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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02045628
• Other study ID #: PB-PG-0212-27034
• Status: Active, not recruiting
• Phase: N/A
• First received: December 2, 2013
• Last updated: March 1, 2016
• Start date: November 2013
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health ResearchUnited Kingdom: National Health Service
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 212
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Investment intervention
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).

Locations

Country	Name	City	State
United Kingdom	University College Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
University of Surrey	University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Excess weight loss at 12 months after bariatric surgery.	12 months follow up.	No
Secondary	Change in psychological outcomes	Psychological issues relating to beliefs about food, intentions to change diet and exercise and actual diet and exercise behaviours.	12 month follow up	No