PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery

NCT05918471 | Unknown DMC

• 1 other identifier: 15946
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 4

Brief Summary

The PREPARE Pilot randomized controlled trial (RCT) is a multi-center, parallel, blinded RCT that aims to assess the feasibility of a full RCT comparing preoperative very low energy diets (VLEDs) to standard of care prior to elective non-bariatric surgery for obese patients in terms of overall 30-day postoperative morbidity. Adult patients with body mass indices (BMIs) greater than 30 kg/m2 will be randomized 1:1 to receive 3-weeks of preoperative VLED plus preoperative weight loss counselling or preoperative weight loss counselling alone. This trial will enroll patients to assess recruitment, compliance, and follow-up completion to assess the feasibility of a full RCT powered to assess for differences in 30-day postoperative between VLEDs and standard of care arms.

Conditions

Obesity; Non-Bariatric Surgery; Preoperative Weight Loss; Preoperative Optimization

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Defined as the number of patients randomized into the RCT per month.

  1 year

• Intervention compliance

  Defined as the number of preoperative VLED doses taken divided by the total number of doses prescribed for each participant randomized to the intervention arm.

  1 year

• Follow-up completion

  Defined as completion of the pre-VLED, preoperative, and 30-day postoperative visits, along with complete anthropometric measures and study questionnaires.

  1 year

• Network development

  Defined as recruiting from all three participating centers at the aforementioned rate. Additionally, we will aim to extend our multi-disciplinary network to at least 10 centers throughout the course of this pilot RCT in preparation for the full RCT.

  1 year

Secondary Outcomes (10)

• VLED associated adverse events

  Three-week VLED intervention period.

• Overall 30-day postoperative morbidity

  30-days following index operation.

• 30-day system-specific complications

  30-days following index operation.

• 30-day postoperative mortality

  30-days following index operation.

• Preoperative weight loss

  Three-week VLED intervention period.

Study Arms (2)

Very Low Energy Diet + Standard Counselling

EXPERIMENTAL

All patients in the intervention group will receive standard patient counselling on weight loss and an active VLED protocol. The preoperative VLED protocol will utilize Optifast 900, a commercially available weight loss product sold by Nestlé Health Sciences. Optifast 900 is designed as a high-protein, low-carbohydrate, and low-fat meal replacement with complete micronutrient composition. Patients will receive a three-week supply. They will be instructed to consume four packets daily. This provides a total energy intake of 900 kcal. Patients will also be able to consume up to 2 cups of low-calorie vegetables per day along with the meal replacement product. They will be provided with a handout containing specific instructions. Patients will keep self-report diaries of their dietary intake and activity levels.

Dietary Supplement: Very Low Energy Diet with Liquid Supplementation

Standard Counselling Alone

NO INTERVENTION

The control group patients will receive standard counselling for weight loss without prescription of a specific preoperative weight loss intervention, as this is meant to be a pragmatic trial. Currently, there are no standardized interventions aimed at optimizing obese patients prior to undergoing non-bariatric surgery. Briefly, counselling will consist of the surgeon, at the time of the preoperative clinic visit, discussing weight loss strategies such as decreased caloric intake and increased physical activity. Patients will not receive prescriptions for preoperative VLEDs, any other weight loss supplement, or any physical activity intervention aimed at promoting weight loss prior to surgery. Patients will keep self-report diaries of their dietary intake and activity levels.

Interventions

Very Low Energy Diet with Liquid Supplementation DIETARY_SUPPLEMENT

The preoperative VLED protocol will utilize Optifast 900, a commercially available weight loss product sold by Nestlé Health Sciences. Optifast 900 is designed as a high-protein, low-carbohydrate, and low-fat meal replacement with complete micronutrient composition. Instructions for use are as follows: 1. Consume 4 Optifast 900 packets each day 2. Take 1 sachet of Optifast 900 once in the morning (AM), once at noon, once in the early evening (PM #1), and once later in the evening (PM #2) for three-weeks. 3. Mix 1 sachet with at least 300 mL (1 1⁄4 cups) of cold water. Shake well or blend in a blender.

Also known as: Optifast 900

Very Low Energy Diet + Standard Counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years of age
• BMI of greater than 30 kg/m2
• Undergoing major elective non-bariatric surgery. Major surgery is defined as any operation performed under general anesthesia requiring a skin incision extending beyond the subcutaneous tissue.

You may not qualify if:

• Undergoing bariatric surgery
• Undergoing neurologic surgery
• Undergoing urgent or emergent surgery
• Recently diagnosed myocardial infarction or unstable angina (i.e., within past six months)
• Diagnosed moderate-to-severe renal dysfunction (i.e., eGFR less than 30mL/min/1.73m2)
• Diagnosed severe liver dysfunction (i.e., cirrhosis, portal hypertension, hepatic encephalopathy, hepatorenal syndrome)
• Recently diagnosed alcohol or drug use disorders (i.e., excessive use of substance within past six months)
• Experienced a recent episode of gout (i.e., within past six months)
• Medical history of porphyria; (10) Known allergy to any Optifast ingredient
• Enrolled in other prospective studies with similar interventions and/or outcomes. Co-enrollment may be deemed appropriate if the steering committees of the respective trials review the details of participation.
• Pregnant or breastfeeding women
• Patients unable to provide informed consent.

Sponsors & Collaborators

• McMaster University: lead
• Queen's University: collaborator

Study Sites (4)

Hamilton General

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

NOT YET RECRUITING

Related Publications (1)

• McKechnie T, Ramji K, Saddik M, Leitch J, Farooq A, Patel S, Doumouras A, Parpia S, Eskicioglu C, Bhandari M. PReoperative very low-Energy diets for obese PAtients undergoing non-bariatric surgery Randomized Evaluation (PREPARE): a protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2024 May 21;10(1):82. doi: 10.1186/s40814-024-01511-6.

  PMID: 38773543 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tyler J McKechnie, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cagla Eskicioglu, MD, MSc

CONTACT

905-522-1155; eskicio@mcmaster.ca

Tyler J McKechnie, MD

CONTACT

6138689442; tyler.mckechnie@medportal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surgeons, investigators, outcome assessors, and data analysts will be blinded to treatment allocation to limit measurement bias
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multi-center, blinded, parallel pilot RCT.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 26, 2023
• Study Start: January 2, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 31, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)