Clinical trial NCT05136872: Continuous Observations of Behavioural Risk Factors in Asia (COBRA)
Official title: Continuous Observations of Behavioural Risk Factors in Asia (COBRA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behavior
Diet, Healthy
Physical Activity
Sedentary Behavior
Sleep
Keywords: health behavior
physical activity
sedentary
sleep
eating behavior
GPS
glycaemic response
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
First posted: 2021-11-29
Enrollment: 1361
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults in Singapore

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

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* aged 21 to 69 years of age
* citizen or permanent resident of Singapore
* of Chinese, Malay, or Indian ethnicity
* able to read English
* own or have continued access to a smartphone with a data plan
* able to use smartphone apps
* able to walk independently

Exclusion criteria:

* history of stroke, heart disease, renal failure, diabetes mellitus, thyroid disease, cancer, or a serious mental health condition (e.g., schizophrenia, depression, or dementia)
* have had vascular bypass surgery or angioplasty procedure performed
* known sensitivity to medical-grade adhesives
* bleeding disorder

Primary outcomes:
measure: Movement behaviours
timeFrame: continuously for 9 days.
measure: Glucose concentrations
timeFrame: in 15-minute intervals over 9 days.
measure: Self-reported food intake
timeFrame: 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
measure: Self-reported movement behaviours
timeFrame: 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
measure: Self-reported screen time
timeFrame: 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
Secondary outcomes:
measure: Self-reported stress levels
timeFrame: Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
measure: Self-reported fatigue
timeFrame: Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
measure: Self-reported positive affect
timeFrame: Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
measure: Self-reported hunger
timeFrame: Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Saw Swee Hock School of Public Health, National University of Singapore
Study officials:
affiliation: National University of Singapore
name: Rob M van Dam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edney SM, Park SH, Tan L, Chua XH, Dickens BSL, Rebello SA, Petrunoff N, Muller AM, Tan CS, Muller-Riemenschneider F, van Dam RM. Advancing understanding of dietary and movement behaviours in an Asian population through real-time monitoring: Protocol of the Continuous Observations of Behavioural Risk Factors in Asia study (COBRA). Digit Health. 2022 Jun 30;8:20552076221110534. doi: 10.1177/20552076221110534. eCollection 2022 Jan-Dec.