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临床试验/NCT06022796
NCT06022796招募中不适用

Weight Loss Interventions for Obesity

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年7月21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
50
试验地点
2
主要终点
Body weight

研究概览

简要总结

Numerous barriers towards weight management among Singaporeans with obesity exists, which involves environmental and self-regulation factors (i.e. motivation and hunger). Hence, the provision of healthy ketogenic ready-to-eat meals may be a potential solution to facilitate initial weight loss through increasing motivation while reducing appetite and hunger levels among these individuals. Therefore, this study will investigate the effect of healthy ketogenic ready-to-eat meals with mHealth nutrition application versus healthy ketogenic diet (without meal provision) with the mHealth nutrition app to facilitate weight loss and improve metabolic outcomes among individuals with obesity.

详细描述

In Singapore, the widespread availability of local meals and concerns of overconsumption due to a lack of internal self-regulation skills for hunger predisposes an increased energy intake. Furthermore, a lack of time, motivation, and self-efficacy in preparing healthy meals may potentially limit the extent of weight and dietary management among local individuals with obesity.

The ketogenic diet has consistently demonstrated beneficial effects on facilitating weight management. This weight loss mechanism involves achieving a calorie deficit, induced state of nutritional ketosis, and the reduction in appetite and hunger. Importantly, the weight loss achieved from the early phase of the intervention serves as one of the key enablers in the weight loss process. Despite these benefits, there is paucity in the literature examining the provision of healthy ketogenic ready-to-eat (HK-RTE) meals on weight loss. Furthermore, none of these studies explored the extent of motivation derived from the benefits of these meals, nor included the use of mHealth self-monitoring strategies to encourage weight loss.

To address the research gap, our study aims to evaluate the effectiveness of HK-RTE meals with mHealth app, as compared to healthy ketogenic diet (HKD) (without meal provision) using the mHealth app on weight loss and metabolic outcomes among Asian individuals with obesity.

In this randomized controlled trial, participants will be randomized to either HK-RTE group or the HKD group using computer-generated random sequencing. Both groups will receive nutrition education conducted by dietitians throughout the 6-month study period (total of 5 dietary workshops covering topics such as ketogenic dietary advice and self-monitoring habits).

The HK-RTE group will be provided with HK-RTE meals for lunch and dinner in the first month (n = 25). They are to take these meals as part of a healthy ketogenic diet, with a maximum of 50g net total carbohydrates daily. Those in the control group will be advised to follow a healthy ketogenic diet (HKD) without the RTE meals (n = 25) and similarly to keep to a maximum of 50g net carbohydrates daily. Participants will also be encouraged to use the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, physical activity and weight throughout the 6-month study period. The impact of the HK-RTE meals on motivation and appetite regulation in influencing weight loss will also be explored.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 21 to 75 years old
  • Body Mass Index >= 27.5kg/m2
  • Own a smartphone
  • Literacy in English
  • NUH staff

排除标准

  • Intention of pregnancy; Pregnancy; Lactating individuals
  • Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus on insulin treatment
  • Untreated Endocrinopathy (e.g., hyper/hypothyroidism)
  • Advanced kidney disease
  • Abnormal liver function test assessed at screening
  • Heart diseases
  • Severe cognitive or psychiatric disabilities/disorders (e.g., eating disorders, depression)
  • Active malignancies
  • Taking medications that affect appetite or induce weight loss; previous or plans for bariatric surgery.

结局指标

主要结局

Body weight

时间窗: 1 month, 3 months, 6 months

Weight changes post-intervention

次要结局

  • Blood pressure(3 months, 6 months)
  • Motivation to initiate and maintain dietary behaviours(3 months, 6 months)
  • Hunger(3 months, 6 months)
  • Hemoglobin A1c(3 months, 6 months)
  • High-density lipoprotein cholesterol(3 months, 6 months)
  • Dietary intake(6 months)
  • Fasting blood glucose(3 months, 6 months)
  • Total cholesterol(3 months, 6 months)
  • Low-density lipoprotein cholesterol(3 months, 6 months)
  • Triglycerides(3 months, 6 months)
  • Perceived competence to maintain dietary behaviour(3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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