OverweightNCT04178486
Changing Eating Behaviors of Healthy Adults Through Hypnosis
A study testing Hypnosis with amnesia suggestions, Hypnosis with cognitive rehearsal suggestions and Hypnosis with memory substitution suggestions in people with Overweight and Obesity, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
There is a lot of research on weight loss. In spite of the research on the subject, obesity is a growing disease all through the world. The results of recent reviews and meta-analyzes show that psychological interventions had small effect on weight loss. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Hypnosis with amnesia suggestions, Hypnosis with cognitive rehearsal suggestions and Hypnosis with memory substitution suggestions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteRomania
- Study dates
- 20 May 2019to 17 Sep 2019
- 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
- Both gender Healthy Adults who want to change their eating behavior
Who cannot join
- Severe mental illness <18 years A diagnosed eating disorder
Trial locations and contacts
1 site in 1 country.
Romania1 site
Department of Clinical Psychology and Psychotherapy
Cluj-Napoca, Cluj, 400015
About this study
Official title: Eating Behavior - Choice or Reconstruction of Past Experience? Changing Eating Behaviors of Healthy Adults Through Hypnotic Suggestions
There is a lot of research on weight loss. In spite of the research on the subject, obesity is a growing disease all through the world. The results of recent reviews and meta-analyzes show that psychological interventions had small effect on weight loss. The investigators propose a different approach to changing eating behaviors with relevance to weight management and hypothesize that participants in the active interventions will significantly improve their eating behaviors than the ones in the control group. The results will improve the psychological interventions for weight loss.
Read the detailed description
This is a randomized clinical trial consisting of four groups. According to the concept of Free Will, the decision of action is taken before being acknowledged and is made following the reconstruction of previous experiences. It can be inhibited immediately (max 100ms) after awareness. The investigators want to intervene based on this model using hypnotic suggestions to change eating behaviors. Participants were found through social media announcements. Three groups receive one session of hypnosis with induction and different suggestions and the control group receives only induction. The eating behavior is measured through computer tasks in which participants have the option to choose pictures of food. The task is performed before, during and after hypnosis and the measurements of eating behavior are taken at all three times.
- Conditions
- Overweight, Obesity
- Being tested
- Hypnosis with amnesia suggestions, Hypnosis with cognitive rehearsal suggestions, Hypnosis with memory substitution suggestions, Hypnosis with induction only
- Keywords
- Overweight, Obesity, Weight loss, Hypnosis, Eating Behavior, Free Will
- Medical subject headings
- Overweight, Obesity, Weight Loss, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis with amnesia suggestionsBehavioural
Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.
Hypnosis with cognitive rehearsal suggestionsBehavioural
Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.
Hypnosis with memory substitution suggestionsBehavioural
Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.
Hypnosis with induction onlyBehavioural
Participants received only hypnotic induction.
| Study group | Role | What they receive |
|---|---|---|
| Amnesia | Experimental | Hypnosis formed from hypnotic induction (an adapted version from Barber Suggestibility Scale) together with hypnotic suggestions to experience amnesia for the food pictures they had just seen. Receives: Behavioral: Hypnosis with amnesia suggestions |
| Cognitive Rehearsal | Experimental | Hypnosis formed from hypnotic induction (an adapted version from Barber Suggestibility Scale) together with hypnotic suggestions about a future where they will control their eating behaviors. Receives: Behavioral: Hypnosis with cognitive rehearsal suggestions |
| Memory Substitution | Experimental | Hypnosis formed from hypnotic induction (an adapted version from Barber Suggestibility Scale) together with hypnotic suggestions about a past where they have always controlled their eating behaviors. Receives: Behavioral: Hypnosis with memory substitution suggestions |
| Control | Placebo comparator | Hypnosis formed from only hypnotic induction (an adapted version from Barber Suggestibility Scale). Receives: Behavioral: Hypnosis with induction only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eating Behavior
The number of food pictures chosen by the participant in this single session intervention. The outcome is a measure assessing a change between three time points.
Measured: The intervention is delivered in one session. The outcome is measured: immediately pre intervention (0-2 min), during intervention and immediately post intervention (0-2 min).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start20 May 2019
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Participants were randomized in one of the four groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Comsa Loana, Babes-Bolyai University
- Investigators
- Loana T Comsa, Phd Student, Principal investigator, Babes Bolyay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178486
- Sponsor's protocol ID
- Phd Study
- Status last verified
- Nov 2019
- First submitted
- 27 Oct 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 15336254Jamieson GA, Kittenis MD, Tivadar RI, Evans ID. Inhibition of retrieval in hypnotic amnesia: dissociation by upper-alpha gating. Neurosci Conscious. 2017 Apr 19;2017(1):nix005. doi: 10.1093/nc/nix005. eCollection 2017.
PubMed 30042839Gravitz, Melvin A.
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 19428287Obhi, Sukhvinder S., and Patrick Haggard.
Kuhn S, Haggard P, Brass M. Intentional inhibition: how the "veto-area" exerts control. Hum Brain Mapp. 2009 Sep;30(9):2834-43. doi: 10.1002/hbm.20711.
PubMed 19072994Wolpert DM, Ghahramani Z, Jordan MI. An internal model for sensorimotor integration. Science. 1995 Sep 29;269(5232):1880-2. doi: 10.1126/science.7569931.
PubMed 7569931Haggard P. Human volition: towards a neuroscience of will. Nat Rev Neurosci. 2008 Dec;9(12):934-46. doi: 10.1038/nrn2497.
PubMed 19020512Libet, Benjamin.
Terhune DB, Brugger P. Doing better by getting worse: posthypnotic amnesia improves random number generation. PLoS One. 2011;6(12):e29206. doi: 10.1371/journal.pone.0029206. Epub 2011 Dec 15.
PubMed 22195022Mendelsohn A, Chalamish Y, Solomonovich A, Dudai Y. Mesmerizing memories: brain substrates of episodic memory suppression in posthypnotic amnesia. Neuron. 2008 Jan 10;57(1):159-70. doi: 10.1016/j.neuron.2007.11.022.
PubMed 18184572Oakley DA, Halligan PW. Hypnotic suggestion: opportunities for cognitive neuroscience. Nat Rev Neurosci. 2013 Aug;14(8):565-76. doi: 10.1038/nrn3538. Epub 2013 Jul 17.
PubMed 23860312Stoeckel LE, Weller RE, Cook EW 3rd, Twieg DB, Knowlton RC, Cox JE. Widespread reward-system activation in obese women in response to pictures of high-calorie foods. Neuroimage. 2008 Jun;41(2):636-47. doi: 10.1016/j.neuroimage.2008.02.031. Epub 2008 Mar 4.
PubMed 18413289
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Behavior - Choice or Reconstruction of Past Experience? Changing Eating Behaviors of Healthy Adults Through Hypnotic Suggestions
- ClinicalTrials.gov ID
- NCT04178486
- Acronym / sponsor ID
- Phd Study
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Weight loss, Hypnosis, Eating Behavior, Free Will
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a lot of research on weight loss. In spite of the research on the subject, obesity is a growing disease all through the world. The results of recent reviews and meta-analyzes show that psychological interventions had small effect on weight loss. The investigators propose a different approach to changing eating behaviors with relevance to weight management and hypothesize that participants in the active interventions will significantly improve their eating behaviors than the ones in the control group. The results will improve the psychological interventions for weight loss.
Detailed description
This is a randomized clinical trial consisting of four groups. According to the concept of Free Will, the decision of action is taken before being acknowledged and is made following the reconstruction of previous experiences. It can be inhibited immediately (max 100ms) after awareness. The investigators want to intervene based on this model using hypnotic suggestions to change eating behaviors. Participants were found through social media announcements. Three groups receive one session of hypnosis with induction and different suggestions and the control group receives only induction. The eating behavior is measured through computer tasks in which participants have the option to choose pictures of food. The task is performed before, during and after hypnosis and the measurements of eating behavior are taken at all three times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants were randomized in one of the four groups.
| Arm | Type | Receives |
|---|---|---|
| Amnesia | Experimental | Behavioral: Hypnosis with amnesia suggestionsHypnosis formed from hypnotic induction (an adapted version from Barber Suggestibility Scale) together with hypnotic suggestions to experience amnesia for the food pictures they had just seen. |
| Cognitive Rehearsal | Experimental | Behavioral: Hypnosis with cognitive rehearsal suggestionsHypnosis formed from hypnotic induction (an adapted version from Barber Suggestibility Scale) together with hypnotic suggestions about a future where they will control their eating behaviors. |
| Memory Substitution | Experimental | Behavioral: Hypnosis with memory substitution suggestionsHypnosis formed from hypnotic induction (an adapted version from Barber Suggestibility Scale) together with hypnotic suggestions about a past where they have always controlled their eating behaviors. |
| Control | Placebo comparator | Behavioral: Hypnosis with induction onlyHypnosis formed from only hypnotic induction (an adapted version from Barber Suggestibility Scale). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Both gender Healthy Adults who want to change their eating behavior
Key exclusion criteria (1 listed)
- Severe mental illness <18 years A diagnosed eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosis with amnesia suggestionsParticipants received hypnotic induction with hypnotic suggestions for their eating behaviors. | Behavioural | Amnesia |
| Hypnosis with cognitive rehearsal suggestionsParticipants received hypnotic induction with hypnotic suggestions for their eating behaviors. | Behavioural | Cognitive Rehearsal |
| Hypnosis with memory substitution suggestionsParticipants received hypnotic induction with hypnotic suggestions for their eating behaviors. | Behavioural | Memory Substitution |
| Hypnosis with induction onlyParticipants received only hypnotic induction. | Behavioural | Control |
Primary outcome
Change in Eating Behavior
Time frame: The intervention is delivered in one session. The outcome is measured: immediately pre intervention (0-2 min), during intervention and immediately post intervention (0-2 min).
The number of food pictures chosen by the participant in this single session intervention. The outcome is a measure assessing a change between three time points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Background: PubMed 15336254Haggard 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.
- Background: PubMed 30042839Jamieson GA, Kittenis MD, Tivadar RI, Evans ID. Inhibition of retrieval in hypnotic amnesia: dissociation by upper-alpha gating. Neurosci Conscious. 2017 Apr 19;2017(1):nix005. doi: 10.1093/nc/nix005. eCollection 2017.
- BackgroundGravitz, Melvin A.
- Background: PubMed 19428287Oakley 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.
- BackgroundObhi, Sukhvinder S., and Patrick Haggard.
- Background: PubMed 19072994Kuhn S, Haggard P, Brass M. Intentional inhibition: how the "veto-area" exerts control. Hum Brain Mapp. 2009 Sep;30(9):2834-43. doi: 10.1002/hbm.20711.
- Background: PubMed 7569931Wolpert DM, Ghahramani Z, Jordan MI. An internal model for sensorimotor integration. Science. 1995 Sep 29;269(5232):1880-2. doi: 10.1126/science.7569931.
- Background: PubMed 19020512Haggard P. Human volition: towards a neuroscience of will. Nat Rev Neurosci. 2008 Dec;9(12):934-46. doi: 10.1038/nrn2497.
- BackgroundLibet, Benjamin.
- Background: PubMed 22195022Terhune DB, Brugger P. Doing better by getting worse: posthypnotic amnesia improves random number generation. PLoS One. 2011;6(12):e29206. doi: 10.1371/journal.pone.0029206. Epub 2011 Dec 15.
- Background: PubMed 18184572Mendelsohn A, Chalamish Y, Solomonovich A, Dudai Y. Mesmerizing memories: brain substrates of episodic memory suppression in posthypnotic amnesia. Neuron. 2008 Jan 10;57(1):159-70. doi: 10.1016/j.neuron.2007.11.022.
- Background: PubMed 23860312Oakley DA, Halligan PW. Hypnotic suggestion: opportunities for cognitive neuroscience. Nat Rev Neurosci. 2013 Aug;14(8):565-76. doi: 10.1038/nrn3538. Epub 2013 Jul 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loana T Comsa, Phd Student principal investigator
Babes Bolyay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis with amnesia suggestions, Hypnosis with cognitive rehearsal suggestions and Hypnosis with memory substitution suggestions in people with Overweight and Obesity, run by Babes-Bolyai University at 1 site 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 1 inclusion and 1 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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Eating Behavior (time frame: The intervention is delivered in one session. The outcome is measured: immediately pre intervention (0-2 min), during intervention and immediately post intervention (0-2 min).). 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 NCT04178486, which also lists 13 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 26 Nov 2019.