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Changing Eating Behavior Using Cognitive Training

Primary Purpose

Obesity, Overweight, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Hypnosis
Food inhibition training
Control
Sponsored by
Babes-Bolyai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Weight loss, Hypnosis, Food Inhibition Training, Go No Go Task

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Clinical Psychology and Psychotherapy
  • Departement of Clinical Psychology and and Psychotherapy, Babes-Bolyai University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Hypnosis

Food Inhibition Training

Control

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

Change in Weight
Weight in kg
Change in Eating behaviour 1 - Daily Snacking
A self reported questionnaire of high calorie food frequency
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)
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
June 22, 2020
Last Updated
August 22, 2022
Sponsor
Babes-Bolyai University
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1. Study Identification

Unique Protocol Identification Number
NCT04450524
Brief Title
Changing Eating Behavior Using Cognitive Training
Official Title
Changing Eating Behavior Using Cognitive Training: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Babes-Bolyai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Weight Loss
Keywords
Obesity, Overweight, Weight loss, Hypnosis, Food Inhibition Training, Go No Go Task

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participants will not know in which group they belong: intervention or control.
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Food Inhibition Training
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Food inhibition training
Other Intervention Name(s)
Food response inhibition training
Intervention Description
Training the associations between foods and motor inhibition using a GO-NO-GO computer task.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
A simple GO-NO-GO task
Primary Outcome Measure Information:
Title
Change in Weight
Description
Weight in kg
Time Frame
Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
Title
Change in Eating behaviour 1 - Daily Snacking
Description
A self reported questionnaire of high calorie food frequency
Time Frame
Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
Title
Change in Eating behaviour 2 - Quantity of calories intake
Description
A self reported diary of food in two different day of the week (weekday and weekend day)
Time Frame
Baseline, pre-intervention; in the week of the intervention; 1 month; 6 month.
Title
Change in Eating behaviour 3
Description
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.
Time Frame
Baseline, pre-intervention; immediately after the intervention;1 month; 6 month.
Secondary Outcome Measure Information:
Title
Change in Positive and Negative Affect
Description
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.
Time Frame
Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention;1 month; 6 month.
Title
Change in Motivation
Description
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.
Time Frame
Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
Title
Change in Self-Efficacy
Description
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.
Time Frame
Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
Title
Change in Eating Intentions
Description
Self-report - A three-point Likert scale created by authors. Higher scores indicate a stronger desire to eat high-calorie food.
Time Frame
Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
Title
Change in Eating Preferences
Description
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.
Time Frame
Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
Other Pre-specified Outcome Measures:
Title
Behavioral Activation
Description
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.
Time Frame
Baseline, pre-intervention.
Title
Specific to food irrationality
Description
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.
Time Frame
Baseline, pre-intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loana T Comsa, Phd Student
Organizational Affiliation
Babes-Bolyai University Cluj-Napoca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Psychology and Psychotherapy
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Departement of Clinical Psychology and and Psychotherapy, Babes-Bolyai University
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
40015
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No
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Changing Eating Behavior Using Cognitive Training

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