Changing Eating Behavior Using Cognitive Training

August 22, 2022 updated by: Comsa Loana, Babes-Bolyai University

Changing Eating Behavior Using Cognitive Training: A Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Department of Clinical Psychology and Psychotherapy
      • Cluj-Napoca, Cluj, Romania, 40015
        • Departement of Clinical Psychology and and Psychotherapy, Babes-Bolyai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hypnosis
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
Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.
Experimental: Food Inhibition Training
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
Training the associations between foods and motor inhibition using a GO-NO-GO computer task.
Other Names:
  • Food response inhibition training
Placebo Comparator: Control
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
A simple GO-NO-GO task

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Weight
Time Frame: Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
Weight in kg
Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
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
Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
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)
Baseline, pre-intervention; in the week of the intervention; 1 month; 6 month.
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.
Baseline, pre-intervention; immediately after the intervention;1 month; 6 month.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention;1 month; 6 month.
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.
Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
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.
Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
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.
Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
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.
Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, pre-intervention.
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.
Baseline, pre-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Babes-Bolyai University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Loana T Comsa, Phd Student, Babes-Bolyai University Cluj-Napoca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Phd Study 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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