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Very Low Energy Diet + Standard Counselling for Obesity (PREPARE Trial)

N/A
Recruiting
Led By Tyler J McKechnie, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Older than 18 years of age
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

PREPARE Trial Summary

This trial is testing whether a very low energy diet before surgery is helpful for obese patients. Participants will be randomly assigned to either receive the diet and counseling or just counseling. The trial will look at how

Who is the study for?
This trial is for adults over 18 with obesity (BMI over 30) who are scheduled for major elective surgery that isn't weight loss surgery. Participants must be able to undergo general anesthesia and a significant surgical procedure.Check my eligibility
What is being tested?
The PREPARE Pilot study tests if a very low energy diet with liquid supplements for three weeks before surgery can improve outcomes compared to just getting weight loss counseling. It's a test run to see if it's feasible to do a larger study on this.See study design
What are the potential side effects?
Potential side effects from the very low energy diet may include fatigue, dizziness, constipation, or nutrient deficiencies due to the drastic reduction in calorie intake.

PREPARE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I am scheduled for a major surgery that is not for weight loss and requires general anesthesia.

PREPARE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Follow-up completion
Intervention compliance
Network development
+1 more
Secondary outcome measures
30-day postoperative mortality
30-day system-specific complications
Health-related quality of life
+7 more

PREPARE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Very Low Energy Diet + Standard CounsellingExperimental Treatment1 Intervention
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.
Group II: Standard Counselling AloneActive Control1 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.

Find a Location

Who is running the clinical trial?

Queen's UniversityOTHER
366 Previous Clinical Trials
121,649 Total Patients Enrolled
9 Trials studying Obesity
4,166 Patients Enrolled for Obesity
McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,598,228 Total Patients Enrolled
15 Trials studying Obesity
1,284 Patients Enrolled for Obesity
Tyler J McKechnie, MDPrincipal InvestigatorMcMaster University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the process of enrolling participants currently underway for this clinical trial?

"Indeed, as documented on clinicaltrials.gov, this ongoing clinical trial is currently seeking eligible participants. The study was initially made available for public viewing and participation on January 2nd, 2024, with the most recent update occurring on January 3rd, 2024."

Answered by AI

What is the current number of participants being recruited for this medical research study?

"Indeed, the information provided on clinicaltrials.gov confirms that this research study is actively seeking eligible participants. The trial was first posted on January 2nd, 2024 and was last updated on January 3rd, 2024. The aim of the trial is to recruit a total of 88 patients across four distinct locations."

Answered by AI

Who else is applying?

What site did they apply to?
Kingston Health Sciences Centre
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery
2024. "PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05918471.
~50 spots leftby Sep 2024
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