NCT02045628

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
212

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 2, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

December 2, 2013

Last Update Submit

March 1, 2016

Conditions

Obesity

Keywords

Bariatric SurgeryHealth Psychology

Outcome Measures

Primary Outcomes (1)

  • Change in weight

    Excess weight loss at 12 months after bariatric surgery.

    12 months follow up.

Secondary Outcomes (1)

  • Change in psychological outcomes

    12 month follow up

Study Arms (2)

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).

Behavioral: Investment intervention

Control

NO INTERVENTION

Those in the control group will receive usual care.

Interventions

Investment interventionBEHAVIORAL

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).

Investment intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Hospital

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 26217533DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological 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 2, 2013

First Posted

January 27, 2014

Study Start

November 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 2, 2016

Record last verified: 2016-03

Locations

GB(1)