Pre-operative weight management to improve outcomes of cardiac surgery in adults with obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
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 invo
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 r
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 rando
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed