- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05136872
Continuous Observations of Behavioural Risk Factors in Asia (COBRA) (COBRA)
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Singapore, Singapore, 117549
- Saw Swee Hock School of Public Health, National University of Singapore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Movement behaviours
Time Frame: continuously for 9 days.
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Movement behaviours (i.e., physical activity, sedentary behaviour, sleep) are measured using a wrist-worn accelerometer.
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continuously for 9 days.
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Glucose concentrations
Time Frame: in 15-minute intervals over 9 days.
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Glucose concentrations are measured using a continuous glucose monitor sensor.
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in 15-minute intervals over 9 days.
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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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Self-reported stress level will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.
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Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
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Self-reported fatigue
Time Frame: Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
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Self-reported fatigue will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.
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Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
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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.
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Self-reported positive affect will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.
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Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
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Self-reported hunger
Time Frame: Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
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Self-reported hunger will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.
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Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rob M van Dam, PhD, National University of Singapore
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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