Comparing Ready-to-Eat Meals with Standard Care for Bariatric Surgery Preparation
Compliance With Standard Care vs Ready to Eat Meals Prior to Bariatric Surgery - a Randomised Controlled Trial
This study is testing if ready-to-eat low-calorie meals can help people preparing for bariatric surgery stick to their diet better and feel more satisfied compared to regular liquid meal replacements.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Locations | 2 sites (Singapore and 1 other locations) |
| Trial ID | NCT06461247 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Very Low Calorie Diet Ready-to-eat (VLCD RTE) meals compared to standard liquid meal replacements for patients preparing for bariatric surgery. The study aims to enhance patient compliance and satisfaction by providing a more enjoyable meal option that still meets dietary requirements. Participants will be randomized into two groups: one receiving the VLCD RTE meals and the other following the standard care protocol. Compliance will be measured through blood ketone levels and meal logging using the Nutritionist Buddy app.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 65 years scheduled for bariatric surgery with a BMI of 32.5 kg/m2 or higher.
Not a fit: Patients with cognitive impairments, chronic illnesses, or specific dietary restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve pre-operative weight loss outcomes and patient satisfaction for those undergoing bariatric surgery.
How similar studies have performed: Other studies have shown that alternative dietary approaches can improve compliance and outcomes, suggesting potential success for this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 smart phone with data plan * English speaking Exclusion Criteria: * Cognitive impairment. * Hypothyroidism * Chronic kidney disease * Hypothyroidism * 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 * Observing the fast during the month of Ramadan * Undergoing treatment with anti obesity medications (eg: Phentermine/Orlistat/Contrave/GLP-1 analogues etc)
Where this trial is running
Singapore and 1 other locations
- Alexandra Hospital — Singapore, Singapore (Recruiting)
- National University Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Melissa Tay — National University Hospital, Singapore
- Study coordinator: Melissa Tay Hui Juan
- Email: melissa_hj_tay@nuhs.edu.sg
- Phone: 67725166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.