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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN69640604
Date of registration: 16/03/2012
Prospective Registration: Yes
Primary sponsor: University of Hull (UK)
Public title: Study to investigate weight loss using ?virtual gastric band? hypnotherapy compared to ?relaxation? hypnotherapy and following a self directed diet.
Scientific title: A pilot study to investigate weight loss using ?virtual gastric band? hypnotherapy compared to ?relaxation? hypnotherapy and following a self directed diet.
Date of first enrolment: 13/03/2012
Target sample size: 30
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN69640604
Study type:  Interventional
Study design:  Randomised open labelled parallel trial (Treatment)  
Phase:  Not Applicable
Countries of recruitment
United Kingdom
Contacts
Name:  
Address: 
Telephone:
Email:
Affiliation: 
Name: Stephen  Atkin
Address:  Head of Academic Diabetes Endocrinology & Metabolism Michael White Diabetes Centre Hull Royal Infirmary Anlaby Road HU3 2RW Hull United Kingdom
Telephone: +44 (0)1482 675312
Email: stephen.atkin@hyms.ac.uk
Affiliation: 
Key inclusion & exclusion criteria
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

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


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Overweight and obesity
Nutritional, Metabolic, Endocrine
Obesity
Intervention(s)
?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.
Primary Outcome(s)
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(s)
No secondary outcome measures
Secondary ID(s)
N/A
Source(s) of Monetary Support
University of Hull (UK) - HONEI Project
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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