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Completed

NCT Number: NCT04450524

Changing Eating Behavior Using Cognitive Training

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypnosis

Behavioral

Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.

Food inhibition training

Behavioral

Training the associations between foods and motor inhibition using a GO-NO-GO computer task.

Other names: Food response inhibition training

Control

Behavioral

A simple GO-NO-GO task

Primary outcomes

  1. Change in Weight

    Time frame: Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.

    Weight in kg

  2. Change in Eating behaviour 1 - Daily Snacking

    Time frame: Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.

    A self reported questionnaire of high calorie food frequency

  3. Change in Eating behaviour 2 - Quantity of calories intake

    Time frame: 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)

  4. Change in Eating behaviour 3

    Time frame: 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 outcomes

  1. Change in Positive and Negative Affect

    Time frame: 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.

  2. Change in Motivation

    Time frame: 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.

  3. Change in Self-Efficacy

    Time frame: 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.

  4. Change in Eating Intentions

    Time frame: 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.

  5. Change in Eating Preferences

    Time frame: 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.

Other outcomes

  1. Behavioral Activation

    Time frame: Baseline, pre-intervention.

    The Fun Seeking Subscale from the Behavioral Inhibition/Behavioral Activation Scales with 4 self-rated items using a 4-point Likert scale (1=very true for me, to 4=very false for me). Higher scores are linked to impulsivity.

  2. Specific to food irrationality

    Time frame: Baseline, pre-intervention.

    Self report - Irrational Food Beliefs Scale. The responses are made using Likert type ratings from 1 - strongly disagree to 4 strongly agree. Highest scores are significantly associated with weight gain and poor weight loss maintenance.

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Official study title

Changing Eating Behavior Using Cognitive Training: A Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2020
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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