NCT04178486

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 20, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 27, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

October 27, 2019

Last Update Submit

November 25, 2019

Conditions

OverweightObesity

Keywords

OverweightObesityWeight lossHypnosisEating BehaviorFree Will

Outcome Measures

Primary Outcomes (1)

  • 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.

    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).

Study Arms (4)

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.

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.

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.

Behavioral: Hypnosis with memory substitution suggestions

Control

PLACEBO COMPARATOR

Hypnosis formed from only hypnotic induction (an adapted version from Barber Suggestibility Scale).

Behavioral: Hypnosis with induction only

Interventions

Hypnosis with amnesia suggestionsBEHAVIORAL

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

Amnesia
Hypnosis with cognitive rehearsal suggestionsBEHAVIORAL

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

Cognitive Rehearsal
Hypnosis with memory substitution suggestionsBEHAVIORAL

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

Memory Substitution
Hypnosis with induction onlyBEHAVIORAL

Participants received only hypnotic induction.

Control

Eligibility Criteria

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

You may qualify if:

  • Both gender Healthy Adults who want to change their eating behavior

You may not qualify if:

  • Severe mental illness \<18 years A diagnosed eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Psychology and Psychotherapy

Cluj-Napoca, Cluj, 400015, Romania

Location

Related Publications (13)

  • 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

  • Jamieson 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.

    PMID: 30042839BACKGROUND

  • Gravitz, Melvin A.

    BACKGROUND

  • 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

  • Obhi, Sukhvinder S., and Patrick Haggard.

    BACKGROUND

  • 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.

    PMID: 19072994BACKGROUND

  • Wolpert DM, Ghahramani Z, Jordan MI. An internal model for sensorimotor integration. Science. 1995 Sep 29;269(5232):1880-2. doi: 10.1126/science.7569931.

    PMID: 7569931BACKGROUND

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

    PMID: 19020512BACKGROUND

  • Libet, Benjamin.

    BACKGROUND

  • 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.

    PMID: 22195022BACKGROUND

  • Mendelsohn 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.

    PMID: 18184572BACKGROUND

  • Oakley 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.

    PMID: 23860312BACKGROUND

  • Stoeckel 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.

    PMID: 18413289BACKGROUND

MeSH Terms

Conditions

OverweightObesityWeight LossFeeding Behavior

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Loana T Comsa, Phd Student

    Babes Bolyay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants were not informed in which group they are.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomized in one of the four groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 27, 2019

First Posted

November 26, 2019

Study Start

May 20, 2019

Primary Completion

September 17, 2019

Study Completion

September 17, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)