ObesityNCT02045628
The Impact of an Investment Based Intervention on Weight-loss and Beliefs About Food in Patients Post Bariatric Surgery
A study testing Investment intervention in people with Obesity, run by University of Surrey at 1 site in United Kingdom.
Trial summary
Although obesity surgery is currently the most effective method for achieving weight loss, not all patients lose the desired amount of weight and some show weight regain. Previous pilot work by the lead researcher shows that successful weight loss is associated with the amount of investment the patient feels that they… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Investment intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Mar 2016
- 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
- aged 18 or over
- having bariatric surgery at University College Hospital
Who cannot join
- if the patient does not understand English
- if the patient does not consent to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of an Investment Based Intervention on Weight-loss and Beliefs About Food in Patients Post Bariatric Surgery.
Although obesity surgery is currently the most effective method for achieving weight loss, not all patients lose the desired amount of weight and some show weight regain. Previous pilot work by the lead researcher shows that successful weight loss is associated with the amount of investment the patient feels that they have made in their operation. For example, those who feel that it has taken more time and effort to organise, has cost more money, has been more disruptive to their family, social and work lives and has caused pain are more likely to lose weight after their operation. Therefore, it seems as if the greater the sense of investment, the greater the motivation to make the operation a success. The present study aims to build on these findings by encouraging weight loss surgery patients to focus on the investment they have made, thus making their investment more salient to them. Using a trial design, half the patients will be asked to rate and describe the investment they have made in their operation just before surgery (focusing on the time and effort to organise the surgery etc) and 3 months after surgery (focusing on time off work for recovery, disruption of family and friends, pain of surgery, pain of having the stitches removed etc). All patients will record their weight, beliefs about food, intentions to change their behaviour and actual eating and exercise behaviour at baseline then 3, 6 and 12 months follow up. The impact of the investment based intervention will then be assessed to explore whether focusing on the investment involved in having surgery improves patient health outcomes by one year.
- Conditions
- Obesity
- Being tested
- Investment intervention
- Keywords
- 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.
Investment interventionBehavioural
Those in the investment group will complete carefully framed questions designed to raise the salience of the investment they have made in their procedure at baseline and 3 months follow up. The content of this intervention will be tailored to the recent experiences of the patient (ie pre or post surgery).
| Study group | Role | What they receive |
|---|---|---|
| Investment intervention | Experimental | Those in the investment group will complete carefully framed questions designed to raise the salience of the investment they have made in their procedure at baseline and 3 months follow up. The content of this intervention will be tailored to the recent experiences of the patient (ie pre or post surgery). Receives: Behavioral: Investment intervention |
| Control | No intervention | Those in the control group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Excess weight loss at 12 months after bariatric surgery.
Measured: 12 months follow up.
Secondary outcomes (1)
Change in psychological outcomes
Psychological issues relating to beliefs about food, intentions to change diet and exercise and actual diet and exercise behaviours.
Measured: 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Jane Ogden, PhD, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045628
- Sponsor's protocol ID
- PB-PG-0212-27034
- Status last verified
- Mar 2016
- First submitted
- 2 Dec 2013
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hollywood A, Ogden J, Hashemi M. A randomised control trial assessing the impact of an investment based intervention on weight-loss, beliefs and behaviour after bariatric surgery: study protocol. BMC Obes. 2015 Mar 21;2:18. doi: 10.1186/s40608-015-0048-2. eCollection 2015.
PubMed 26217533
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Investment Based Intervention on Weight-loss and Beliefs About Food in Patients Post Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT02045628
- Acronym / sponsor ID
- PB-PG-0212-27034
- Conditions
- Obesity
- Keywords
- Bariatric Surgery, Health Psychology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- Nov 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 27 Jan 2014 (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.
Although obesity surgery is currently the most effective method for achieving weight loss, not all patients lose the desired amount of weight and some show weight regain. Previous pilot work by the lead researcher shows that successful weight loss is associated with the amount of investment the patient feels that they have made in their operation. For example, those who feel that it has taken more time and effort to organise, has cost more money, has been more disruptive to their family, social and work lives and has caused pain are more likely to lose weight after their operation. Therefore, it seems as if the greater the sense of investment, the greater the motivation to make the operation a success. The present study aims to build on these findings by encouraging weight loss surgery patients to focus on the investment they have made, thus making their investment more salient to them. Using a trial design, half the patients will be asked to rate and describe the investment they have made in their operation just before surgery (focusing on the time and effort to organise the surgery etc) and 3 months after surgery (focusing on time off work for recovery, disruption of family and friends, pain of surgery, pain of having the stitches removed etc). All patients will record their weight, beliefs about food, intentions to change their behaviour and actual eating and exercise behaviour at baseline then 3, 6 and 12 months follow up. The impact of the investment based intervention will then be assessed to explore whether focusing on the investment involved in having surgery improves patient health outcomes by one year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investment intervention | Experimental | Behavioral: Investment interventionThose in the investment group will complete carefully framed questions designed to raise the salience of the investment they have made in their procedure at baseline and 3 months follow up. The content of this intervention will be tailored to the recent experiences of the patient (ie pre or post surgery). |
| Control | No intervention | –Those in the control group will receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18 or over
- having bariatric surgery at University College Hospital
Key exclusion criteria (2 listed)
- if the patient does not understand English
- if the patient does not consent to take part in the study
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 |
|---|---|---|
| Investment interventionThose in the investment group will complete carefully framed questions designed to raise the salience of the investment they have made in their procedure at baseline and 3 months follow up. The content of this intervention will be tailored to the recent experiences of the patient (ie pre or post surgery). | Behavioural | Investment intervention |
Primary outcome
Change in weight
Time frame: 12 months follow up.
Excess weight loss at 12 months after bariatric surgery.
1 secondary outcome
Change in psychological outcomes
Time frame: 12 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Derived from this study: PubMed 26217533Hollywood A, Ogden J, Hashemi M. A randomised control trial assessing the impact of an investment based intervention on weight-loss, beliefs and behaviour after bariatric surgery: study protocol. BMC Obes. 2015 Mar 21;2:18. doi: 10.1186/s40608-015-0048-2. eCollection 2015.
- Individual participant dataSharing planned: Undecided
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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 Investment intervention in people with Obesity, 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 2 inclusion and 2 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 2 Mar 2016. 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 (time frame: 12 months follow up.). 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 NCT02045628, which also lists 1 linked publication.
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 2 Mar 2016.