NCT05680519

Brief Summary

Aim: To determine the feasibility and potential efficacy of a proactive approach using a brief self-determination theory-based intervention to help people attending the ED modify their health-risk behaviours and lead healthier lives. Objectives

  1. 1.To assess the recruitment, participation and retention rates of targeted participants in an emergency department
  2. 2.To ascertain the feasibility of screening, recruiting and educating people to change health-risk behaviours in the emergency department

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

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

First Submitted

Initial submission to the registry

December 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

December 2, 2022

Last Update Submit

March 17, 2026

Conditions

Keywords

Health-risk BehavioursNon Communicable DiseasesEmergency Department

Outcome Measures

Primary Outcomes (4)

  • Feasibility of the study

    Assess the feasibility of the study through the recruitment/participation rate

    at baseline

  • Feasibility of the study

    Assess the feasibility of the study through the participation/retention rate

    3 months

  • Feasibility of the study

    Assess the feasibility of the study through the participation/retention rate

    6 months

  • Feasibility of the study

    Assess the feasibility of the study through the participation/retention rate

    12 months

Secondary Outcomes (12)

  • Change of smoking consumption

    3 months

  • Change of smoking consumption

    6 months

  • Change of smoking consumption

    12 months

  • Change of alcohol consumption

    3 months

  • Change of alcohol consumption

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

The participants will also be given a Practical Resource Hub for Healthy Life leaflet containing information on various applications. The participants will receive a brief telephone intervention using the Ask, Warn, Advise, Refer and Do-it-again (AWARD) model. For the advice step, the research assistant will ask about the priority the participants place on engagement in desirable health-related lifestyle practices identified in the completed behavioural risk factor survey. The participants will also be asked to choose the goal that they consider easiest to achieve, such as quitting or reducing smoking, consuming more vegetables or less fatty foods or sugary drinks, performing more exercise or reducing alcohol consumption. The participants will be encouraged to quit health-risk behaviours (or adopt a healthy lifestyle) sequentially, but they will also be able to choose to quit them simultaneously if they are confident in doing so.

Other: theory of planned behaviour, foot-in-the-door technique, and self-determination theory intervention

Control group

PLACEBO COMPARATOR

The participants will also be given a Practical Resource Hub for Healthy Life leaflet containing information on various applications. The control group participants will receive a brief telephone intervention based on the AWARD model and delivered by the trained research assistant, similar to that delivered to the intervention group. However, the research assistant will simply advise the participants to modify their health-risk behaviours and/or adopt a healthy lifestyle practice. In addition, the research assistant will send regular SMS messages to the participants at a similar frequency to the intervention group, but these messages will contain only general health advice. The participants will also receive follow-up for outcome assessments with the same schedule as those in the intervention group.

Other: Control group

Interventions

The participants will be simply advised to modify their health-risk behaviours and/or adopt a healthy lifestyle practice. In addition, the research assistant will send regular SMS messages to the participants at a similar frequency to the intervention group, but these messages will contain only general health advice.

Control group

The participants will also be asked to choose the goal that they consider easiest to achieve and encouraged to quit health-risk behaviours. The research assistant will assist in achieving the participant's health-related goals by sending WhatsApp/WeChat messages or via telephone calls once per week for the first 6 months.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) age ≥18 years,
  • (2) triage as semi-urgent (level 4) or non-urgent (level 5), and
  • (3) the presence of at least one health risk behaviour (tobacco use, harmful use of alcohol, unhealthy diet and physical inactivity)

You may not qualify if:

  • (1) poor cognitive state or mental illness and
  • (2) participation in another related study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Noncommunicable DiseasesEmergencies

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ho Cheung William Li, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2022

First Posted

January 11, 2023

Study Start

February 20, 2023

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The relevant anonymized patient level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.

Time Frame
After the project has been completed and the results of the project has been published
Access Criteria
Request could be sent to Principal Investigator (williamli@cuhk.edu.hk)

Locations