Mental HealthNCT06862427
A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters
A study testing Healthy Lifestyle Application (Traditional Chinese Version) in people with Mental Health and Physical Performance, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The goal of this cluster randomized controlled trial is to evaluate the effects of a smartphone-based Healthy Lifestyle (HLS) intervention on firefighters' mental and physical health in firefighters in Tainan, Taiwan. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Physical Performance, Cardiovascular Health
- What is being tested?
- Healthy Lifestyle Application (Traditional Chinese Version)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Career firefighters who are older than or equal 20 years old
Who cannot join
- Career firefighters who are younger than 20 years old
- Firefighters who are retired or are volunteer firefighters.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang Ming Chiao Tung University
Taipei, 112
Hsiao-Jou Yu, +8862-28267000 ext. 65109, s309109008@nycu.edu.tw
Chen-Yu Huang, +8862-28267000 ext. 65036, cyh.md12@nycu.edu.tw
About this study
Official title: A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters: A Cluster Randomized Controlled Trial
The goal of this cluster randomized controlled trial is to evaluate the effects of a smartphone-based Healthy Lifestyle (HLS) intervention on firefighters' mental and physical health in firefighters in Tainan, Taiwan. The main questions it aims to answer are:
- Does the Traditional Chinese version of the HLS mobile App improve firefighters' mental and physical health compared to usual care?
- Can the intervention effectively promote a healthy lifestyle and reduce the risk of chronic non-communicable diseases among firefighters?
Read more
Researchers will compare firefighters receiving the smartphone-based HLS intervention to those receiving usual care to determine whether the intervention leads to improved health and fitness outcomes over 3 to 6 months.
Participants will:
- Use the Traditional Chinese version of the HLS mobile App, originally developed at Cambridge Health Alliance, Harvard Medical School, and adapted for firefighters in Taiwan.
- Be randomly assigned to either the intervention group (HLS App) or the control group (usual care).
- Undergo health and fitness assessments at baseline and at 3 to 6 months post-intervention.
Anticipated outcomes are improvements in mental and physical health among firefighters receiving the intervention compared to the control group.
- Being tested
- Healthy Lifestyle Application (Traditional Chinese Version)
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Lifestyle Application (Traditional Chinese Version)Behavioural
A firefighter-oriented Healthy Lifestyle Application (Traditional Chinese Version)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Healthy Lifestyle APP Intervention (Traditional Chinese Version) | Experimental | Not described Receives: Behavioral: Healthy Lifestyle Application (Traditional Chinese Version) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
The participants will maintain a quiet sitting posture for at least five minutes, and the measurement will be taken on a healthy arm without any prior surgery or disease. The blood pressure measuring device will be calibrated and will automatically take three measurements, with a one-minute interval between each. The average blood pressure value will be recorded.
Measured: 3 to 6 months after the intervention starts
Depressive Symptoms
The participants will be asked to complete questionnaires measuring depressive symptoms, which includes the Beck Depression Inventory for Primary Care (BDI-PC) and the Patient Health Questionnaire (PHQ-9). Questions related to self-harm thoughts have been removed from these instruments to eliminate the need for further referrals. Higher scores indicate greater depressive symptoms.
Measured: Before the intervention and 3 to 6 months after the intervention starts
Posttraumatic Stress Disorder Symptoms
The participants will be asked to complete a Posttraumatic Stress Disorder Checklist (PCL-5) questionnaire which measures posttraumatic stress disorder symptoms. Questions related to self-harm thoughts have been removed from these instruments to eliminate the need for further referrals. Higher scores indicate greater depressive symptoms.
Measured: Before the intervention and 3 to 6 months after the intervention starts
Body Mass Index (BMI)
The body mass index (BMI) will be calculated by dividing the weight in kilograms by the square of the height in meters. The height will be self-reported before the intervention and measured to the nearest 0.1 cm while standing upright using a tape measure 3 to 6 months post-intervention, and the weight will be self-reported before the intervention, and measured to the nearest 0.1 kg with a weighing scale 3 to 6 months post-intervention.
Measured: Before the intervention and 3 to 6 months after the intervention starts
Smoking Habit
The investigators will ask if the participants had quit or stopped using tobacco in a questionnaire to verify their smoking habits.
Measured: Before the intervention and 3 to 6 months after the intervention starts
Mediterranean Diet Pattern
The investigators will utilize a Traditional Chinese version of the Mediterranean Diet Score (MDS), consisting of 14 binary questions to determine adherence to the Mediterranean diet pattern.
Measured: Before the intervention and 3 to 6 months after the intervention starts
Overall Physical Activity Levels
The investigators will assess overall physical activity levels over the past 6 months using a Chinese version of a validated physical activity rating (PA-R) questionnaire which our team translated.
Measured: Before the intervention and 3 to 6 months after the intervention starts
Total weekly hours spent sitting
The investigators will ask the participant with the question "Indicate the total number of hours sitting per week"
Measured: Before the intervention and 3 to 6 months after the intervention starts
Average daily hours of sleep
The investigators will ask the participant with the question "Please indicate the total hours of actual sleep in a typical 24-hour period in week"
Measured: Before the intervention and 3 to 6 months after the intervention starts
Frequency of siestas per week
The investigators will ask the participant with the question "How many times do you take a nap per week?"
Measured: Before the intervention and 3 to 6 months after the intervention starts
Glycated Hemoglobin
Biochemical parameters will be measured by the cobas b 101 blood testing system (F. Hoffmann-La Roche AG, Basel, Switzerland) with the participants fingertip blood after a 8-hour fasting.
Measured: 3 to 6 months after the intervention starts
Lipid Profile
Biochemical parameters will be measured by the cobas b 101 blood testing system (F. Hoffmann-La Roche AG, Basel, Switzerland) with the participants fingertip blood after a 8-hour fasting.
Measured: 3 to 6 months after the intervention starts
C-reactive protein(CRP)
Biochemical parameters will be measured by the cobas b 101 blood testing system (F. Hoffmann-La Roche AG, Basel, Switzerland) with the participants fingertip blood after a 8-hour fasting.
Measured: 3 to 6 months after the intervention starts
Physical Performance
The participants will provide their semi-annual evaluation reports, including performance metrics in standing long jump, overhead back toss, deadlift, cliffhanger pull-up, 6-meter out-and-back run, farmer's walk, and 1,500-meter run
Measured: In the latter half of 2025
Secondary outcomes (1)
NT-proBNP
Biochemical parameters will be measured by the Cobas h 232 blood testing system (F. Hoffmann-La Roche AG, Basel, Switzerland) with the fingertip blood of participants with hypertension.
Measured: 3 to 6 months after the intervention starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start4 Mar 2025
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng-Kung University Hospital
- Responsible party
- Sponsor
- Investigators
- Fan-Yun Lan Assistant Professor, MD. Ph.D., Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862427
- Sponsor's protocol ID
- NYCU113176AE
- Other IDs
- NSTC-111-2314-B-A49A-507-MY3
- Status last verified
- Feb 2025
- First submitted
- 2 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06862427
- Acronym / sponsor ID
- NYCU113176AE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- National Cheng-Kung University Hospital
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this cluster randomized controlled trial is to evaluate the effects of a smartphone-based Healthy Lifestyle (HLS) intervention on firefighters' mental and physical health in firefighters in Tainan, Taiwan. The main questions it aims to answer are:
- Does the Traditional Chinese version of the HLS mobile App improve firefighters' mental and physical health compared to usual care?
- Can the intervention effectively promote a healthy lifestyle and reduce the risk of chronic non-communicable diseases among firefighters?
Researchers will compare firefighters receiving the smartphone-based HLS intervention to those receiving usual care to determine whether the intervention leads to improved health and fitness outcomes over 3 to 6 months.
Participants will:
- Use the Traditional Chinese version of the HLS mobile App, originally developed at Cambridge Health Alliance, Harvard Medical School, and adapted for firefighters in Taiwan.
- Be randomly assigned to either the intervention group (HLS App) or the control group (usual care).
- Undergo health and fitness assessments at baseline and at 3 to 6 months post-intervention.
Anticipated outcomes are improvements in mental and physical health among firefighters receiving the intervention compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Healthy Lifestyle APP Intervention (Traditional Chinese Version) | Experimental | Behavioral: Healthy Lifestyle Application (Traditional Chinese Version) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Career firefighters who are older than or equal 20 years old
Key exclusion criteria (2 listed)
- Career firefighters who are younger than 20 years old
- Firefighters who are retired or are volunteer firefighters.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Lifestyle Application (Traditional Chinese Version)A firefighter-oriented Healthy Lifestyle Application (Traditional Chinese Version) | Behavioural | Healthy Lifestyle APP Intervention (Traditional Chinese Version) |
Primary outcome
Blood Pressure
Time frame: 3 to 6 months after the intervention starts
The participants will maintain a quiet sitting posture for at least five minutes, and the measurement will be taken on a healthy arm without any prior surgery or disease. The blood pressure measuring device will be calibrated and will automatically take three measurements, with a one-minute interval between each. The average blood pressure value will be recorded.
Depressive Symptoms
Time frame: Before the intervention and 3 to 6 months after the intervention starts
The participants will be asked to complete questionnaires measuring depressive symptoms, which includes the Beck Depression Inventory for Primary Care (BDI-PC) and the Patient Health Questionnaire (PHQ-9). Questions related to self-harm thoughts have been removed from these instruments to eliminate the need for further referrals. Higher scores indicate greater depressive symptoms.
Posttraumatic Stress Disorder Symptoms
Time frame: Before the intervention and 3 to 6 months after the intervention starts
The participants will be asked to complete a Posttraumatic Stress Disorder Checklist (PCL-5) questionnaire which measures posttraumatic stress disorder symptoms. Questions related to self-harm thoughts have been removed from these instruments to eliminate the need for further referrals. Higher scores indicate greater depressive symptoms.
Body Mass Index (BMI)
Time frame: Before the intervention and 3 to 6 months after the intervention starts
The body mass index (BMI) will be calculated by dividing the weight in kilograms by the square of the height in meters. The height will be self-reported before the intervention and measured to the nearest 0.1 cm while standing upright using a tape measure 3 to 6 months post-intervention, and the weight will be self-reported before the intervention, and measured to the nearest 0.1 kg with a weighing scale 3 to 6 months post-intervention.
Smoking Habit
Time frame: Before the intervention and 3 to 6 months after the intervention starts
The investigators will ask if the participants had quit or stopped using tobacco in a questionnaire to verify their smoking habits.
Mediterranean Diet Pattern
Time frame: Before the intervention and 3 to 6 months after the intervention starts
The investigators will utilize a Traditional Chinese version of the Mediterranean Diet Score (MDS), consisting of 14 binary questions to determine adherence to the Mediterranean diet pattern.
Overall Physical Activity Levels
Time frame: Before the intervention and 3 to 6 months after the intervention starts
The investigators will assess overall physical activity levels over the past 6 months using a Chinese version of a validated physical activity rating (PA-R) questionnaire which our team translated.
Total weekly hours spent sitting
Time frame: Before the intervention and 3 to 6 months after the intervention starts
The investigators will ask the participant with the question "Indicate the total number of hours sitting per week"
Average daily hours of sleep
Time frame: Before the intervention and 3 to 6 months after the intervention starts
The investigators will ask the participant with the question "Please indicate the total hours of actual sleep in a typical 24-hour period in week"
Frequency of siestas per week
Time frame: Before the intervention and 3 to 6 months after the intervention starts
The investigators will ask the participant with the question "How many times do you take a nap per week?"
Glycated Hemoglobin
Time frame: 3 to 6 months after the intervention starts
Biochemical parameters will be measured by the cobas b 101 blood testing system (F. Hoffmann-La Roche AG, Basel, Switzerland) with the participants fingertip blood after a 8-hour fasting.
Lipid Profile
Time frame: 3 to 6 months after the intervention starts
Biochemical parameters will be measured by the cobas b 101 blood testing system (F. Hoffmann-La Roche AG, Basel, Switzerland) with the participants fingertip blood after a 8-hour fasting.
C-reactive protein(CRP)
Time frame: 3 to 6 months after the intervention starts
Biochemical parameters will be measured by the cobas b 101 blood testing system (F. Hoffmann-La Roche AG, Basel, Switzerland) with the participants fingertip blood after a 8-hour fasting.
Physical Performance
Time frame: In the latter half of 2025
The participants will provide their semi-annual evaluation reports, including performance metrics in standing long jump, overhead back toss, deadlift, cliffhanger pull-up, 6-meter out-and-back run, farmer's walk, and 1,500-meter run
1 secondary outcome
NT-proBNP
Time frame: 3 to 6 months after the intervention starts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fan-Yun Lan Assistant Professor, MD. Ph.D. principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyle Application (Traditional Chinese Version) in people with Mental Health and Physical Performance, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiao-Jou Yu (+8862-28267000 ext. 65109, s309109008@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 3 to 6 months after the intervention starts). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.