Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461247
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-05
Brief Title:
Compliance With Standard Care vs Ready to Eat Meals Prior to Bariatric Surgery
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Compliance With Standard Care vs Ready to Eat Meals Prior to Bariatric Surgery - a Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n70 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 n70 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 n140 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
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 n70 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 n70 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 n140 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None