Continuous Observations of Behavioural Risk Factors in Asia (COBRA)

Sponsor
National University, Singapore (Other)
Overall Status
Recruiting
CT.gov ID
NCT05136872
Collaborator
Ministry of Health, Singapore (Other)
1,500
1
25.9
58

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated 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
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Movement behaviours [continuously for 9 days.]

      Movement behaviours (i.e., physical activity, sedentary behaviour, sleep) are measured using a wrist-worn accelerometer.

    2. Glucose concentrations [in 15-minute intervals over 9 days.]

      Glucose concentrations are measured using a continuous glucose monitor sensor.

    3. 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.

    4. 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.

    5. 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.

    Secondary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saw Swee Hock School of Public Health, National University of Singapore Singapore Singapore 117549

    Sponsors and Collaborators

    • National University, Singapore
    • Ministry of Health, Singapore

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rob M van Dam, Professor, National University, Singapore
    ClinicalTrials.gov Identifier:
    NCT05136872
    Other Study ID Numbers:
    • NUS-IRB-2020-50
    First Posted:
    Nov 29, 2021
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Professor, National University, Singapore

    Study Results

    No Results Posted as of Dec 21, 2021