Clinical trial NCT04450524: Changing Eating Behavior Using Cognitive Training
Official title: Changing Eating Behavior Using Cognitive Training: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Weight Loss
Keywords: Obesity
Overweight
Weight loss
Hypnosis
Food Inhibition Training
Go No Go Task
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
measure: Change in Eating behaviour 1 - Daily Snacking
timeFrame: Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
measure: Change in Eating behaviour 2 - Quantity of calories intake
timeFrame: Baseline, pre-intervention; in the week of the intervention; 1 month; 6 month.
measure: Change in Eating behaviour 3
timeFrame: Baseline, pre-intervention; immediately after the intervention;1 month; 6 month.
Secondary outcomes:
measure: Change in Positive and Negative Affect
timeFrame: Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention;1 month; 6 month.
measure: Change in Motivation
timeFrame: Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
measure: Change in Self-Efficacy
timeFrame: Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
measure: Change in Eating Intentions
timeFrame: Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.
measure: Change in Eating Preferences
timeFrame: Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.
Other outcomes:
measure: Behavioral Activation
timeFrame: Baseline, pre-intervention.
measure: Specific to food irrationality
timeFrame: Baseline, pre-intervention.
Locations:
city: Cluj-Napoca
country: Romania
facility: Department of Clinical Psychology and Psychotherapy
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Departement of Clinical Psychology and and Psychotherapy, Babes-Bolyai University
state: Cluj
Study officials:
affiliation: Babes-Bolyai University Cluj-Napoca
name: Loana T Comsa, Phd Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/j.concog.2004.06.001.
citation: Haggard P. Human volition: towards a neuroscience of will. Nat Rev Neurosci. 2008 Dec;9(12):934-46. doi: 10.1038/nrn2497.
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.
citation: 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.
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.
citation: 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.
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.
citation: 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.
citation: Shallice T. Dual functions of consciousness. Psychol Rev. 1972 Sep;79(5):383-93. doi: 10.1037/h0033135. No abstract available.
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.
citation: 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.
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.
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
citation: 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
citation: 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.
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
citation: Norman, D. A., & Shallice, T. (1986). Attention to action. In Consciousness and self-regulation (pp. 1-18). Springer, Boston, MA.