Continuous Observations of Behavioural Risk Factors in Asia (COBRA) (COBRA)

September 11, 2024 updated by: Rob M van Dam, National University of Singapore
The aim of this study is to advance understanding of behavioural risk factors for cardiovascular disease and type 2 diabetes in Singapore.

Study Overview

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 Type

Observational

Enrollment (Actual)

1361

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 117549
        • Saw Swee Hock School of Public Health, National University of Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults in Singapore

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
Self-reported stress levels
Time Frame: 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.
Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
Self-reported fatigue
Time Frame: 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.
Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
Self-reported positive affect
Time Frame: 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.
Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
Self-reported hunger
Time Frame: 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.
Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rob M van Dam, PhD, National University of Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Actual)

August 26, 2024

Study Completion (Actual)

August 26, 2024

Study Registration Dates

First Submitted

November 14, 2021

First Submitted That Met QC Criteria

November 14, 2021

First Posted (Actual)

November 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • NUS-IRB-2020-50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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