Hypnosis and States of Change to Promote Weight Loss
Primary Purpose
Obesity, Weight Loss
Status
Unknown status
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Listening to an audiotape
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Weight loss, Hypnosis, Adults, Behavior change
Eligibility 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.
Sites / Locations
- Jumana Antoun
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hypnosis
Control
Arm Description
Outcomes
Primary Outcome Measures
Acquiring at least one stage change (upward) as defined by the S-weight
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
Weight change
difference in the weight between hypnosis audio-file and control audio-file, at 3 weeks, 6 and 12 months as compared to baseline weight
difference in the mean score of any item of the processes of change
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
Change in waist circumference in cm as compared to baseline
decrease in waist circumference in cm as compared to baseline
Full Information
NCT ID
NCT04247568
First Posted
January 28, 2020
Last Updated
July 20, 2021
Sponsor
American University of Beirut Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04247568
Brief Title
Hypnosis and States of Change to Promote Weight Loss
Official Title
The Use of Audiotaped Hypnosis in Promoting Weight Loss Using the Transtheoretical Model of Change
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Weight loss, Hypnosis, Adults, Behavior change
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypnosis
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Listening to an audiotape
Intervention Description
The participants listen to a audiofile that consists of hypnosis
Primary Outcome Measure Information:
Title
Acquiring at least one stage change (upward) as defined by the S-weight
Description
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.
Time Frame
21 days, 3 months, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Weight change
Description
difference in the weight between hypnosis audio-file and control audio-file, at 3 weeks, 6 and 12 months as compared to baseline weight
Time Frame
21 days, 3 months, 6 months and 12 months
Title
difference in the mean score of any item of the processes of change
Description
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
Time Frame
21 days, 3 months, 6 months and 12 months
Title
Change in waist circumference in cm as compared to baseline
Description
decrease in waist circumference in cm as compared to baseline
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Jumana Antoun
City
Hamra
State/Province
Beyrouth
ZIP/Postal Code
110236
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
No
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Hypnosis and States of Change to Promote Weight Loss
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