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

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ClinicalTrials.gov Identifier: NCT05136872
Recruitment Status : Recruiting
First Posted : November 29, 2021
Last Update Posted : December 21, 2021
Sponsor:
Collaborator:
Ministry of Health, Singapore
Information provided by (Responsible Party):
Rob M van Dam, National University, 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.

Condition or disease
Health Behavior Diet, Healthy Physical Activity Sedentary Behavior Sleep

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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Observations of Behavioural Risk Factors in Asia (COBRA)
Actual Study Start Date : May 5, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2023



Primary Outcome Measures :
  1. Movement behaviours [ Time Frame: continuously for 9 days. ]
    Movement behaviours (i.e., physical activity, sedentary behaviour, sleep) are measured using a wrist-worn accelerometer.

  2. Glucose concentrations [ Time Frame: in 15-minute intervals over 9 days. ]
    Glucose concentrations are measured using a continuous glucose monitor sensor.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   21 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults in Singapore
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136872


Contacts
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Contact: Rob M van Dam, PhD +6565164980 rob.van.dam@nus.edu.sg
Contact: Falk Müller-Riemenschneider, PhD (65) 6601 3122 falk.m-r@nus.edu.sg

Locations
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Singapore
Saw Swee Hock School of Public Health, National University of Singapore Recruiting
Singapore, Singapore, 117549
Contact: Linda Tan, MPH    +6566014973    linda_tan@nus.edu.sg   
Contact: Sarah M Edney, PhD    +6581321266    sarah.edney@nus.edu.sg   
Principal Investigator: Rob M van Dam, PhD         
Sub-Investigator: Falk Müller-Riemenschneider, PhD         
Sub-Investigator: Sarah M Edney, PhD         
Sponsors and Collaborators
National University, Singapore
Ministry of Health, Singapore
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Responsible Party: Rob M van Dam, Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT05136872    
Other Study ID Numbers: NUS-IRB-2020-50
First Posted: November 29, 2021    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rob M van Dam, National University, Singapore:
health behavior
physical activity
sedentary
sleep
eating behavior
GPS
glycaemic response