Clinical trial NCT06461247: Compliance With Standard Care vs Ready to Eat Meals Prior to Bariatric Surgery
Official title: Compliance With Standard Care vs Ready to Eat Meals Prior to Bariatric Surgery - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bariatric Surgery Candidate
Keywords: Weight loss
Very Low Calorie Diet
Body Weight
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Alexandra Hospital
First posted: 2024-06-14
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Compliance rate of the RTE meals
timeFrame: Daily for intervention period of 28 days
measure: Blood Ketones Measurement
timeFrame: 1st week, 2nd week, 3rd week, 4th week, surgery day
Secondary outcomes:
measure: Satisfaction of the RTE meals
timeFrame: 3rd week and surgery day
measure: Weight Change
timeFrame: 1st week, 2nd week, 3rd week, 4th week, surgery day
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alexandra Hospital
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Melissa Tay
role: PRINCIPAL_INVESTIGATOR
References: