre-intervention; immediately after the intervention;1 month; 6 month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Positive and Negative Affect | Self-report - Positive and Negative Schedule (PANAS). The responses are made using Likert type ratings from 1 - Not at all, to 5 Very much. Higher scores on negative affect representing higher levels of negative affect and higher scores on positive affect representing higher levels of positive affect. | Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention;1 month; 6 month. | 
| Change in Motivation | Self-report - Intrinsic Motivation Inventory. The interest/enjoyment subscale is considered the self-report measure of intrinsic motivation; The responses are made using Likert type ratings from 1 - not at all true to 7 very true. Higher total scores indicate higher intrinsic motivation. | Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month. | 
| Change in Self-Efficacy | Self-report - Weight Efficacy Lifestyle Questionnaire. The response is given using a Likert scale in 0 to10 points: 0 for Not confident at all and 10 indicates Very confident. Higher total scores are associated with higher eating self-efficacy and motivation to make positive lifestyle changes. | Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month. | 
| Change in Eating Intentions | Self-report - A three-point Likert scale created by authors. Higher scores indicate a stronger desire to eat high-calorie food. | Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month. | 
| Change in Eating Preferences | Self-report - A three-point Likert scale created by authors about the preferences of high-calorie food. Higher scores mean a high preference for high-calorie food. | Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Overweight, Weight loss, Hypnosis, Food Inhibition Training, Go No Go Task