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The Impact of an Investment Based Intervention on Weight-loss and Beliefs About Food in Patients Post Bariatric Surgery

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Investment intervention
Sponsored by
University of Surrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Bariatric Surgery, Health Psychology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 18 or over
  • having bariatric surgery at University College Hospital

Exclusion Criteria:

  • if the patient does not understand English
  • if the patient does not consent to take part in the study

Sites / Locations

  • University College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Investment intervention

Control

Arm Description

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).

Those in the control group will receive usual care.

Outcomes

Primary Outcome Measures

Change in weight
Excess weight loss at 12 months after bariatric surgery.

Secondary Outcome Measures

Change in psychological outcomes
Psychological issues relating to beliefs about food, intentions to change diet and exercise and actual diet and exercise behaviours.

Full Information

First Posted
December 2, 2013
Last Updated
March 1, 2016
Sponsor
University of Surrey
Collaborators
University College London Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02045628
Brief Title
The Impact of an Investment Based Intervention on Weight-loss and Beliefs About Food in Patients Post Bariatric Surgery
Official Title
The Impact of an Investment Based Intervention on Weight-loss and Beliefs About Food in Patients Post Bariatric Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Surrey
Collaborators
University College London Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Bariatric Surgery, Health Psychology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investment intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Those in the control group will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Investment intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in weight
Description
Excess weight loss at 12 months after bariatric surgery.
Time Frame
12 months follow up.
Secondary Outcome Measure Information:
Title
Change in psychological outcomes
Description
Psychological issues relating to beliefs about food, intentions to change diet and exercise and actual diet and exercise behaviours.
Time Frame
12 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 18 or over having bariatric surgery at University College Hospital Exclusion Criteria: if the patient does not understand English if the patient does not consent to take part in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Ogden, PhD
Organizational Affiliation
University of Surrey
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26217533
Citation
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.
Results Reference
derived

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The Impact of an Investment Based Intervention on Weight-loss and Beliefs About Food in Patients Post Bariatric Surgery

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