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Very Low Energy Diet for Obesity Before Surgery (PREPARE Trial)
Hamilton, Canada
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
No Placebo-Only Group
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
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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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Follow-up completion
Intervention compliance
Network development
+1 moreSecondary study objectives
30-day postoperative mortality
30-day system-specific complications
Health-related quality of life
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Closest Location:St. Joseph's Healthcare Hamilton· Hamilton, Canada
Who is running the clinical trial?
Queen's UniversityOTHER
381 Previous Clinical Trials
122,671 Total Patients Enrolled
9 Trials studying Obesity
4,166 Patients Enrolled for Obesity
McMaster UniversityLead Sponsor
934 Previous Clinical Trials
2,620,844 Total Patients Enrolled
16 Trials studying Obesity
1,358 Patients Enrolled for Obesity
Tyler J McKechnie, MDPrincipal InvestigatorMcMaster University