None listed
Conditions
Brief summary
This study aims to compare usual care with a remotely delivered, dietitian led very low calorie diet (VLCD) program to assess whether pre surgery weight loss is safe and acceptable for patients with excess weight awaiting colorectal cancer surgery. Who is it for? You may be eligible for this study if you are aged 18 or over, with a body mass index (BMI) of 28kg/m² or above, and scheduled for elective colorectal cancer surgery. Study details All eligible participants will take part in a multicentre, two arm randomised controlled trial conducted across Metro South Health facilities. Participants will be randomly assigned to one of two groups: usual care (no weight loss intervention before surgery) or participation in a remotely delivered, dietitian led very low calorie diet clinic prior to surgery. Participants allocated to the intervention group will follow an individualised VLCD at home, supported by weekly dietitian appointments delivered via telehealth (video or phone). The diet uses meal replacement products alongside selected vegetables and fluids and is tailored to individual needs. Dietitians will provide education, monitor adherence, and offer ongoing support until surgery, with additional contact by SMS or email if required. Participants in the usual care group will proceed to surgery without a pre operative weight loss program. After completion of the intervention, participants will be assessed for adverse events, physical function and surgical outcomes. It is hoped this research will inform clinical practice by clarifying whether a remotely delivered VLCD program is a safe and acceptable pre operative approach for people with excess weight undergoing colorectal cancer surgery, helping guide future care decisions and improve surgical outcomes.
Interventions
The basis of the intervention is a dietitian-led very low calorie diet (VLCD) program. A Very Low Calorie Diet utilises meal replacement products (Optifast or Optislim) providing ~800kcal/day and will be individualised through dietitian-led treatment. The VLCD will include the oral consumption of 1-4 meal replacement products, with an additional 2 cups of non-starchy vegetables and at least 2 litres of non-caffeinated, calorie-free fluids. Dependent on lifestyle factors, age, and ability to adhe
The basis of the intervention is a dietitian-led very low calorie diet (VLCD) program. A Very Low Calorie Diet utilises meal replacement products (Optifast or Optislim) providing ~800kcal/day and will be individualised through dietitian-led treatment. The VLCD will include the oral consumption of 1-4 meal replacement products, with an additional 2 cups of non-starchy vegetables and at least 2 litres of non-caffeinated, calorie-free fluids. Dependent on lifestyle factors, age, and ability to adhere to the diet, participants will be recommended to consume variations of the described VLCD, utilising 1-4 meal replacement products, and specific portions of allowed foods. At the initial dietitian appointment (60mins), education about the VLCD-based prescription will be delivered. Participants will attend weekly dietitian appointments until surgery. At review appointments (20-30 mins), the aim is to check adherence to the prescription (and provide recommendations to adjust as needed), maintain motivation during the adjustment to meal replacements, and problem-solve issues that arise. In addition to the weekly dietitian reviews, other methods of remote or digital interaction may be initiated by the participant to the dietitian, such as SMS or email. Adherence to the intervention will be assessed using diet histories taken weekly by dietitian at review appointments. Participants will also be asked questions to measure adherence within the intervention participant survey which will be administered on surgery day or as close to surgery day as possible. The dietitian appointments will be administered via telehealth (video or phone calls) and the participants will be asked to follow the diet at home while undertaking their usual life. They will not be admitted to hospital for administration of the intervention. The VLCD program will be delivered between 30 days and 14 days prior to surgery, depending on the participants scheduled surgery date. Durations will be recorded.
Sponsors
Metro South Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults Planned for elective curative CRC resection BMI of 28kg/m2 or above Completed neoadjuvant (e.g. chemotherapy / radiation) treatment (if indicated). At least 14 days until surgery (at least 14 days on VLCD required to facilitate meaningful weight loss and liver volume reduction)
Exclusion criteria
Unintentional loss of 10% or more body weight in last 6 months Taking warfarin ASA Physical Status IV Already attending VLCD Clinic care outside of the trial Radiological suspicion of imminent intestinal obstruction or endoscopic evidence of an impassable tumour Pregnancy, breastfeeding, or planning pregnancy during the course of the trial Any other significant disease or disorder which may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. Currently taking part in other interventional clinical trials unless agreed in advance by all trial teams (participation in observational studies is allowed)
Outcome results
None listed