The Impact of a Bariatric Rehabilitation Service on Patient Outcomes

NCT01264120 | Unknown

• 1 other identifier: PB-PG-0909-20178 NIHR
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Bariatric Surgery Candidate

Keywords

Obesity; Bariatric surgery; Health Psychology

Outcome Measures

Primary Outcomes (1)

• Change in weight and BMI

  The weight and height of patients will be obtained to determine BMI change over the duration of the intervention.

  Baseline, 3, 6 and 12 months

Secondary Outcomes (2)

• Change in psychological measures

  Baseline, 3,6 and 12 months.

• Cost-effectiveness

  At the end of the intervention

Study Arms (2)

Health Psychology Intervention

EXPERIMENTAL

A 50 minute health psychology behavioural intervention with sessions pre-surgery, post-surgery and at 3 month follow up.

Behavioral: Health Psychology Intervention

Control Group

NO INTERVENTION

The control group receive usual care through the bariatric surgery process.

Interventions

Health Psychology Intervention BEHAVIORAL

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.

Also known as: Bariatric rehabilitation

Health Psychology Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Surrey: lead
• Western Sussex Hospitals NHS Trust: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

St Richards Hospital

Chichester, West Sussex, PO19 6SE, United Kingdom

Location

Related Publications (2)

• Hollywood A, Ogden J, Pring C. The impact of a bariatric rehabilitation service on weight loss and psychological adjustment--study protocol. BMC Public Health. 2012 Apr 5;12:275. doi: 10.1186/1471-2458-12-275.

  PMID: 22480247 BACKGROUND

• Ogden J, Hollywood A, Pring C. The impact of psychological support on weight loss post weight loss surgery: a randomised control trial. Obes Surg. 2015 Mar;25(3):500-5. doi: 10.1007/s11695-014-1428-2.

  PMID: 25200170 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jane Ogden, PhD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 21, 2010
• Study Start: September 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

GB (1)