Trial Information

The Impact of a Bariatric Rehabilitation Service on Weight Loss and Psychological Adjustment.

Design: The study will involve a trial (open randomised parallel group control trial) with
patients allocated to receive either usual care or the bariatric rehabilitation service
(BRS) pre and post bariatric (obesity) surgery. Follow up measures will be recorded at 3, 6
and 12 months post-surgery at routine follow-up clinics. In addition, qualitative interviews
will be carried out with 20 participants from both arms of the trial (BRS n=10; usual care
n=10).

Piloting: The contents of the bariatric service and the follow up measures are based on
pilot work. This pilot work has already been completed exploring what bariatric patients
want and why bariatric surgery either fails or succeeds from the patients' perspective.
Furthermore, pilot research has explored the impact of bariatric surgery on changes in mood,
cognitions and eating behaviours. The quantitative measures and qualitative responses
derived from these studies will form the basis of the intervention and the measures for the
present study.

Sample: St Richard's Hospital in Chichester, West Sussex offers a NHS based bariatric
service for obese patients with a BMI over 40 (or 35 with serious co morbidities). This is
the largest centre in the UK, with 600 patients per year receiving a bariatric operation at
this clinic (70% being a primary bypass and 20% bands (the remaining 10% are revisions)).
Patients will be recruited if they have been approved for surgery and had their date set for
their operation. The consultant surgeon, Mr Chris Pring is a collaborator on this proposal.

Procedure: Ethical approval will be in place before the start of the project. In the week
before their operation patients attend the bariatric clinic for routine tests. When patients
are sent their appointment letters they will be sent the information sheet along with it to
give them approximately 2 weeks to think about whether they would like to take part. At the
appointment patients will see the researcher who will explain the trial, obtain consent and
randomly allocate the patient to either the usual care condition or the bariatric
rehabilitation service (BRS) condition.

Randomisation: All patients who fulfil the inclusion criteria will be approached by the
researcher, asked to read an information sheet and if interested offered a written consent
form. Once a patient is consented the researcher will contact the clinical trial unit at
Surrey University who will provide third party blinded randomization to either the BRS or
usual care.

Timeline: The study will take 34 months. New patients will be recruited over a 12 month
period and followed up for 12 months postoperatively. The first 6 months will involve
preparation, setting up procedures for data collection and training the health psychologist.
The next 25 months will involve rolling out the intervention, recruitment, randomly
allocating patients to the 2 conditions, providing the BRS and collecting data on the
evaluation of service. At 18 months the 20 interviews will take place and be transcribed.
The final 3 months will be spent analyzing the data, assessing cost-effectiveness,
disseminating the results to patients and health professionals and writing up findings for
publication.