ObesityNCT01264120
The Impact of a Bariatric Rehabilitation Service on Patient Outcomes
A study testing Health Psychology Intervention in people with Obesity and Bariatric Surgery Candidate, run by University of Surrey at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate
- What is being tested?
- Health Psychology Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Richards Hospital
Chichester, West Sussex, PO19 6SE
About this study
Official title: The Impact of a Bariatric Rehabilitation Service on Weight Loss and Psychological Adjustment.
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.
Read more
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.
Read the 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.
- Conditions
- Obesity, Bariatric Surgery Candidate
- Being tested
- Health Psychology Intervention
- Keywords
- Obesity, Bariatric surgery, Health Psychology
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Psychology InterventionBehavioural
Also called Bariatric rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Psychology Intervention | Experimental | A 50 minute health psychology behavioural intervention with sessions pre-surgery, post-surgery and at 3 month follow up. Receives: Behavioral: Health Psychology Intervention |
| Control Group | No intervention | The control group receive usual care through the bariatric surgery process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight and BMI
The weight and height of patients will be obtained to determine BMI change over the duration of the intervention.
Measured: Baseline, 3, 6 and 12 months
Secondary outcomes (2)
Change in psychological measures
The secondary outcome measure is the impact of the BRS on patients' quality of life, dietary control, coping strategies and emotional eating.
Measured: Baseline, 3,6 and 12 months.
Cost-effectiveness
The cost-effectiveness of the intervention will be calculated.
Measured: At the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startSep 2011
- Primary completionJan 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Western Sussex Hospitals NHS Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Jane Ogden, PhD, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264120
- Sponsor's protocol ID
- PB-PG-0909-20178 NIHR
- Status last verified
- Jan 2014
- First submitted
- 16 Dec 2010
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22480247Ogden 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.
PubMed 25200170
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Bariatric Rehabilitation Service on Weight Loss and Psychological Adjustment.
- ClinicalTrials.gov ID
- NCT01264120
- Acronym / sponsor ID
- PB-PG-0909-20178 NIHR
- Conditions
- Obesity, Bariatric Surgery Candidate
- Keywords
- Obesity, Bariatric surgery, Health Psychology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Western Sussex Hospitals NHS Trust, National Institute for Health Research, United Kingdom
- Study start
- Sep 2011
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Psychology Intervention | Experimental | Behavioral: Health Psychology InterventionA 50 minute health psychology behavioural intervention with sessions pre-surgery, post-surgery and at 3 month follow up. |
| Control Group | No intervention | –The control group receive usual care through the bariatric surgery process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Psychology InterventionAlso: Bariatric rehabilitationThe 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. | Behavioural | Health Psychology Intervention |
Primary outcome
Change in weight and BMI
Time frame: Baseline, 3, 6 and 12 months
The weight and height of patients will be obtained to determine BMI change over the duration of the intervention.
2 secondary outcomes
Change in psychological measures
Time frame: Baseline, 3,6 and 12 months.
Cost-effectiveness
Time frame: At the end of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
- Background: PubMed 22480247Hollywood 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.
- Derived from this study: PubMed 25200170Ogden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Ogden, PhD principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Psychology Intervention in people with Obesity and Bariatric Surgery Candidate, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight and BMI (time frame: Baseline, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01264120, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.