Health BehaviorCOBRANCT05136872
Continuous Observations of Behavioural Risk Factors in Asia (COBRA)
An observational study of Health Behavior and Diet, Healthy, run by National University of Singapore at 1 site in Singapore.
Trial summary
The aim of this study is to advance understanding of behavioural risk factors for cardiovascular disease and type 2 diabetes in Singapore. Read more about this study
- Who is it for?
- Ages 21 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Diet, Healthy, Physical Activity
- How many people
- 1,361 participants
- Where
- 1 siteSingapore
- Study dates
- 5 May 2021to 26 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults in Singapore
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Saw Swee Hock School of Public Health, National University of Singapore
Singapore, 117549
About this study
The aim of this study is to advance understanding of behavioural risk factors for cardiovascular disease and type 2 diabetes in Singapore.
Read the 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.
- Conditions
- Health Behavior, Diet, Healthy, Physical Activity, Sedentary Behavior, Sleep
- Keywords
- health behavior, physical activity, sedentary, sleep, eating behavior, GPS, glycaemic response
- Medical subject headings
- Health Behavior, Motor Activity, Sedentary Behavior, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement behaviours
Movement behaviours (i.e., physical activity, sedentary behaviour, sleep) are measured using a wrist-worn accelerometer.
Measured: continuously for 9 days.
Glucose concentrations
Glucose concentrations are measured using a continuous glucose monitor sensor.
Measured: in 15-minute intervals over 9 days.
Self-reported food intake
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 (4)
Self-reported stress levels
Self-reported stress level will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.
Measured: Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
Self-reported fatigue
Self-reported fatigue will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.
Measured: Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
Self-reported positive affect
Self-reported positive affect will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.
Measured: Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
Self-reported hunger
Self-reported hunger will be assessed via an Ecological Momentary Assessment (EMA) smartphone app.
Measured: Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start5 May 2021
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,361 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Responsible party
- Principal investigator, Rob M van Dam, National University of Singapore
- Investigators
- Rob M van Dam, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136872
- Sponsor's protocol ID
- NUS-IRB-2020-50
- Acronym
- COBRA
- Status last verified
- Sep 2024
- First submitted
- 14 Nov 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35795338
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Observations of Behavioural Risk Factors in Asia (COBRA)
- ClinicalTrials.gov ID
- NCT05136872
- Acronym / sponsor ID
- COBRA / NUS-IRB-2020-50
- Conditions
- Health Behavior, Diet, Healthy, Physical Activity, Sedentary Behavior, Sleep
- Keywords
- health behavior, physical activity, sedentary, sleep, eating behavior, GPS, glycaemic response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,361 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Study start
- 5 May 2021 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 29 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults in Singapore
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Movement behaviours
Time frame: continuously for 9 days.
Movement behaviours (i.e., physical activity, sedentary behaviour, sleep) are measured using a wrist-worn accelerometer.
Glucose concentrations
Time frame: in 15-minute intervals over 9 days.
Glucose concentrations are measured using a continuous glucose monitor sensor.
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.
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.
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.
4 secondary outcomes
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 fatigue
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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 35795338Edney 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.
- Individual participant dataSharing planned: No
Related trials for Health Behavior
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob M van Dam, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior and Diet, Healthy, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement behaviours (time frame: continuously for 9 days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05136872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.