Hypnosis and States of Change to Promote Weight Loss

NCT ID: NCT04247568

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-04
• Study Completion Date: 2022-12-30

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.

Conditions

Obesity; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hypnosis

Group Type: EXPERIMENTAL

Listening to an audiotape

Intervention Type: OTHER

The participants listen to a audiofile that consists of hypnosis

Control

Group Type: PLACEBO_COMPARATOR

Listening to an audiotape

Intervention Type: OTHER

The participants listen to a audiofile that consists of hypnosis

Interventions

Listening to an audiotape

The participants listen to a audiofile that consists of hypnosis

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jumana Antoun

Associate Professor of Clinical Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jumana Antoun

Hamra, Beyrouth, Lebanon

Countries

Lebanon

References

Antoun J, El Zouki M, Saadeh M. The use of audio self-hypnosis to promote weight loss using the transtheoretical model of change: a randomized clinical pilot trial. PeerJ. 2022 Dec 14;10:e14422. doi: 10.7717/peerj.14422. eCollection 2022.

Reference Type: DERIVED

PMID: 36536625 (View on PubMed)

Other Identifiers

SBS-2019-0220

Identifier Type: -

Identifier Source: org_study_id