- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04450524
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
135
Phase
- 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
-
-
Cluj
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Cluj-Napoca, Cluj, Romania, 400015
- Department of Clinical Psychology and Psychotherapy
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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
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 |
Intervention / Treatment |
---|---|
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.
|
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).
|
Training the associations between foods and motor inhibition using a GO-NO-GO computer task.
Other Names:
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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.
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A simple GO-NO-GO task
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What is the study measuring?
Primary Outcome Measures
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.
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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
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Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
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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)
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Baseline, pre-intervention; in the week of the intervention; 1 month; 6 month.
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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
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.
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Change in Motivation
Time Frame: Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
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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.
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Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
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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.
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Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
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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.
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Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
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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
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.
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Baseline, pre-intervention.
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Specific to food irrationality
Time Frame: Baseline, pre-intervention.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
- Adams RC, Lawrence NS, Verbruggen F, Chambers CD. Training response inhibition to reduce food consumption: Mechanisms, stimulus specificity and appropriate training protocols. Appetite. 2017 Feb 1;109:11-23. doi: 10.1016/j.appet.2016.11.014. Epub 2016 Nov 9.
- Haggard P, Cartledge P, Dafydd M, Oakley DA. Anomalous control: when 'free-will' is not conscious. Conscious Cogn. 2004 Sep;13(3):646-54. doi: 10.1016/j.concog.2004.06.001.
- Haggard P. Human volition: towards a neuroscience of will. Nat Rev Neurosci. 2008 Dec;9(12):934-46. doi: 10.1038/nrn2497.
- Houben K, Jansen A. Training inhibitory control. A recipe for resisting sweet temptations. Appetite. 2011 Apr;56(2):345-9. doi: 10.1016/j.appet.2010.12.017. Epub 2010 Dec 24.
- Houben K, Jansen A. Chocolate equals stop. Chocolate-specific inhibition training reduces chocolate intake and go associations with chocolate. Appetite. 2015 Apr;87:318-23. doi: 10.1016/j.appet.2015.01.005. Epub 2015 Jan 13.
- Jones A, Hardman CA, Lawrence N, Field M. Cognitive training as a potential treatment for overweight and obesity: A critical review of the evidence. Appetite. 2018 May 1;124:50-67. doi: 10.1016/j.appet.2017.05.032. Epub 2017 May 22.
- Kirsch I, Lynn SJ. Hypnotic involuntariness and the automaticity of everyday life. Am J Clin Hypn. 1997 Jul;40(1):329-48. doi: 10.1080/00029157.1997.10403402.
- Lawrence NS, O'Sullivan J, Parslow D, Javaid M, Adams RC, Chambers CD, Kos K, Verbruggen F. Training response inhibition to food is associated with weight loss and reduced energy intake. Appetite. 2015 Dec;95:17-28. doi: 10.1016/j.appet.2015.06.009. Epub 2015 Jun 29.
- Oakley DA, Halligan PW. Hypnotic suggestion and cognitive neuroscience. Trends Cogn Sci. 2009 Jun;13(6):264-70. doi: 10.1016/j.tics.2009.03.004. Epub 2009 May 8.
- Shallice T. Dual functions of consciousness. Psychol Rev. 1972 Sep;79(5):383-93. doi: 10.1037/h0033135. No abstract available.
- Stice E, Lawrence NS, Kemps E, Veling H. Training motor responses to food: A novel treatment for obesity targeting implicit processes. Clin Psychol Rev. 2016 Nov;49:16-27. doi: 10.1016/j.cpr.2016.06.005. Epub 2016 Jul 21.
- Strack F, Deutsch R. Reflective and impulsive determinants of social behavior. Pers Soc Psychol Rev. 2004;8(3):220-47. doi: 10.1207/s15327957pspr0803_1.
- Turton R, Nazar BP, Burgess EE, Lawrence NS, Cardi V, Treasure J, Hirsch CR. To Go or Not to Go: A Proof of Concept Study Testing Food-Specific Inhibition Training for Women with Eating and Weight Disorders. Eur Eat Disord Rev. 2018 Jan;26(1):11-21. doi: 10.1002/erv.2566. Epub 2017 Nov 3.
- Beck, I., Smits, D. J., Claes, L., Vandereycken, W., & Bijttebier, P. (2009). Psychometric evaluation of the behavioral inhibition/behavioral activation system scales and the sensitivity to punishment and sensitivity to reward questionnaire in a sample of eating disordered patients. Personality and Individual Differences, 47(5), 407-412
- Carver, C. S., & White, T. L. (1994). Behavioral inhibition, behavioral activation, and affective responses to impending reward and punishment: the BIS/BAS scales. Journal of personality and social psychology, 67(2), 319
- Giel KE, Speer E, Schag K, Leehr EJ, Zipfel S. Effects of a food-specific inhibition training in individuals with binge eating disorder-findings from a randomized controlled proof-of-concept study. Eat Weight Disord. 2017 Jun;22(2):345-351. doi: 10.1007/s40519-017-0371-3. Epub 2017 Mar 7.
- Hofmann, W., Friese, M., & Wiers, R. W. (2008). Impulsive versus reflective influences on health behavior: A theoretical framework and empirical review. Health Psychology Review, 2(2), 111-137
- Norman, D. A., & Shallice, T. (1986). Attention to action. In Consciousness and self-regulation (pp. 1-18). Springer, Boston, MA.
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)
August 15, 2020
Primary Completion (Actual)
January 31, 2021
Study Completion (Actual)
January 31, 2021
Study Registration Dates
First Submitted
June 22, 2020
First Submitted That Met QC Criteria
June 26, 2020
First Posted (Actual)
June 29, 2020
Study Record Updates
Last Update Posted (Actual)
August 23, 2022
Last Update Submitted That Met QC Criteria
August 22, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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