Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05790395 |
| Other study ID # |
NTEC-2023-081 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 13, 2023 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
August 2023 |
| Source |
Chinese University of Hong Kong |
| Contact |
Ho Cheung William Li, PhD |
| Phone |
39430889 |
| Email |
williamli[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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. To screen individuals for health-risk behaviours and identify risk factors that may
contribute to NCDs
2. To educate individuals on the importance of engaging in healthy lifestyles
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.
Description:
Setting:
The project will be carried out in Kwai Chung Estate, one of the largest public housing
estates with many low-income families in Hong Kong.
The project consists of four phases.
Phase I:
To invite 30 university nursing students (Year 2 to 5) to become health ambassadors for the
prevention of NCDs in the community.
Phase II:
To develop a training curriculum and conduct a one-day workshop for university nursing
students to equip them with knowledge and skills to perform screening for individuals'
health-risk behaviours and educating them to adopt healthy lifestyles.
Phase III:
To recruit 300 individuals (150 each in intervention and control groups) in Kwai Chung Estate
with the aims of screening and educating health-risk behaviours and identifying risk factors
that may contribute to NCDs. Activities will include putting up posters and organizing a
health carnival with health education talks and health checks.
Asbury Methodist Social Service will help:
- Promotion activities (promotional posters detailing the nature and purpose of the health
promotion project will be posted on notice boards at The Asbury Methodist Social Service
Centres to identify potential participants)
- Provide venues for health talks and health checks for subject recruitment
- Co-organize a health carnival for subject recruitment
Phase IV:
To implement a mobile health brief intervention based on self-determination theory in helping
individual change their health-risk behaviours.
Intervention:
Participants will first assess for risky behaviours using a behavioural risk factor survey.
In addition, their blood pressure, body weight, height, body mass index (BMI), and
health-related quality of life will be assessed.
1. Intervention group Participants will then receive a brief intervention by trained health
ambassadors using the Ask, Warn, Advise, Refer and Do-it-again (AWARD) model at the time
of recruitment. The brief intervention includes the following steps: (1) ask about and
assess health-risk behaviours; (2) warn about the high morbidity and mortality risks
associated with health-risk behaviours; (3) advise to adopt healthy lifestyle practices
to benefit the health; (4) refer to hotline services on request, such as smoking
cessation, alcohol treatment services and district health centres; and (5) do it again
if they report failure to change a health-risk behaviour at follow-up. The health
ambassadors 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. Each participant will then
receive a brief (approximately 10 minutes), individual intervention with health advice
about the selected health-related lifestyle practice. The participants will also be
given a Practical Resource Hub for Healthy Life leaflet containing information on
various applications, including (i) 'Move Your Body', (ii) 'Eat Healthy', (iii) 'Live
Alcohol Free', and (iv) 'Stay Away from Tobacco', which were developed by the Hong Kong
Department of Health.
For the first 6 months of the project period, the health ambassadors will deliver
WhatsApp/WeChat messages about once per week as a reminder for the participants to
adhere to their desirable health-related lifestyle practice. If a participant does not
own a smartphone or is unable to receive WhatsApp/WeChat messages (uncommon in Hong
Kong), the health ambassadors will make a telephone call, instead of sending a message.
Participants will be assessed to determine their success in changing their targeted
health-related lifestyle practice at 3, 6, and 12 months.
2. Control group 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.
Subject recruitment The investigators will obtain ethical approval from the Joint CUHK-NTEC
CREC. Potential participants will be assessed for eligibility, and the purpose, design,
procedures, and potential benefits and risks of the study will be explained to them. Informed
written consent will then be sought. All subjects will be assured that their participation
will be voluntary, with no prejudice attached to refusal, and that the information they
provide will be kept confidential. The researcher is responsible for its safekeeping and the
only one who would have access to the raw data or study record during or after the study.
After the period of storage, all raw data and records will be destroyed.
The proposed study will adhere to the Declaration of Helsinki - Ethical Principles for
Medical Research Involving Human Subjects.
Randomization and allocation concealment Stratified block randomisation with 1:1 allocation
will be conducted using varying block sizes of 2-4 to achieve an appropriate balance of
participant numbers between the two groups and to optimise allocation concealment.
Randomization will be performed by the research assistant, who will unseal a serially
labelled, opaque envelope containing a card to indicate the group allocation. To ensure
allocation concealment, the random numbers used for allocation will be computer-generated by
a co-investigator before subject recruitment.
Data processing and analysis
Instruments:
A behavioural risk-factor survey will be used to collect the eligible participants'
demographic and clinical data and information about their health-risk behaviours at baseline
and at 3, 6, and 12 months. This questionnaire is adapted from a questionnaire used by the
Hong Kong Department of Health and was used to investigate multiple health-risk behaviours
among Chinese adults in Hong Kong in 2021.
The EuroQoL 5-Dimension 5-level (EQ-5D-5L) will be used to measure subjects' health-related
quality of life at baseline, 6 months, and 12 months. The psychometric properties of the
Chinese version of the EQ-5D-5L have been tested, and the findings indicate that this tool is
a valid, reliable, and sensitive measure of health-related quality of life. A
Chinese-specific EQ-5D-5L value set will enable the estimation of health utility scores
applicable to the Chinese population and quality-adjusted life-years (QALY) for
cost-effectiveness analysis (CEA).
SPSS for Windows (SPSS version 26.0; IBM Corp., Armonk, NY, USA) will be used for the
quantitative data analysis. Descriptive statistics will be used to calculate the mean,
standard deviation, and frequency of the demographic and health-risk behaviour data. The
analysis including the main effect, i.e., behavioural changes at 12 months in the
intervention group versus those in the control group, will be performed using a chi-square
test or Fisher's exact test.
