Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2012
Date assigned
16/03/2012
Last edited
26/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In the UK it has been reported that 1 in 4 UK adults are obese and a further about 4 in 10 of men and 3 in 10 women are overweight. Excess weight is an increasing problem both to the health of the nation and individuals who are struggling to lose weight. Scientists agree that to lose weight it is necessary to eat fewer calories than their body uses in everyday living. Unfortunately, for many people, this is difficult.Hypnotherapy is a commonly used process of hypnosis, making suggestions to a person for therapeutic (health benefits) purposes. ‘Virtual gastric band’ hypnotherapy involves mind management techniques designed to form a new set of eating habits and although reported to have a 95% success rate in helping individuals to lose weight, the treatment is not very well known and the results yet to be confirmed. This study aims to show whether the ‘virtual gastric band’ hypnotherapy technique is an effective method in helping people to lose weight. The study will be carried out by a qualified hypnotherapist and dietitian who are both experienced in supporting weight management.

Who can participate?
Participants in this study will have expressed an interest in wanting to lose weight and will have not lost more than 5% of body weight in the last 6 months. Body Mass Index (BMI) is a measurement calculated using height and weight and is good way of checking if a person is of a healthy weight. In this study participants will need to have a BMI of over 27 which indicates that they are in the overweight category. They will not have been taking any medication for any chronic condition or any medications that may cause an increase or decrease in weight [e.g. steroids, beta blockers and diuretics (water tablets)]. They will also not have any history of eating disorders and have not experienced hypnotherapy for any other condition.

What does the study involve?
Once an individual has expressed an interest in taking part in the study, a patient information sheet will be sent. At least 7 days will be allowed between receiving the patient information sheet and attending the first visit. The first visit for all participants will be at 11 Salmon Grove, University of Hull, HU6 7SX. The nature of the study will be explained in depth and a health questionnaire will be completed where any past medical history and medication will be disclosed. Height and weight will be measured. Following this, participants will be asked to give informed consent and sign the consent form. Participants will then be allocated to either the group that will receive the ‘virtual gastric band’ hypnotherapy or the group that will receive the ‘relaxation’ hypnotherapy. This allocation will be decided by a specialised computer programme. The dates for both of the group sessions will be provided at this first visit. Participants must be able to attend all sessions.
The ‘virtual gastric band’ hypnotherapy group sessions will involve a number of mind management techniques. The aim is not to get the individual to think that they have had a gastric band operation, but to help them manage portion sizes and form a new set of habits, that they can live with that enables weight loss. Guidelines are also given to the participants to follow. These guidelines are mainly around goal setting, eating three meals a day, exercise and mindful eating.
During the relaxation hypnotherapy sessions, relaxation techniques will be taught. At the first session participants will receive a booklet to aid self directed weight loss.
For both groups there will be 4 sessions (Weeks 1 to 4) that will last approximately 1 hour held at weekly intervals. There will be one further refresher session at week 8. Weight will then be taken at each session and then at weeks 16 and week 24. These two final measurements of weight will be taken at 11 Salmon Grove.

What are the possible benefits and risks of participating?
The possible benefit of taking part in this study is that an individual may lose weight. The only possible risk is that an individual may be upset if weight loss does not occur.

Where is the study run from?
All of the hypnotherapy group sessions will be held in the seminar room at the Sports Centre, University of Hull.

When is study starting and how long is it expected to run for?
The study started in March 2012 and will last for 6 months.

Who is funding the study?
The funding is provided by the Humber Obesity Nutrition Education and Innovation (HONEI) project, University of Hull.

Who is the main contact?
Claire Whitham
Claire.Whitham@hey.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Atkin

ORCID ID

Contact details

Head of Academic Diabetes
Endocrinology & Metabolism
Michael White Diabetes Centre
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2RW
United Kingdom
+44 (0)1482 675312
stephen.atkin@hyms.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A pilot study to investigate weight loss using “virtual gastric band” hypnotherapy compared to “relaxation” hypnotherapy and following a self directed diet.

Acronym

Study hypothesis

This pilot study aims to show whether the ‘virtual gastric band’ technique is a useful therapy in weight management compared to relaxation hypnotherapy and a self directed diet.

Please note that as of 14/08/2012, patient recruitment for this study is complete.

Ethics approval

Hull York Medical School Ethics Committee, 16/01/2012

Study design

Randomised open labelled parallel trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Overweight and obesity

Intervention

‘Virtual gastric band’ hypnotherapy technique

Once an individual has expressed an interest in taking part in the trial, a patient information sheet will be sent. At least 7 days will be allowed between receiving the patient information sheet and attending the first visit.

The first visit for all participants will be at the University of Hull, 11 Salmon Grove, Hull, HU6 7SX. The nature of the study will be explained in depth and a health questionnaire will be completed where any past medical history and medication will be disclosed. Height and weight will be measured. If fulfilling all of the inclusion and exclusion criteria participants will be asked to give informed consent and sign the consent form.

Participants will then be allocated to either the group that will receive the ‘virtual gastric band’ hypnotherapy or the group that will receive the ‘relaxation’ hypnotherapy. This allocation will be decided by a specialised computer programme.

The dates for both of the group sessions will be provided at this first visit. Participants must be able to attend all sessions.

The ‘virtual gastric band’ hypnotherapy group sessions will involve a number of mind management techniques. The aim is not to get the individual to think that they have had a gastric band operation, but to help them manage portion sizes and form a new set of habits, that they can live with that enables weight loss. Guidelines are also given for the client to follow. These guidelines are mainly around goal setting, eating three meals a day, exercise and mindful eating.

During the relaxation hypnotherapy sessions, relaxation techniques will be taught. At the first session participants will receive a booklet to aid self directed weight loss.
For both groups there will be 4 sessions (Weeks 1 to 4) that will last approximately 1 hour held at weekly intervals. There will be one further refresher session at week 8. Weight will then be taken at each session and then at weeks 16 and week 24.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Investigate the effect of the ‘virtual gastric band’ hypnotherapy technique on weight loss in healthy overweight adults, compared to weight loss from relaxation hypnotherapy and a self directed diet

Secondary outcome measures

No secondary outcome measures

Overall trial start date

13/03/2012

Overall trial end date

13/10/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. BMI over 27
2. Over the age of 18
3. Having obtained his/her informed assent
4. Having obtained his/her consent
5. Willing to allow their GP to be informed about their participation in the trial
6. Willing to try and lose weight

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. On any weight loss programme
2. Under medical management for being overweight or any other condition
3. Prescribed any medication for a chronic condition
4. Excessive alcohol or recreational drug use
5. Pregnancy
6. Acute illness
7. Any history of eating disorders
8. Previous experience of hypnotherapy for any purpose

Recruitment start date

13/03/2012

Recruitment end date

13/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Head of Academic Diabetes
Hull
HU3 2RW
United Kingdom

Sponsor information

Organisation

University of Hull (UK)

Sponsor details

Cottingham Road
Hull
HU6 7RX
United Kingdom
+44 (0)1482 305200
honei@hull.ac.uk

Sponsor type

University/education

Website

http://www2.hull.ac.uk/

Funders

Funder type

University/education

Funder name

University of Hull (UK) - HONEI Project

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/08/2016: No publications found, verifying study status with principal investigator