The Impact of a Bariatric Rehabilitation Service on Patient Outcomes

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Western Sussex Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Surrey
ClinicalTrials.gov Identifier:
NCT01264120
First received: December 16, 2010
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

Obesity is a major health problem that is affecting more and more people's lives. One of the most successful treatments for obesity is weight loss surgery. Not all patients, however, lose the desired amount of weight, some regain weight and some have the surgery reversed. Interviews with patients and discussions with patient support groups indicate that many of the 'unsuccessful' patients feel unprepared for the operation and describe how although the surgery fixes their body it neglects their mind. They would therefore like to have more psychological support.

The present study aims to set up and evaluate a health psychology led bariatric rehabilitation service (BRS) and determine the impact of such a service on patient outcomes following surgery. The BRS would offer information, support and mentoring pre and post surgery and address psychological issues such as dietary control, self esteem, coping and emotional eating. It is predicted that a bariatric rehabilitation service would primarily improve weight loss following surgery but would also aid changes in other aspects of the patient's well being.

Obesity is a risk factor for a multitude of illnesses such as heart disease, diabetes and cancer. If effective, obesity surgery improves a patient's health and reduces their need for NHS care. If unsuccessful then the costs include not only subsequent NHS costs due to these other illnesses but also the costs of the unsuccessful operation and the emotional cost to the patient. The bariatric rehabilitation service should help to improve the effectiveness of surgery which in the longer term is likely to be cost effective.

This research is a direct response to the needs identified by patients and by offering a more comprehensive bariatric service the success and subsequent health and well being of obese patients should be improved.


Condition Intervention
Obesity
Bariatric Surgery Candidate
Behavioral: Health Psychology Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Impact of a Bariatric Rehabilitation Service on Weight Loss and Psychological Adjustment.

Resource links provided by NLM:


Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • Change in weight and BMI [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    The weight and height of patients will be obtained to determine BMI change over the duration of the intervention.


Secondary Outcome Measures:
  • Change in psychological measures [ Time Frame: Baseline, 3,6 and 12 months. ] [ Designated as safety issue: No ]
    The secondary outcome measure is the impact of the BRS on patients' quality of life, dietary control, coping strategies and emotional eating.

  • Cost-effectiveness [ Time Frame: At the end of the intervention ] [ Designated as safety issue: No ]
    The cost-effectiveness of the intervention will be calculated.


Estimated Enrollment: 290
Study Start Date: September 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health Psychology Intervention
A 50 minute health psychology behavioural intervention with sessions pre-surgery, post-surgery and at 3 month follow up.
Behavioral: Health Psychology Intervention
The health psychology intervention will involve a bariatric rehabilitation service (BRS) which will involve those allocated to the intervention receiving usual care plus three 50 minute sessions with a health psychologist pre-operatively (1 week before surgery), perioperatively (before they are discharged from hospital) and at 3 month follow up.
Other Name: Bariatric rehabilitation
No Intervention: Control Group
The control group receive usual care through the bariatric surgery process.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • if they consent
  • aged 18 or over
  • have attended the bariatric clinic at Chichester
  • been accepted for surgery
  • have funding in place for surgery (i.e. their primary care trust has agreed to pay for their surgery).

Exclusion Criteria:

  • those who do not wish to take part in the randomisation
  • those who do not wish to take part in the intervention
  • those who will not be having bariatric surgery because they are not a suitable patient
  • those who will not be having bariatric surgery because they can not secure funding from their primary care trust for the surgery
  • those who cannot effectively read or speak English, as this would pose a difficulty in implementing the intervention and for data collection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264120

Locations
United Kingdom
St Richards Hospital
Chichester, West Sussex, United Kingdom, PO19 6SE
Sponsors and Collaborators
University of Surrey
Western Sussex Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Jane Ogden, PhD University of Surrey
  More Information

Publications:
Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT01264120     History of Changes
Other Study ID Numbers: PB-PG-0909-20178 NIHR
Study First Received: December 16, 2010
Last Updated: January 23, 2014
Health Authority: United Kingdom: National Institute for Health Research

Keywords provided by University of Surrey:
Obesity
Bariatric surgery
Health Psychology

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014