SLIM-CARD (V1.0)
Research type
Research Study
Full title
Pre-operative weight management to improve outcomes of cardiac surgery in adults with obesity (SLIM-CARD): a multicentre feasibility RCT
IRAS ID
286239
Contact name
Gavin Murphy
Contact email
Sponsor organisation
University of Leicester
ISRCTN Number
ISRCTN16012660
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
We think that patients who are obese will recover better after their heart operation if they lose weight beforehand. In order to achieve this, we are collaborating with Slimming World to provide patients with the opportunity to attend up to 12 weekly sessions of weight management prior to their operation.
The trial will test the hypothesis that a weight management programme will achieve satisfactory levels of adherence, acceptability of randomisation to this weight management programme, and clinically important weight loss while the control group participants stay the same weight. We will ask Slimming World to share weight and attendance records with us to address these aims.
We will also conduct qualitative interviews to explore behavioural aspects of the trial. This will help us initially to understand patients' and healthcare professionals' thoughts and feelings about cardiac surgery and weight management so that we can develop a 'recruitment script'. We can then test this script in a single site, again conducting interviews to explore how effective it is and re-iterate as needed before rolling out to all recruiting sites. We will audio record discussions around recruitment and consent to explore the communication of equipoise and any issues around recruitment.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0015
Date of REC Opinion
11 Feb 2021
REC opinion
Further Information Favourable Opinion