None listed
Conditions
Brief summary
This pilot study will investigate the feasibility of implementing a multidisciplinary pre-operative very low calorie (VLCD) weight loss program in adult obese patients awaiting general elective surgery. This study will initially enrol a pilot sample of 50 patients who have a Body mass Index (BMI) equal to or over 30kg/m2 who attend the Pre-admission clinic for elective general surgery at The Prince Charles Hospital. Participants will be randomised into a control group or an intervention group. Participants in the intervention group will follow an 8 week very low calorie diet that incorporates Optifast meal replacement shakes. Participants randomised to the control group will receive standard care that includes a generic weight loss information pack provided by the clinic nurse. Measures to assess health related quality of life, body composition and adherence to the program will be collected. Unfavourable surgical outcomes will be measured until 30 days post elective surgery.
Interventions
The intervention is an 8 week Very Low Calorie Diet weight loss program that utlises Optifast meal replacement shakes to 700-800calories/ day intake. This will be achieved through the daily oral consumption of 3-4 Optifast products (shakes) with an additional 2 cups (non-starch) salad, at least 2 litres of calorie free fluids, and 1 teaspoon of oil.
Processes established to measure fidelity / adherence to treatment protocols will be implemented which may include but not limited to urinary ketone
The intervention is an 8 week Very Low Calorie Diet weight loss program that utlises Optifast meal replacement shakes to 700-800calories/ day intake. This will be achieved through the daily oral consumption of 3-4 Optifast products (shakes) with an additional 2 cups (non-starch) salad, at least 2 litres of calorie free fluids, and 1 teaspoon of oil. Processes established to measure fidelity / adherence to treatment protocols will be implemented which may include but not limited to urinary ketones. Urinary ketones will be collected by the clinic nurse.
Sponsors
Department of Surgery and Department of Nutrition and Dietetics, The Prince Charles Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Elective general surgical patients at The Prince Charles Hospital BMI >30kgm2 >18 years old eGFR >60ml/min/1.73m2
Exclusion criteria
Pregnant, preparing undergoing IVF Cirrhosis, liver failure, portal hypertension Acute cardiovascular disease Type 1 Diabetes Mellitus Use lithium long-term use of corticosteroids (> 2 weeks duration) People with an intellectual or mental impairment
Outcome results
None listed