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| Name | Class |
|---|---|
| Alexandra Hospital | OTHER |
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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.
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very Low Calorie Diet Ready-to-eat (VLCD RTE) meals | Experimental | Participants (n=70) in the VLCD RTE meals group will be advised to follow a calorie-restricted healthy ketogenic diet , consuming a maximum of 800 calories and 50g net carbohydrate intake daily. Participants will be provided with VLCD RTE meals for lunch and dinner for 4 weeks and advised on a healthy keto breakfast. The participants will be expected to self-monitor their weight, physical activity and diet logs via the nutritionist buddy keto app. There will be in app virtual reminders (automated and by dietitians via the chat function) sent via the nutritionist buddy keto application for the 1 month for participants to log in their weight and meals. |
|
| Liquid Meal Replacement | Active Comparator | Participants (n=70) in the liquid meal replacement group will be advised to follow very low-calorie diet, with a maximum of 800 calories and 50g net carbohydrate intake daily. Participants will be provided with a 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. The participants will be expected to self-monitor their weight, physical activity and diet logs via the nutritionist buddy keto app. There will be in app virtual reminders (automated and by dietitians via the chat function) sent via the nutritionist buddy keto application for the 1 month for participants to log in their weight and meals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very Low Calorie Diet Ready-to-eat (VLCD RTE) meals | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance rate of the RTE meals | The compliance rate is assessed via food logging in the nutritionist buddy keto app | Daily for intervention period of 28 days |
| Blood Ketones Measurement | Fasting blood ketone measurements measured at study visit | 1st week, 2nd week, 3rd week, 4th week, surgery day |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of the RTE meals | Assessed via a self-reported questionnaire with a numeric scale of 1 to 5 | 3rd week and surgery day |
| Weight Change | Weight changes at study visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Tay Hui Juan | Contact | 67725166 | melissa_hj_tay@nuhs.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Melissa Tay | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandra Hospital | Recruiting | Singapore | Singapore |
Individual participant data will remain confidential and only accessible via lock and keys by the researchers.
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062407 | Meals |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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.
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It is not feasible to apply blinding to the study design due to the nature of the intervention.
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| Standard Care Group | Other | 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. |
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| 1st week, 2nd week, 3rd week, 4th week, surgery day |
| National University Hospital | Recruiting | Singapore | Singapore |
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