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Hypnosis and States of Change to Promote Weight Loss

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ClinicalTrials.gov Identifier: NCT04247568
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Jumana Antoun, American University of Beirut Medical Center

Brief Summary:

Complementary and alternative therapies for weight loss treatment may be effective. There are few studies showing promise of the use of hypnosis in weight-reduction programs; however, there are lots of bias and more rigorous rials are needed to establish the relationship between hypnosis and weight management. Furthermore, the effect of hypnosis may not be directly related to weight loss but rather on behavioral change. On the basis of the trans theoretical model of change, we hypothesized that audio taped hypnosis would facilitate greater movement through the stages of change toward weight loss as compared to general advice.

OBJECTIVE: The primary aim of this study is to assess the ability of audio taped hypnosis to promote weight loss through its effect on the stages and the processes of change as defined by the Trans theoretical Model of change.

DESIGN: Randomized controlled trial. SETTING: American University of Beirut Medical Center. PARTICIPANTS: Adults with overweight and obesity will be recruited if they had previous attempt to lose weight, are planning to lose weight within the next 6 months or are not satisfied with the results of their current weight loss plan.

INTERVENTIONS: This research will be triple blinded randomized placebo controlled trial. The intervention group will be listening to a hypnotic audio-file on a USB and the control group will be listening to a placebo audio-file on a USB . The hypnotic audio-file will consist of a 20 minutes recording prepared by an experienced hypnotist and the control audio-file will consist of a 20 minutes recording with direct messages targeting lifestyle modification. Follow up visits will take place at 21 days, 3 months, 6 months and 12 months following the intervention to assess for any change in participant's readiness to lose weight.

MAIN OUTCOME MEASURES: The primary outcome will be the difference between the groups in acquiring at least one stage change (upward) as defined by the S-weight from baseline to 3 weeks, 6 months and 12 months post intervention. The secondary outcomes include difference in the mean score of any item of the processes of change between hypnosis audio-file and control audio-file, weight in kg at 3 weeks, 6 and 12 months as compared to baseline weight, decrease in waist circumference in cm as compared to baseline at 6 and 12 months between the hypnosis and control groups, exploring factors that may affect any of the primary and secondary outcomes such as gender, age, educational status, baseline BMI, PHQ2.


Condition or disease Intervention/treatment Phase
Obesity Other: Listening to an audiotape Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Audiotaped Hypnosis in Promoting Weight Loss Using the Transtheoretical Model of Change
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypnosis Other: Listening to an audiotape
The participants listen to a audiofile that consists of hypnosis

Placebo Comparator: Control Other: Listening to an audiotape
The participants listen to a audiofile that consists of hypnosis




Primary Outcome Measures :
  1. Acquiring at least one stage change (upward) as defined by the S-weight [ Time Frame: 21 days, 3 months, 6 months and 12 months ]
    the difference between the groups in acquiring at least one stage change (upward) as defined by the S-weight from baseline to 3 weeks, 6 months and 12 months post intervention.


Secondary Outcome Measures :
  1. Weight change [ Time Frame: 21 days, 3 months, 6 months and 12 months ]
    difference in the weight between hypnosis audio-file and control audio-file, at 3 weeks, 6 and 12 months as compared to baseline weight

  2. difference in the mean score of any item of the processes of change [ Time Frame: 21 days, 3 months, 6 months and 12 months ]
    difference in the mean score of any item of the processes of change between hypnosis audio-file and control audio-file, weight in kg at 3 weeks, 6 and 12 months as compared to baseline

  3. decrease in waist circumference in cm as compared to baseline [ Time Frame: 6 and 12 months ]
    decrease in waist circumference in cm as compared to baseline



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 25 kg/m2 and above, aged 18 to 64 years, able to give written informed consent, fluent in English, all men and women not planning on getting pregnant within the next 12 months, with previous attempts to lose weight, planning to lose weight within the next 6 months or not satisfied with the results of their current weight loss plan.

Exclusion Criteria:

  • individuals diagnosed with a psychotic disorder, currently on an antipsychotic medication, pregnant women, women planning on getting pregnant during the study period, not planning on losing weight within the next 6 months, not meeting the inclusion criteria or those who are satisfied with their weight loss progress, and illiterate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04247568


Contacts
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Contact: Jumana Antoun, MD +9613486509 ja46@aub.edu.lb

Locations
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Lebanon
Jumana Antoun Recruiting
Hamra, Beyrouth, Lebanon, 110236
Contact: Jumana Antoun    03486509    ja46@aub.edu.lb   
Sponsors and Collaborators
American University of Beirut Medical Center
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Responsible Party: Jumana Antoun, Associate Professor of Clinical Family Medicine, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT04247568    
Other Study ID Numbers: SBS-2019-0220
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jumana Antoun, American University of Beirut Medical Center:
weight loss; hypnosis; adults; behavior change
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight