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ObesityNCT04450524

Changing Eating Behavior Using Cognitive Training

A study testing Hypnosis and Food inhibition training in people with Obesity and Overweight, run by Babes-Bolyai University at 2 sites in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight, Weight Loss
What is being tested?
Hypnosis and Food inhibition training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
2 sitesRomania
Study dates
15 Aug 2020to 31 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Romania2 sites

  • Department of Clinical Psychology and Psychotherapy

    Cluj-Napoca, Cluj, 400015

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

    Cluj-Napoca, Cluj, 40015

Other trials in Romania

About this study

Official title: 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.

Read the 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.

Being tested
Hypnosis, Food inhibition training, Control
Keywords
Obesity, Overweight, Weight loss, Hypnosis, Food Inhibition Training, Go No Go Task
Medical subject headings
Obesity, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypnosisBehavioural

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

  • Food inhibition trainingBehavioural

    Also called Food response inhibition training

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

  • ControlBehavioural

    A simple GO-NO-GO task

Study groups in NCT04450524
Study groupRoleWhat they receive
HypnosisExperimentalHypnosis 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.
Receives: Behavioral: Hypnosis
Food Inhibition TrainingExperimentalParticipants 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).
Receives: Behavioral: Food inhibition training
ControlPlacebo comparatorParticipants 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.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight

    Weight in kg

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

  2. Change in Eating behaviour 1 - Daily Snacking

    A self reported questionnaire of high calorie food frequency

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

  3. 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)

    Measured: Baseline, pre-intervention; in the week of the intervention; 1 month; 6 month.

  4. 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.

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

Secondary outcomes (5)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2020
  2. Study start15 Aug 2020
  3. Primary completion31 Jan 2021
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04450524
Sponsor's protocol ID
Phd Study 4
Status last verified
Aug 2022
First submitted
22 Jun 2020
Last updated
23 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 27838443

  • 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.

    PubMed 15336254

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

    PubMed 19020512

  • 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.

    PubMed 21185896

  • 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.

    PubMed 25596041

  • 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.

    PubMed 28546010

  • 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.

    PubMed 9265803

  • 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.

    PubMed 26122756

  • 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.

    PubMed 19428287

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

    PubMed 5076868

  • 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.

    PubMed 27498406

  • 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.

    PubMed 15454347

  • 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.

    PubMed 29098749

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis and Food inhibition training in people with Obesity and Overweight, run by Babes-Bolyai University at 2 sites in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight (time frame: Baseline, pre-intervention; immediately after the intervention; 1 month; 6 month.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04450524, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.

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Changing Eating Behavior Using Cognitive Training | AzTrials