Managing weight in obese patients before heart surgery to see if this improves the effects of surgery
| ISRCTN | ISRCTN16012660 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16012660 |
| IRAS number | 201185 |
| Secondary identifying numbers | IRAS 201185, CPMS 48053, Grant Codes: PG/20/10/34886 |
- Submission date
- 23/04/2021
- Registration date
- 06/05/2021
- Last edited
- 23/05/2025
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Managing weight in obese patients before heart surgery to see if this improves the effects of surgery. The main outcomes of the trial are how often patients attend the weight management sessions and whether they lose any weight. We will also use behavioural analyses to understand how to explain the rationale for the trial to participants so that they feel confident that trusting this decision to chance is sensible.
Who can participate?
Adult patients (over 17 years) referred for cardiovascular surgery, who have obesity and willingness and ability to commit to up to 12 weekly sessions of the weight loss programme or to commit to maintaining a stable weight.
What does the study involve?
Patients who are suitable will provide their consent to take part in the trial and will be randomly allocated in a 1:1 ratio to:
Weight Management (Intervention): up to 12 weeks of a weight management programme.
Weight Stability (Control): Advised to maintain current diet and a stable weight.
What are the possible benefits and risks of participating?
There is no strong evidence for losing weight or not before your operation to help improve your recovery. This uncertainty is why currently some people are advised to lose weight, whilst others are not. This means that whichever group you are in, you will be experiencing what is already the standard of care offered, and the risks and benefits of taking part in this trial are therefore the same as if you did not take part.
Where is the study run from?
University of Leicester (UK)
When is the study starting and how long is it expected to run for?
June 2018 to May 2025
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
Hardeep Aujla (Research Manager), ha200@le.ac.uk
Contact information
Scientific
Research Manager
Department of Cardiovascular Sciences
Clinical Sciences Wing
Glenfield General Hospital
Leicester
LE3 9QP
United Kingdom
 ORCID ID |
0000-0002-5823-848X |
|---|---|
| Phone | +44 (0)116 252 2183 |
| ha200@le.ac.uk |
Scientific
University of Leicester
Department of Cardiovascular Sciences
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| ORCID ID |
0000-0003-0976-1482 |
|---|---|
| Phone | +44 (0)1162583054 |
| gjm19@le.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Pre-operative weight management to improve outcomes of cardiac surgery in adults with obesity (SLIM-CARD): a multicentre feasibility RCT |
| Study acronym | SLIM-CARD (V1.0) |
| Study objectives | 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 |
| Ethics approval(s) | Approved 11/02/2021, North West - Preston Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44(0)207 1048008; preston.rec@hra.nhs.uk), ref: 21/EM/0015 |
| Health condition(s) or problem(s) studied | Pre-operative weight management to improve outcomes of cardiac surgery in adults with obesity |
| Intervention | MONTHS 1 - 4 (approx.) ALL SITES BEHAVIOURAL STUDY 1: This will involve interviewing patients and healthcare professionals about their thoughts around cardiac surgery and recruitment into a trial involving weight management so that a 'recruitment script' can be developed. Patients: Patients will be posted a PIL ahead of their initial clinic. This will be bundled with their clinic appointment letter. When they arrive at the clinic, after their consultation with the cardiac surgeon, they will meet a research nurse who will discuss the PIL, and ask if the patient wishes to consent. If yes, then the research nurse will obtain written consent and the patients contact details on a 'Contact Slip'; sharing these with the behavioural researcher who will call the patient at a convenient time (but within 24-48 hours of the clinic appointment) and conduct the interview over the telephone and audio record it. The 'Contact Slip' will be destroyed when it is no longer needed so as not to retain personal information unnecessarily. HCPs: The process will be the same as above with the local research nurse providing the PIL to HCPs and obtaining consent at least 24 hours later. MONTHS 5 - 6 (approx.) GLENFIELD GENERAL HOSPITAL ONLY BEHAVIOURAL STUDY 2 & MAIN TRIAL: This will test the 'recruitment script'; research nurses will use it during the initial discussion with participants and this will be audio recorded and qualitatively analysed. The Clinical Trial will also commence, with patients being randomised to a weight management programme (Slimming World) or weight stability. The local research nurse will complete a referral form for the patient with their trial ID and they take this home with them. The patient then calls the Slimming World number on the form, provides their trial ID to redeem the free sessions, and books onto an available and convenient session. Patients: The above procedures in Behavioural Study 1 will be followed, except that the initial discussion with a researcher will be audio recorded with verbal consent. Subsequently written consent will be sought to keep this if the participant wishes to participate in the trial. If not, and the patient is not happy for the recording to be kept, it will be deleted. Participants will otherwise have their baseline data collected immediately after written consent. Shortly thereafter, likely 1 day later, they will be telephoned by the behavioural researcher who will conduct an audio recorded interview. 2-4 weeks after the baseline visit, a researcher will telephone the patient for another audio recorded discussion concerning randomisation adherence and adverse event monitoring. One day pre-surgery, when the participant is admitted, the research team will collect the next set of data which includes body weight and a second EQ-5D questionnaire which is administered in-person. Adverse events will also be monitored here. On the day of the surgery, operative details will be recorded. Four days after the surgery, data on organ injury, infection or any other adverse events will be collected from the medical records. Six weeks after the surgery, participants will be invited to attend a routine follow-up clinic. The research team will meet with the participant to collect data on healthcare resource use since their operation, and monitor adverse events. If this cannot be done in person for any reason, the participant will be telephoned to discuss the information required. Three months after the surgery, a final telephone call will be made to collect the last set of data which includes a final EQ-5D questionnaire, healthcare resource use since their last follow-up, and monitoring any adverse events. HCPs: The above procedures in Behavioural Study 1 will be followed, except that HCPs will be initially provided with a Consent Form along with the PIL by the local research nurse. If they wish to participate, they will sign the Consent Form and post this back to the researcher who will then countersign and conduct the audio recorded interview over the telephone. MONTHS 9 - 21 ALL SITES BEHAVIOURAL STUDY 3 & MAIN TRIAL: Continues as above, except there is no recruitment of HCPs, and the interview of patients one day after baseline by the behavioural researcher is omitted. The initial discussion around the trial and consent is still audio recorded and qualitatively analysed to explore communication of equipoise and any issues hindering recruitment. The 'recruitment script' is still used. Patients are randomised as above and attend Slimming World sessions if allocated to this arm. |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility outcomes: 1. Number of participants randomised to the intervention arm attending ≥75% sessions measured using case report forms at 1-day pre-op 2. Number of participants randomised to the control arm whose weight at surgery remains within 1.5kg of their baseline weight (measured as below point 3) at 1-day pre-op Efficacy outcome: 3. Weight (kg) baseline and 1-day pre-op measured using weighing scales |
| Secondary outcome measures | 1. Recruitment rate, attrition rate, data completeness at end of study measured using case report forms 2. A composite endpoint of ischaemic organ injury: low cardiac output, acute kidney, brain or gut injury at day 5 post op measured using clinical observation and blood tests 3. A composite endpoint of infection: surgical site infection, lower respiratory tract infection, urinary tract infection, sepsis at day 5 post op measured using clinical observation and blood tests 4. Adverse events, including mortality, collected from randomisation to 3 months post-surgery at day 5 post op, 6 weeks and 3 months using case report forms 5. Quality of life measured at baseline, 1-day pre-operation and 3 months using the EQ-5D-5L 6. Resource use up to 3 months post-surgery estimated from a bespoke questionnaire at 5 post op, 6 weeks and 3 months |
| Overall study start date | 28/06/2018 |
| Completion date | 11/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 17 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 174; UK Sample Size: 174 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Adult patients (>17 years) referred for cardiovascular surgery. 2. Patients who have obesity; defined as BMI≥30 for patients of White-European ethnicity and as BMI≥27.5 for all other ethnic groups. 3. Willingness and ability to commit to up to 12 weekly sessions of the intervention or to commit to weight stability. 4. Behavioural Study 1: Willingness to be interviewed within 24-48 hours of the clinic appointment and have the interview audio recorded. |
| Key exclusion criteria | 1. Patients undergoing urgent or emergency surgery. 2. Patients who are participating in another interventional trial. 3. Patients who are currently/ recently (<3m) enrolled in a weight management programme. |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 30/11/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Cambridge Biomedical Campus
Cambridge
CB2 0AY
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Liverpool
L14 3PE
United Kingdom
Sponsor information
University/education
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 (0)1162584099 |
|---|---|
| rgosponsor@le.ac.uk | |
| Website | http://www.le.ac.uk/ |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 27/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V2.0 | 03/02/2021 | 06/05/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN16012660_Protocol_V2.0_03Feb2021.docx
- uploaded 06/05/2021
Editorial Notes
23/05/2025: The researchers terminated this study early on 11/03/2025. The main barriers were:
1. Pre-habilitation services are only available in 4/37 (13%) UK cardiac centres. Most centres had no fixed point in the pre-surgery patient pathway for the delivery of the intervention. Significant heterogeneity in pre-surgery waiting times between centres and unplanned cancellations of up to 30% of elective surgeries created further barriers to the timing of the intervention.
2. The effects of the COVID-19 pandemic on research delivery capacity.
25/11/2024: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The overall end date was changed from 28/02/2025 to 31/05/2025.
15/09/2023: The following changes have been made:
1. The recruitment end date was changed from 30/09/2023 to 30/11/2024
2. The overall study end date was changed from 31/12/2023 to 28/02/2025.
3. The intention to publish date was changed from 31/12/2024 to 27/02/2026.
30/06/2023: A study contact was updated.
19/06/2023: The following changes have been made to the study record:
1. The recruitment end date was changed from 01/06/2023 to 30/09/2023.
2. The overall study end date was changed from 01/12/2023 to 31/12/2023.
23/12/2021: The recruitment start date was changed from 01/12/2021 to 01/01/2022.
23/11/2021: The recruitment start date was changed from 01/11/2021 to 01/12/2021.
18/10/2021: The recruitment start date has been changed from 01/10/2021 to 01/11/2021.
27/07/2021: The recruitment start date has been changed from 01/07/2021 to 01/10/2021.
15/06/2021: The recruitment start date was changed from 01/06/2021 to 01/07/2021.
07/05/2021: Internal review.
06/05/2021: Uploaded protocol (not peer-reviewed) as an additional file. Version 2.0, 3 February 2021.
23/04/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
