Continuous Observations of Behavioural Risk Factors in Asia (COBRA)

Recruiting

• Conditions: Health Behavior; Diet, Healthy; Physical Activity; Sedentary Behavior; Sleep

• Registration Number: NCT05136872
• Lead Sponsor: National University of 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.

Study Timeline

• Study Start: 2021-05-05
• Study First Submitted: 2021-11-14
• Study First Submitted QC: 2021-11-14
• Study First Posted: 2021-11-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29
• Primary Completion: 2023-12
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glucose concentrations	in 15-minute intervals over 9 days.	Glucose concentrations are measured using a continuous glucose monitor sensor.
Self-reported movement behaviours	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	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	continuously for 9 days.	Movement behaviours (i.e., physical activity, sedentary behaviour, sleep) are measured using a wrist-worn accelerometer.
Self-reported food intake	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.

Secondary Outcome Measures

Name	Time	Method
Self-reported hunger	Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.	Self-reported hunger will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.
Self-reported fatigue	Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.	Self-reported fatigue will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.
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 positive affect will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.
Self-reported stress levels	Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.	Self-reported stress level will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.

Trial Locations

Locations (1)

Saw Swee Hock School of Public Health, National University of Singapore; 🇸🇬 Singapore, Singapore