ObesityPREPARENCT05918471
PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery
A study testing Very Low Energy Diet with Liquid Supplementation in people with Obesity and Non-Bariatric Surgery, run by McMaster University at 4 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Non-Bariatric Surgery, Preoperative Weight Loss
- What is being tested?
- Very Low Energy Diet with Liquid Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesCanada
- Study dates
- 2 Jan 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites, 4 recruiting
- Recruiting
Hamilton General
Hamilton, Ontario, L8L 2X2
Mohit Bhandari, MD PhD, bhandam@mcmaster.ca
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Cagla Eskicioglu, MD MSc, eskicio@mcmaster.ca
- Recruiting
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
Mohit Bhandari, MD PhD, bhandam@mcmaster.ca
- Not yet recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Jordan Leitch, MD, Jordan.Leitch@kingstonhsc.ca
About this study
Official title: PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery: A Randomized Evaluation (PREPARE Pilot)
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.
Read the detailed description
Obesity is a worldwide epidemic affecting upwards of 700 million people. The economic burden in the United States and Canada are estimated at over $2 trillion and $100 billion United States dollars (USD), respectively, and the resultant healthcare consequences can be devastating for systems and patients alike. Obesity is a systemic disease with devastating consequences for patients undergoing any form of operative intervention. Obese patients presenting in need of medical and surgical intervention are at 2-to-6 fold higher risk of prolonged hospitalization, infectious morbidity, venous thromboembolism, and more. To pre-emptively mitigate some of these concerns, prescribed preoperative weight loss via VLEDs has become a standard of care for obese patients undergoing bariatric surgery (i.e., weight loss surgery). While VLEDs have become a standard in obese patients undergoing bariatric surgery, largely due to the significant reduction of peri-organ fat for better visualization, their application to obese patients undergoing other types of surgery remains limited. A previous systematic review and meta-analysis that identified 13 studies evaluating the use of preoperative VLEDs in obese patients undergoing orthopaedic, vascular, colorectal, upper gastrointestinal, gynecological, and a variety of general surgery procedures for benign disease (e.g., cholecystectomy, abdominal wall hernia). While data were heterogenous, preoperative VLEDs reliably resulted in significant weight loss (3.2-19.2kg) with high rates of compliance to the protocols (94-100%). Adverse event rates were low (<14% in most studies). There were no significant differences in postoperative outcomes, though again pooled analyses included a small number of patients and there were wide corresponding 95% CIs. Overall, this review suggested the evidence for routine use of VLEDs in obese patients undergoing major surgery is compromised by heterogeneous small studies with methodological limitations. A large, definitive trial is required to resolve this uncertainty. Prior to a definitive trial to compare the efficacy of VLEDs in obese patients undergoing major surgery, a pilot RCT is required. A pilot trial will provide the following critical feasibility insights: (1) Assessment of recruitment and randomization ability; (2) Evaluation of compliance to VLED regimens; and (3) Assessment of our ability follow patients completely. The objective of this pilot RCT is to determine the feasibility of a multicenter RCT comparing obese patients (i.e., BMI > 30kg/m2) receiving VLEDs versus control prior to elective non-bariatric surgery in terms of perioperative outcomes.
- Being tested
- Very Low Energy Diet with Liquid Supplementation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Low Energy Diet with Liquid SupplementationDietary supplement
Also called Optifast 900
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:
- Consume 4 Optifast 900 packets each day
- 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.
- Mix 1 sachet with at least 300 mL (1 1⁄4 cups) of cold water. Shake well or blend in a blender.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Defined as the number of patients randomized into the RCT per month.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (10)
VLED associated adverse events
The primary safety outcome will be all adverse events deemed secondary to the preoperative VLED. The adverse events will be recorded as dichotomous outcomes and described as either minor or serious, similarly to the OPTIWIN Study; the largest medical weight loss RCT evaluating VLEDs.
Measured: Three-week VLED intervention period.
Overall 30-day postoperative morbidity
This will be defined as any deviation from the usual postoperative course within 30-days of the index operation and will be a composite of system-specific complications.
Measured: 30-days following index operation.
30-day system-specific complications
Pre-defined system-specific outcomes based on most common postoperative complications following the included types of surgery.
Measured: 30-days following index operation.
30-day postoperative mortality
Death within 30 days of index surgery.
Measured: 30-days following index operation.
Preoperative weight loss
Preoperative weight loss will be assessed by measuring the post-VLED weight on the date of surgery and adjusting for the baseline weight in kg.
Measured: Three-week VLED intervention period.
Operative time
Operative time will be measured as the time between first skin incision and closure of the last surgical wound in minutes and will be retrieved from the patient EMRs.
Measured: Intraoperative
Intraoperative blood loss
This will be measured in milliliters and will be ascertained from the patient chart.
Measured: Intraoperative
Surgeon-perceived technical difficulty
Surgeon-perceived difficulty will be evaluated with a short electronic questionnaire administered immediately following completion of the case.
Measured: Intraoperative
Postoperative length of stay
This will be measured in days and will be ascertained from the patient chart.
Measured: Through postoperative stay, a mean of 3 days
Health-related quality of life
Utilizing Short Form-36. The lowest and highest possible scores are 0 and 100, respectively. A higher score is associated with a greater health-related quality of life.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start2 Jan 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-center, blinded, parallel pilot RCT.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University
- Responsible party
- Sponsor
- Investigators
- Tyler J McKechnie, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918471
- Sponsor's protocol ID
- 15946
- Acronym
- PREPARE
- Status last verified
- Jan 2024
- First submitted
- 18 May 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38773543
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery: A Randomized Evaluation (PREPARE Pilot)
- ClinicalTrials.gov ID
- NCT05918471
- Acronym / sponsor ID
- PREPARE / 15946
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Queen's University
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is a worldwide epidemic affecting upwards of 700 million people. The economic burden in the United States and Canada are estimated at over $2 trillion and $100 billion United States dollars (USD), respectively, and the resultant healthcare consequences can be devastating for systems and patients alike. Obesity is a systemic disease with devastating consequences for patients undergoing any form of operative intervention. Obese patients presenting in need of medical and surgical intervention are at 2-to-6 fold higher risk of prolonged hospitalization, infectious morbidity, venous thromboembolism, and more. To pre-emptively mitigate some of these concerns, prescribed preoperative weight loss via VLEDs has become a standard of care for obese patients undergoing bariatric surgery (i.e., weight loss surgery). While VLEDs have become a standard in obese patients undergoing bariatric surgery, largely due to the significant reduction of peri-organ fat for better visualization, their application to obese patients undergoing other types of surgery remains limited. A previous systematic review and meta-analysis that identified 13 studies evaluating the use of preoperative VLEDs in obese patients undergoing orthopaedic, vascular, colorectal, upper gastrointestinal, gynecological, and a variety of general surgery procedures for benign disease (e.g., cholecystectomy, abdominal wall hernia). While data were heterogenous, preoperative VLEDs reliably resulted in significant weight loss (3.2-19.2kg) with high rates of compliance to the protocols (94-100%). Adverse event rates were low (<14% in most studies). There were no significant differences in postoperative outcomes, though again pooled analyses included a small number of patients and there were wide corresponding 95% CIs. Overall, this review suggested the evidence for routine use of VLEDs in obese patients undergoing major surgery is compromised by heterogeneous small studies with methodological limitations. A large, definitive trial is required to resolve this uncertainty. Prior to a definitive trial to compare the efficacy of VLEDs in obese patients undergoing major surgery, a pilot RCT is required. A pilot trial will provide the following critical feasibility insights: (1) Assessment of recruitment and randomization ability; (2) Evaluation of compliance to VLED regimens; and (3) Assessment of our ability follow patients completely. The objective of this pilot RCT is to determine the feasibility of a multicenter RCT comparing obese patients (i.e., BMI > 30kg/m2) receiving VLEDs versus control prior to elective non-bariatric surgery in terms of perioperative outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multi-center, blinded, parallel pilot RCT.
| Arm | Type | Receives |
|---|---|---|
| Very Low Energy Diet + Standard Counselling | Experimental | Dietary Supplement: Very Low Energy Diet with Liquid SupplementationAll 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very Low Energy Diet with Liquid SupplementationAlso: Optifast 900The 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. | Dietary supplement | Very Low Energy Diet + Standard Counselling |
Primary outcome
Recruitment rate
Time frame: 1 year
Defined as the number of patients randomized into the RCT per month.
Intervention compliance
Time frame: 1 year
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.
Follow-up completion
Time frame: 1 year
Defined as completion of the pre-VLED, preoperative, and 30-day postoperative visits, along with complete anthropometric measures and study questionnaires.
Network development
Time frame: 1 year
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.
10 secondary outcomes
VLED associated adverse events
Time frame: Three-week VLED intervention period.
Overall 30-day postoperative morbidity
Time frame: 30-days following index operation.
30-day system-specific complications
Time frame: 30-days following index operation.
30-day postoperative mortality
Time frame: 30-days following index operation.
Preoperative weight loss
Time frame: Three-week VLED intervention period.
Operative time
Time frame: Intraoperative
Intraoperative blood loss
Time frame: Intraoperative
Surgeon-perceived technical difficulty
Time frame: Intraoperative
Postoperative length of stay
Time frame: Through postoperative stay, a mean of 3 days
Health-related quality of life
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 38773543McKechnie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler J McKechnie, MD principal investigator
McMaster University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very Low Energy Diet with Liquid Supplementation in people with Obesity and Non-Bariatric Surgery, run by McMaster University at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cagla Eskicioglu, MD, MSc (905-522-1155 ext. 35921, eskicio@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05918471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.