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Completed

NCT Number: NCT05136872

Continuous Observations of Behavioural Risk Factors in Asia (COBRA)

The aim of this study is to advance understanding of behavioural risk factors for cardiovascular disease and type 2 diabetes in Singapore.

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Key information

Conditions

Health Behavior Behavior Behavior, Animal Diet, Healthy Feeding Behavior Motor Activity Physical Activity Sedentary Behavior Sleep

Age range

21 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Singapore, 117549

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Collaborators

  • Ministry of Health, Singapore

Registry information

Acronym: COBRA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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