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临床试验/NCT06461247
NCT06461247招募中不适用

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

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
2
主要终点
Blood Ketones Measurement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

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

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Blood Ketones Measurement

时间窗: 1st week, 2nd week, 3rd week, 4th week, surgery day

Fasting blood ketone measurements measured at study visit

Compliance rate of the RTE meals

时间窗: Daily for intervention period of 28 days

The compliance rate is assessed via food logging in the nutritionist buddy keto app

次要结局

  • Satisfaction of the RTE meals(3rd week and surgery day)
  • Weight Change(1st week, 2nd week, 3rd week, 4th week, surgery day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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