Actively Recruiting

Phase Not Applicable
Age: 21Years - 65Years
All Genders
Healthy Volunteers
ID06461247

Compliance With Standard Care vs Ready to Eat Meals Prior to Bariatric Surgery A Randomised Controlled Trial

Led by National University Hospital, Singapore · Updated on 2025-09-12

140

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National University Hospital, Singapore

Lead Sponsor

A

Alexandra Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The rising obesity rates, including in Singapore, have increased the need for effective weight loss methods before bariatric surgery to reduce surgical risks and complications. This trial evaluates whether ready-to-eat Very Low Calorie Diet (VLCD) meals improve patient compliance and satisfaction compared to the standard liquid meal replacement used for preoperative dietary management. The study focuses on patients preparing for bariatric surgery, aiming to enhance adherence through more appealing meal options. Participants are randomly assigned to one of two groups: the standard care group receives liquid meal replacements for all meals over 4 weeks, while the intervention group receives VLCD ready-to-eat meals for lunch and dinner plus advice on a ketogenic breakfast. Both groups follow a diet limited to 800 calories and 50 grams of net carbohydrates daily. They use the Nutritionist Buddy Keto app to log meals, weight, and physical activity, receiving virtual reminders and dietitian support throughout the intervention. During the study, participants self-monitor their compliance via the app, with blood ketone levels measured weekly and on surgery day to assess adherence. Researchers also track meal satisfaction and weight changes over the 4-week period. The study aims to determine if the ready-to-eat meals lead to better compliance, as indicated by app logs and ketone measurements, ultimately supporting improved preoperative weight loss. Total participation lasts about one month before surgery.

CONDITIONS

Brief Title

Compliance With Standard Care vs Ready to Eat Meals Prior to Bariatric Surgery

Who Can Participate

Age: 21Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 21 to 65 years old
  • Scheduled for bariatric surgery at least 1 month prior
  • BMI ≥ 27.5 kg/m2 with type 2 diabetes mellitus or metabolic syndrome
  • Owns a smartphone with a data plan
  • English speaking
Not Eligible

You will not qualify if you...

  • Cognitive impairment
  • Hypothyroidism
  • Chronic kidney disease
  • Depression with ongoing psychology follow-up
  • Type 1 diabetes
  • Liver cirrhosis
  • Pregnancy
  • Heart failure
  • Active cancer or in remission for less than 5 years
  • Vegetarian diet
  • Observing the fast during the month of Ramadan
  • Currently undergoing treatment with anti-obesity medications such as Phentermine, Orlistat, Contrave, or GLP-1 analogues

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants follow a very low calorie diet for 4 weeks prior to bariatric surgery, either using liquid meal replacements or ready-to-eat ketogenic meals. They are guided by a dietitian and self-monitor their weight, diet, and physical activity using a mobile app with virtual reminders.

Weekly visits for 4 weeks

Follow-up

Duration - 1 day

Participants attend visits on surgery day for assessments including blood ketone measurements, satisfaction surveys, and weight monitoring.

1 visit (in-person) on surgery day

Trial Site Locations

Total: 2 locations

1

Alexandra Hospital

Singapore, Singapore

Actively Recruiting

2

National University Hospital

Singapore, Singapore

Actively Recruiting

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Research Team

M

Melissa Tay Hui Juan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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