Clinical trial NCT06889792: Prevent Non-communicable Diseases Through Screening and Educating Emergency Department Attendees to Adopt Healthy Lifestyles
Official title: A Proactive Approach to Prevent Non-communicable Diseases Through Screening and Educating Emergency Department Attendees to Adopt Healthy Lifestyles: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non Communicable Diseases
Health-risk Behaviours
Keywords: Health-risk Behaviours
Non Communicable Diseases
Emergency Department
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 1172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: To examine the effectiveness of a general health promotion intervention based on self-determination theory in proactively helping emergency department (ED) attendees to adopt healthy lifestyles.

Hypothesis to be tested: A general health promotion intervention based on self-determination theory will be effective in helping people adopt healthy lifestyles.

Design and subjects: The investigators will conduct a randomised controlled trial involving 1,242 ED attendees from five major acute care hospitals in Hong Kong.

Instruments: A behavioural risk factor questionnaire will be used to identify participants' health risk behaviours and document their blood pressure and body mass index. The EuroQoL 5-Dimension 5-level will be used to assess participants' quality of life.

Interventions: Participants in the intervention group will receive a brief health warning and advice on health-risk behaviours. In addition, participants will be asked about their priority in engaging in healthy lifestyles. Moreover, participants will receive WhatsApp/WeChat messages during the first 6 months as a reminder to adhere to their desired healthy lifestyle and a link to a 1-minute video relevant to their selected healthy lifestyle. Participants in the control group will receive brief advice on adopting healthy lifestyles through regular text messages.

Main outcome measures: The number of healthy lifestyles adopted at 6 months. Data analysis and expected results: SPSS for Windows will be used for quantitative data analysis. A significantly higher proportion of participants in the intervention group will adopt healthy lifestyles and exhibit better quality of life than those in the control group at 6 and 12 months.

Detailed description: Study design An assessor-blinded, multicentre RCT with a two-group between-subjects design will be used following the Consolidated Standards of Reporting Trial.

Setting The proposed project will be conducted at the EDs of five major acute care hospitals in different clusters in Hong Kong.

Recruitment At the EDs The investigators has obtained ethical approval from the institutional review boards of the five hospitals. All potential participants will be approached by emergency nurses before being discharged from the EDs. These nurses will provide potential participants with a leaflet detailing the nature, purpose, design, procedures, and potential benefits and risks of the study. Subsequently, the emergency nurses will refer the potential participants to the RA. Informed written consent will be obtained from all participants. Participants will be assured that their participation will be voluntary, with no prejudice attached to refusal, and that the information provided by them will be kept confidential. A baseline assessment will be performed using questionnaires. Then, participants will be informed that participants will receive a telephone call from an RA within 3 days to evaluate their potential health-risk behaviours and provide them with appropriate health advice to adopt healthy lifestyles. In addition, the participants will be provided 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

Intervention

1. Intervention group Brief intervention via telephone (within 3 days after visiting the ED) The participants will receive a brief intervention using the Ask, Warn, Advise, Refer and Do-it- again (AWARD) model, which was originally developed for primary-care tobacco cessation. This 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 on adopting healthy lifestyles to improve the participant's health; (4) Refer to hotline services, such as those for smoking cessation and alcohol treatment or the nearest district health centre to follow up their health status; and (5) Do it again if participants have not adopted a healthy lifestyle at follow-ups. For the advice step, the RA will ask about the participants' priority in engaging in a desired health-related lifestyle based on their responses in the behavioural risk factor questionnaire. The participants will also be asked to choose a goal that the participants consider most attainable, such as quitting or reducing smoking, consuming more vegetables or less fatty foods or sugary drinks, performing more exercise, or reducing alcohol consumption. Although the participants will be encouraged to adopt aspects of a healthy lifestyle sequentially, the participants will have the option to adopt them simultaneously if the participants feel confident in doing so. Each participant will receive a brief (approximately 5 minutes) individual intervention providing health advice on their selected lifestyle goal. The entire intervention will last approximately 10 minutes and may be extended if necessary.

   At the end of the telephone call, the participant will be informed that the RA will assist them in achieving their health-related goals throughout the study by sending messages via

   WhatsApp/WeChat. Follow-up booster intervention (up to 6 months) During the first 6 months of the proposed project, the RA will send WhatsApp/WeChat messages approximately once a week to remind the participants to adhere to their desired health-related lifestyle. Instant messaging via mobile applications was found to be effective in enhancing treatment compliance. In addition, during the first week, the RA will send participants a link via WhatsApp/WeChat to a 1-minute video developed by the research team comprising content relevant to their selected health-related lifestyle. Four separate 1-minute videos will be compiled, each focusing on a different healthy lifestyle. These videos will indicate the health hazards of continuing this health risk behaviour and the benefits of adopting a healthy lifestyle. Moreover, the RA will encourage the participants to watch the video and ask any questions regarding the video content via WhatsApp/WeChat. One advantage of using videos to deliver instant health advice messages is the use of sound and images, which can elicit emotions, enhance understanding of abstract concepts, and improve the retention of new information through auditory, visual, and verbal stimulation. Moreover, the delivered content can be viewed by the participants at their convenience and own pace.

   Follow-up assessment of behavioural changes at 3, 6, and 12 months The success of the participants in achieving their targeted health-related lifestyle will be assessed through phone calls at 3, 6, and 12 months. If the participants report the successful adoption of a healthy lifestyle, the RA will encourage them to adopt another healthy lifestyle. Then, the RA will provide participants with brief healthcare advice (approximately 5 minutes) and send via WhatsApp/WeChat another 1-minute video focused on their newly chosen and desired health-related lifestyle.
2. Control group Participants will receive a brief telephone intervention based on the AWARD model from the trained RA, similar to that delivered to the intervention group. However, the RA will only advise the participants to adopt a healthy lifestyle. In addition, the RA will send regular SMS messages to participants at a frequency similar to that used for the intervention group. However, these messages will contain only general health advice. In addition, the participants will receive follow-up outcome assessments at the same schedule as that followed in the intervention group.

Eligibility criteria: Inclusion Criteria:

* being aged ≥18 years old Chinese
* being triaged as semi-urgent (level 4) or non-urgent (level 5) and discharged home on the same day after receiving medical attention
* having at least one health risk behaviour (tobacco use, harmful alcohol consumption, unhealthy diet, and physical inactivity)
* owning a smartphone and having an ability to use instant messaging applications (e.g. WhatsApp or WeChat).

Exclusion Criteria:

* having a poor cognitive state or mental illness
* being diagnosed with NCDs and undergoing regular follow-ups in outpatient clinics
* participating in another related study

Primary outcomes:
measure: The composite event rate of adopting at least one of the four healthy lifestyles at 6 months.
timeFrame: from baseline to 6 months
Secondary outcomes:
measure: The composite event rate of adopting at least one of the four healthy lifestyles adopted at 12 months
timeFrame: from baseline to 12 months
measure: Improvement in health-related quality of life at 6 months
timeFrame: from Baseline to 6 months
measure: Improvement in health-related quality of life at 12 months
timeFrame: from baseline to 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Nethersole School of Nursing, The Chinese University of Hong Kong
Study officials:
affiliation: The Nethersole School of Nursing, CUHK
name: Ho Cheung William Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: