The Chinese University of Hong Kong
Hong Kong
NCT Number: NCT05790395
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Hong Kong
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:
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.
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Chinese adults in Kwai Chung Estate:
Nursing students:
Exclusion criteria
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.
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.
Time frame: 12 months
About 10% of participants will successfully abstain from at least one health-risk behaviour at 12-month follow-up
Time frame: 12 months
Reduction in health-risk behaviours (≥ 50% reduction from baseline) at 12-month follow-up
Time frame: 12 months
Improvement in health-related quality of life at 12-month follow-up compare to baseline using questionnaires
Time frame: 6 months
Improvement of ambassadors' knowledge and skill on providing professional health advice and support to participants about changing their health-risk behaviours by comparing pre-, post-training and 6-month evaluation questionnaires.
Time frame: 12 months
Improvement in blood pressure at 12-month follow-up compare to baseline
Time frame: 12 months
Improvements in body mass index at 12-month follow-up compare to baseline
Chinese University of Hong Kong
Other
Prevention of Non-communicable Diseases Through Screening and Educating Individuals on Health-risk Behaviours in the Community
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.
Published trials that share one or more normalized conditions with this study.
NCT06077565
Disease Attributes, Emergencies
Hong Kong
View Trial DetailsNCT05680519
Disease Attributes, Emergencies
Hong Kong
View Trial DetailsNCT07597434
Disease Attributes, Health-risk Behaviours
Hong Kong
View Trial DetailsNCT06889792
Disease Attributes, Emergencies
Hong Kong
View Trial Details