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临床试验/NCT04905680
NCT04905680Unknown不适用

GluCoach - Technology-enabled Lifestyle Intervention Study

National University of Singapore2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2021年5月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
260
试验地点
2
主要终点
Behaviour, self-efficacy and attitudes

研究概览

简要总结

This study seeks to address two questions. Firstly, how might a suite of interventions and data feedback (activity, diet, mood*, continuous blood glucose) through coaching be effective in influencing behaviour change for individuals at-risk of developing type 2 diabetes? Secondly, what elements of coaching might be extracted for automated implementation in a scalable coach-light model?

详细描述

Face-to-face health coaching is a common lifestyle intervention for healthy individuals who are at risk of chronic diseases such as diabetes. However, it is highly resource-intensive and has limitations in scaling up to reach wider populations. Advances in technology present opportunities to scale health coaching to the wider population through automation, enabling the delivery of personalised messages for individuals via mobile applications.

In addition, continuous glucose monitoring (CGM) devices could also potentially augment the effectiveness of health coaching by providing coaches with a tool for coachees' self-discovery of their individual physiological responses to lifestyles and modifications such as diet and exercise.

As such, the present study seeks to leverage smart wearable devices (e.g., Bluetooth smartwatches) and CGM devices accompanying a customized mobile application to deliver lifestyle coaching interventions. This suite of lifestyle interventions, including feedback about their own blood glucose levels, aims to influence participant's lifestyles and behaviours through guided self-discovery and face-to-face coaching. This intervention will be compared with a control group to examine its effects on lifestyle change, anthropometric measures and biometric measures. In addition, the findings from this study will contribute to the development of a novel coach-light intervention that can be implemented at a wider population level via Singapore's Health Promotion Board's (HPB) existing programmes and channels.

研究设计

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

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Singaporean Citizens and Permanent Residents
  • Aged 21 to 55
  • Must be literate in English (i.e. able to read and communicate in English) because the primary mode of communication is English
  • Willing and able to use a smartphone
  • Must be at risk of developing Type 2 Diabetes, defined as:
  • i) Glycated haemoglobin (HbA1c) - At least 5.7% to 6.5% OR Fasting blood glucose of 6.1 to 6.9mmol/L, AND ii) BMI of at least 20kg/m2

排除标准

  • Non-Singaporean Citizens and Permanent Residents
  • Under age 21 or above age 55
  • Ever diagnosed as Type 1 or Type 2 Diabetic (does not include previously diagnosed GDM)
  • Pregnant or planning to be pregnant in the next 6 months or lactating
  • History of skin allergies
  • Taking medications that are known to alter blood sugar levels/ glucose tolerance e.g.
  • glucocorticoids g) History of mental illness/conditions h) Work requirement that does not allow the carrying of electronic devices (e.g., phone and smartwatch) i) Frequent overseas travelling (e.g., more frequently than once a month, daily or weekly commuting across borders etc.)

结局指标

主要结局

Behaviour, self-efficacy and attitudes

时间窗: Baseline and at month 3

Change in behaviour, self-efficacy and attitudes towards diet and exercise from baseline to 3rd month

次要结局

  • HbA1c concentration(Baseline and at month 3)
  • Plasma glucose concentration(Baseline and at month 3)
  • BMI(Baseline and at month 3)
  • Lipid profile(Baseline and at month 3)
  • Systolic and Diastolic Blood pressure(Baseline and at month 3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Falk Mueller-Riemenschneider

Associate Professor

National University of Singapore

研究点 (2)

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