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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06461247
Enrollment
140
Registered
2024-06-14
Start date
2024-07-01
Completion date
2026-09-30
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate

Keywords

Weight loss, Very Low Calorie Diet, Body Weight

Brief summary

Currently, a ketosis-inducing programme, usually a liquid meal replacement, is the standard of care for pre-operative dietary management. However, compliance with liduiqd meal replacement is challenging primarily due to individual taste preferences, limited variety, having to take a liquid diet, lifestyle factors, and other obstacles. Therefore, there is a need for RTE meals to enhance patient satisfaction and compliance, ultimately resulting in improved pre-operative weight loss outcomes. Hence, this RCT study aims to determine whether Very Low Calorie Diet Ready-to-eat (VLCD RTE) meals would lead to greater compliance as measured by blood ketones and meal logging via Nutritionist Buddy app (nBuddy App) compared to standard care liquid meal replacement (Optifast) prior to bariatric surgery.

Detailed description

The obesity rate in Singapore is rising, mirroring a similar worrying global trend. Bariatric surgery has been the only long-term method proven to overcome severe obesity and it has become an increasingly common and effective treatment option. Preoperative weight loss is required to reduce cardiovascular risk, liver volume and decrease intra-abdominal fat. This leads to enhanced surgical visibility and surgical access resulting in reduced intra- and postoperative complications. Currently, a ketosis-inducing programme, usually a liquid meal replacement, is the standard of care for pre-operative dietary management. However, compliance with liquid meal replacement is challenging primarily due to individual taste preferences, limited variety, having to take a liquid diet, lifestyle factors, and other obstacles. It was found for taste and gastrointestinal side effects to be the main issues. Therefore, RTE meals are carefully formulated to provide the calculated calorie, controlled net carbohydrate content, and are low in saturated and trans fat. By incorporating these meals as a VLCD diet regime, it would allow patients to still enjoy the chewing sensation and local favourites and flavours, while enjoying mealtime with their friends and families. In this randomised controlled trial, patients listed for bariatric surgery from the NUH Weight Management Clinic in Singapore will undergo randomization into either the Standard Care or Intervention group during the baseline visit. * Standard Care Group (n=70): Participants will be provided with liquid meal replacements for breakfast, lunch, and dinner for 4 weeks. Additionally, patients are to prepare 1 serving of non-starchy vegetables are to be included for lunch and dinner. * Intervention Group (n=70): Participants will be provided with the VLCD RTE meals for lunch and dinner for 4 weeks and advised on a healthy keto breakfast. All eligible participants (n=140) will be advised to keep within the 800 calorie limit and 50g net carbohydrate limit per day. They will receive guidance from a dietitian on lifestyle changes and pre-bariatric surgery VLCD diets. Participants in both groups will also be advised to download the nutritionist Buddy Keto app for monitoring of compliance, food intake, steps count, weight progress and in app virtual reminders (automated and by dietitians via the chat function).

Interventions

OTHERVery Low Calorie Diet Ready-to-eat (VLCD RTE) meals

Participants will be provided with VLCD RTE meals for lunch and dinner for 4 weeks and advised on a healthy ketogenic breakfast. Participant will be expected to adhere to VLCD regimen containing 800 calories per day or fewer and keep within 50g net carbohydrates a day.

Participants will be provided with liquid meal replacement for breakfast, lunch, and dinner for 4 weeks. Additionally, patients are to prepare 1 serving of non-starchy vegetables are to be included for lunch and dinner. Participant will be expected to adhere to VLCD regimen containing 800 calories per day or fewer and keep within 50g net carbohydrates a day.

Sponsors

Alexandra Hospital
CollaboratorOTHER
National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

It is not feasible to apply blinding to the study design due to the nature of the intervention.

Intervention model description

Standard Care Group (n=70): Participants will be having liquid meal replacement for breakfast, lunch, and dinner for 4 weeks. Additionally, patients are to prepare 1 serving of non-starchy vegetables are to be included for lunch and dinner. Intervention Group (n=70): Participants will be provided with VLCD RTE meals for lunch and dinner for 4 weeks and advised on a healthy keto breakfast. Both groups will be recommended to keep within the calorie limit to 800kcal and 50g net carbohydrates per day.

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Compliance rate of the RTE mealsDaily for intervention period of 28 daysThe compliance rate is assessed via food logging in the nutritionist buddy keto app
Blood Ketones Measurement1st week, 2nd week, 3rd week, 4th week, surgery dayFasting blood ketone measurements measured at study visit

Secondary

MeasureTime frameDescription
Satisfaction of the RTE meals3rd week and surgery dayAssessed via a self-reported questionnaire with a numeric scale of 1 to 5
Weight Change1st week, 2nd week, 3rd week, 4th week, surgery dayWeight changes at study visit

Countries

Singapore

Contacts

Primary ContactMelissa Tay Hui Juan
melissa_hj_tay@nuhs.edu.sg67725166

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026