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临床试验/NCT05136872
NCT05136872招募中不适用

Continuous Observations of Behavioural Risk Factors in Asia (COBRA)

National University of Singapore1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年5月5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
1,500
试验地点
1
主要终点
Glucose concentrations

研究概览

简要总结

The aim of this study is to advance understanding of behavioural risk factors for cardiovascular disease and type 2 diabetes in Singapore.

详细描述

BACKGROUND: Modifiable risk factors for non-communicable diseases, including unhealthy diets and movement behaviours, are influenced by complex and dynamic interactions between people and their social and physical environment. Therefore, understanding patterns and determinants of these risk factors as they occur in real-life is essential to enable the design of precision public health interventions.

AIMS: The aims of this study are to (1) examine patterns of dietary and movement behaviours in real-time as people go about their daily lives, (2) examine how interactions with the social and physical environment influence dietary and movement behaviours, and (3) examine how these patterns differ by ethnicity and other socio-demographic characteristics.

METHOD: This is an observational study in free-living participants over 10 consecutive days, with a 9-day follow-up 6 months later. 1500 participants will be recruited from a large prospective cohort study. Real-time data capture strategies will be used: an ecological momentary assessment (EMA) app with global positioning system (GPS) enabled to collect location data, accelerometers to measure movement, and wearable sensors to monitor blood glucose levels. Participants receive six EMA prompts per day to capture information on diet and movement behaviours (physical activity, sedentary behaviour, sleep), and related contextual factors. A second wave of EMA prompts and GPS monitoring will occur 6 months later. Data will be integrated and analysed using generalised linear models to examine associations between behavioural risk factors and contextual determinants.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Glucose concentrations

时间窗: in 15-minute intervals over 9 days.

Glucose concentrations are measured using a continuous glucose monitor sensor.

Self-reported movement behaviours

时间窗: Change in self-reported movement behaviours over time. Data will be collected at 2.5-hour intervals between 8am and 9.30pm over a period of 9 days, and repeated at the 6-month follow-up

Self-reported movement behaviours (i.e., physical activity, sedentary behaviour, sleep) through entering of the type and social and physical environment context of activity via an Ecological Momentary Assessment (EMA) smartphone app.

Self-reported screen time

时间窗: Change in self-reported screen time over time. Data will be collected at 2.5-hour intervals between 8am and 9.30pm over a period of 9 days, and repeated at the 6-month follow-up

Self-reported screen time through entering of the type of screen used and the purpose and the duration of screen time via an Ecological Momentary Assessment (EMA) smartphone app.

Movement behaviours

时间窗: continuously for 9 days.

Movement behaviours (i.e., physical activity, sedentary behaviour, sleep) are measured using a wrist-worn accelerometer.

Self-reported food intake

时间窗: Change in self-reported food intake over time. Data will be collected at 2.5-hour intervals between 8am and 9.30pm over a period of 9 days, and repeated at the 6-month follow-up

Self-reported food intake measurement through entering of food items and the social and physical environment of eating via an Ecological Momentary Assessment (EMA) smartphone app.

次要结局

  • Self-reported hunger(Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.)
  • Self-reported fatigue(Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.)
  • Self-reported positive affect(Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.)
  • Self-reported stress levels(Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.)

研究者

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

Rob M van Dam

Professor

National University of Singapore

研究点 (1)

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