Changing Eating Behavior Using Cognitive Training

Obesity Clinical Trial

Official title:

Changing Eating Behavior Using Cognitive Training: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450524
• Other study ID #: Phd Study 4
• Status: Completed
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: August 2022
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Hypnosis
Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.
• Food inhibition training
Training the associations between foods and motor inhibition using a GO-NO-GO computer task.
• Control
A simple GO-NO-GO task

Locations

Country	Name	City	State
Romania	Departement of Clinical Psychology and and Psychotherapy, Babes-Bolyai University	Cluj-Napoca	Cluj
Romania	Department of Clinical Psychology and Psychotherapy	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

References & Publications (18)

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. — View Citation

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. — View Citation

Haggard P, Cartledge P, Dafydd M, Oakley DA. Anomalous control: when 'free-will' is not conscious. Conscious Cogn. 2004 Sep;13(3):646-54. — View Citation

Haggard P. Human volition: towards a neuroscience of will. Nat Rev Neurosci. 2008 Dec;9(12):934-46. doi: 10.1038/nrn2497. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

Kirsch I, Lynn SJ. Hypnotic involuntariness and the automaticity of everyday life. Am J Clin Hypn. 1997 Jul;40(1):329-48. Review. — View Citation

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. — View Citation

Norman, D. A., & Shallice, T. (1986). Attention to action. In Consciousness and self-regulation (pp. 1-18). Springer, Boston, MA.

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. Review. — View Citation

Shallice T. Dual functions of consciousness. Psychol Rev. 1972 Sep;79(5):383-93. — View Citation

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. Review. — View Citation

Strack F, Deutsch R. Reflective and impulsive determinants of social behavior. Pers Soc Psychol Rev. 2004;8(3):220-47. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Behavioral Activation	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.
Other	Specific to food irrationality	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.
Primary	Change in Weight	Weight in kg	Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
Primary	Change in Eating behaviour 1 - Daily Snacking	A self reported questionnaire of high calorie food frequency	Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
Primary	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)	Baseline, pre-intervention; in the week of the intervention; 1 month; 6 month.
Primary	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.	Baseline, pre-intervention; immediately after the intervention;1 month; 6 month.
Secondary	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.	Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention;1 month; 6 month.
Secondary	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.	Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
Secondary	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.	Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
Secondary	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.	Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
Secondary	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.	Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.