- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04247568
Hypnosis and States of Change to Promote Weight Loss
The Use of Audiotaped Hypnosis in Promoting Weight Loss Using the Transtheoretical Model of Change
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beyrouth
-
Hamra, Beyrouth, Lebanon, 110236
- Jumana Antoun
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
|
The participants listen to a audiofile that consists of hypnosis
|
Experimental: Hypnosis
|
The participants listen to a audiofile that consists of hypnosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
21 days, 3 months, 6 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
21 days, 3 months, 6 months and 12 months
|
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
|
21 days, 3 months, 6 months and 12 months
|
Change 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
|
6 and 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBS-2019-0220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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