NCT04450524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

June 22, 2020

Last Update Submit

August 22, 2022

Conditions

Keywords

ObesityOverweightWeight lossHypnosisFood Inhibition TrainingGo No Go Task

Outcome Measures

Primary Outcomes (4)

  • Change in Weight

    Weight in kg

    Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.

  • 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.

  • 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.

  • 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 Outcomes (5)

  • Change in Positive and Negative Affect

    Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention;1 month; 6 month.

  • Change in Motivation

    Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.

  • Change in Self-Efficacy

    Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.

  • Change in Eating Intentions

    Baseline, pre-intervention; during the intervention (after 2 days), immediately after the intervention; 1 month; 6 month.

  • Change in Eating Preferences

    Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.

Other Outcomes (2)

  • Behavioral Activation

    Baseline, pre-intervention.

  • Specific to food irrationality

    Baseline, pre-intervention.

Study Arms (3)

Hypnosis

EXPERIMENTAL

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

Food Inhibition Training

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

HypnosisBEHAVIORAL

Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.

Hypnosis

Training the associations between foods and motor inhibition using a GO-NO-GO computer task.

Also known as: Food response inhibition training
Food Inhibition Training
ControlBEHAVIORAL

A simple GO-NO-GO task

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Clinical Psychology and Psychotherapy

Cluj-Napoca, Cluj, 400015, Romania

Location

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

Cluj-Napoca, Cluj, 40015, Romania

Location

Related 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.

    PMID: 27838443BACKGROUND
  • 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.

    PMID: 15336254BACKGROUND
  • Haggard P. Human volition: towards a neuroscience of will. Nat Rev Neurosci. 2008 Dec;9(12):934-46. doi: 10.1038/nrn2497.

    PMID: 19020512BACKGROUND
  • 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.

    PMID: 21185896BACKGROUND
  • 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.

    PMID: 25596041BACKGROUND
  • 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.

    PMID: 28546010BACKGROUND
  • 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.

    PMID: 9265803BACKGROUND
  • 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.

    PMID: 26122756BACKGROUND
  • 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.

    PMID: 19428287BACKGROUND
  • Shallice T. Dual functions of consciousness. Psychol Rev. 1972 Sep;79(5):383-93. doi: 10.1037/h0033135. No abstract available.

    PMID: 5076868BACKGROUND
  • 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.

    PMID: 27498406BACKGROUND
  • 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.

    PMID: 15454347BACKGROUND
  • 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.

    PMID: 29098749BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 28271453BACKGROUND
  • 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

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

    BACKGROUND

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Loana T Comsa, Phd Student

    Babes-Bolyai University Cluj-Napoca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants will not know in which group they belong: intervention or control.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 29, 2020

Study Start

August 15, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations