Changing Eating Behavior Using Cognitive Training

Not Applicable

Completed

• Conditions: Weight Loss; Obesity; Overweight

• Registration Number: NCT04450524
• Lead Sponsor: Babes-Bolyai University

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.

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-06-29
• Study Start: 2020-08-15
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Eating behaviour 2 - Quantity of calories intake	Baseline, pre-intervention; in the week of the intervention; 1 month; 6 month.	A self reported diary of food in two different day of the week (weekday and weekend day)
Change in Weight	Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.	Weight in kg
Change in Eating behaviour 1 - Daily Snacking	Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.	A self reported questionnaire of high calorie food frequency
Change in Eating behaviour 3	Baseline, pre-intervention; immediately after the intervention;1 month; 6 month.	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.

Secondary Outcome Measures

Name	Time	Method
Change in Self-Efficacy	Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.	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.
Change in Motivation	Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.	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.
Change in Eating Preferences	Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.	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.
Change in Eating Intentions	Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.	Self-report - A three-point Likert scale created by authors. Higher scores indicate a stronger desire to eat high-calorie food.
Change in Positive and Negative Affect	Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention;1 month; 6 month.	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.

Trial Locations

Locations (2)

Department of Clinical Psychology and Psychotherapy; 🇷🇴 Cluj-Napoca, Cluj, Romania

Departement of Clinical Psychology and and Psychotherapy, Babes-Bolyai University; 🇷🇴 Cluj-Napoca, Cluj, Romania