NCT05136872

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3.3 years

First QC Date

November 14, 2021

Last Update Submit

September 11, 2024

Conditions

Keywords

health behaviorphysical activitysedentarysleepeating behaviorGPSglycaemic response

Outcome Measures

Primary Outcomes (5)

  • Movement behaviours

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

    continuously for 9 days.

  • Glucose concentrations

    Glucose concentrations are measured using a continuous glucose monitor sensor.

    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.

    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.

    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.

    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

    Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.

  • Self-reported fatigue

    Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.

  • 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 hunger

    Data will be collected 6 times per day for 9 days, and repeated at the 6-month follow-up.

Eligibility Criteria

Age21 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults in Singapore

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Singapore, 117549, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 35795338BACKGROUND

MeSH Terms

Conditions

Health BehaviorMotor ActivitySedentary BehaviorFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Study Officials

  • Rob M van Dam, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 14, 2021

First Posted

November 29, 2021

Study Start

May 5, 2021

Primary Completion

August 26, 2024

Study Completion

August 26, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations