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

National University Health System (NUHS)

Status: Enrolling

Conditions: Bariatric Surgery Candidate

Treatments: Other: Very Low Calorie Diet Ready-to-eat (VLCD RTE) meals; Other: Standard Care Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06461247

2024/00240

Details and patient eligibility

About

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.

Full 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).

Enrollment: 140 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 21 to 65 years old
• Scheduled for bariatric surgery at least 1 month prior
• Body Mass Index ≥ 32.5 kg/m2
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Very Low Calorie Diet Ready-to-eat (VLCD RTE) meals

Liquid Meal Replacement

Active Comparator group

Description:

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.

Treatment:

Other: Standard Care Group