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Does preoperative dietitian-led Very Low Calorie Diet (VLCD)-based intervention reduce unfavourable elective surgery outcomes for patients with obesity?

A single-site, randomised, controlled trial to establish the impact of preoperative dietitian-led Very Low Calorie Diet (VLCD)-based intervention on unfavourable elective surgery outcomes associated with obesity.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000084886
Enrollment
144
Registered
2021-02-01
Start date
2021-06-01
Completion date
2022-03-01
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this research is to evaluate the impact of a preoperative dietitian-led VLCD intervention to determine whether the intervention reduces incidence of unfavourable surgical outcomes arising from elective, non-bariatric surgery in adults with obesity. It is hypothesised that obese adult patients who receive preoperative dietitian-led VLCD-based treatment will have shorter operating time and fewer unfavourable surgical outcomes than controls. This study will be a parallel group, two-arm, superiority randomised controlled trial with 1:1 allocation ratio. The study population will be obese adult patients on elective surgery waiting lists at Logan Hospital for a range of general, colorectal, gynaecological, and orthopaedic procedures. In absence of appropriate literature, this intervention is not being widely adopted despite likely improved surgical outcomes and cost-benefits. This research will significantly contribute to the small body of literature and likely highlight the need and allow for more widely accepted implementation of this intervention across a variety of surgery types.

Interventions

The intervention is a Very Low Calorie Diet (VLCD) which 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 co

The intervention is a Very Low Calorie Diet (VLCD) which 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. The diet will be prescribed by the dietitian at the participants' first dietitian appointment, which will be 4-12 weeks away from surgery, depending on surgery type and category (waiting times) for surgery. The participants will be asked to start the diet as soon as they can following the first dietitian appointment (where education regarding the diet will be given). Participants will attend from 2-6 dietitian appointments where they will be weighed and adherence to the diet will be monitored. The dietitian appointments will be administered via an outpatient (clinic) hospital setting, 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. To monitor adherence, a dietary adherence tool will be used to measure self-reported prescription to the diet. This diet measures how many days within the last 14 days where the diet was adhered to according to specific measures of adherence (i.e. number of products, times 'non-allowed foods' were eaten) to create an overall % adherence measure.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

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

• greater than or equal to 18 years old, no maximum age, any gender •BMI (Body Mass Index) greater than or equal to 30kg/m2 •Booked for General, Colorectal, Gynaecological, and Orthopaedic surgical procedures. Participants booked and on the waiting list for Category 2 (up to 90 days until surgery) or Category 3 (up to 365 days until surgery) procedures,

Exclusion criteria

• Type 1 Diabetes • Metastatic cancer • Liver or kidney failure • Acute cardiovascular disease • Pregnant/breastfeeding / preparing or undergoing IVF • Malnourished or Malnutrition Screening Tool (25) score >2 • Overt psychosis or severe mental impairment • Minor procedures which do not require penetration or exposure of a body cavity • Other reason(s) which may make them unsafe for VLCD based treatment as per clinical judgement of their treating surgeon (e.g. frailty or other advanced disease).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026