NCT05790395

Brief Summary

Aim: to prevent NCDs by screening and educating individuals in the community on health-risk behaviours. Specifically, we will use a mobile health and a brief self-determination theory-based intervention in helping individual change their health-risk behaviours. Hypotheses to be tested: compared with those in the control group, the participants in the intervention group will experience significantly greater success in modifying their health-risk behaviours and will have a better health-related quality of life at 12 months follow-up. Objectives

  1. 1.To screen individuals for health-risk behaviours and identify risk factors that may contribute to NCDs
  2. 2.To educate individuals on the importance of engaging in healthy lifestyles
  3. 3.To develop a training programme - "Train the Trainers' Toolkit", with the goal to train student nurses (Years 2 to 5) as health ambassadors to implement the project on a long-term basis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 16, 2023

Last Update Submit

March 17, 2026

Conditions

Keywords

Health-risk BehavioursNon Communicable Diseases

Outcome Measures

Primary Outcomes (1)

  • Abstain from health-risk behaviour

    About 10% of participants will successfully abstain from at least one health-risk behaviour at 12-month follow-up

    12 months

Secondary Outcomes (5)

  • Reduction in health-risk behaviours

    12 months

  • Improvement in health-related quality of life

    12 months

  • Ambassadors' knowledge and skill on providing professional health advice and support to participants about changing their health-risk behaviours

    6 months

  • Improvement in blood pressure

    12 months

  • Improvement in body mass index

    12 months

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 control group participants will also be given a Practical Resource Hub for Healthy Life leaflet containing information on various applications. However, the health ambassadors will simply advise the participants to modify their health-risk behaviours and/or adopt a healthy lifestyle practice. The participants will also receive follow-up for outcome assessments with the same schedule as those in the intervention group.

Other: health-risk behaviors

Interventions

The participants will be simply advised to modify their health-risk behaviours and/or adopt a healthy lifestyle practice. The participants will also receive follow-up for outcome assessments with the same schedule as those in the intervention group.

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:

  • Chinese adults in Kwai Chung Estate:
  • age ≥18 years
  • the presence of at least one health risk behaviour (tobacco use, harmful use of alcohol, unhealthy diet and physical inactivity)
  • able to communicate in Cantonese
  • Nursing students:
  • age ≥18 years
  • Year 2 to 5

You may not qualify if:

  • poor cognitive state or mental illness
  • 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 Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

March 16, 2023

First Posted

March 30, 2023

Study Start

July 13, 2023

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

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.

Shared Documents
STUDY PROTOCOL
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