A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters

March 16, 2025 updated by: National Yang Ming Chiao Tung University

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?

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • National Yang Ming Chiao Tung University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fan-Yun Lan Assistant Professor, MD. Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Career firefighters who are older than or equal 20 years old

Exclusion Criteria:

  • Career firefighters who are younger than 20 years old
  • Firefighters who are retired or are volunteer firefighters.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: Healthy Lifestyle APP Intervention (Traditional Chinese Version)
Behavioral: Healthy Lifestyle Application (Traditional Chinese Version)
A firefighter-oriented Healthy Lifestyle Application (Traditional Chinese Version)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 to 6 months after the intervention starts
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.
Before the intervention and 3 to 6 months after the intervention starts
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.
Before the intervention and 3 to 6 months after the intervention starts
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.
Before the intervention and 3 to 6 months after the intervention starts
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.
3 to 6 months after the intervention starts
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.
3 to 6 months after the intervention starts
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.
3 to 6 months after the intervention starts
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
In the latter half of 2025
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.
Before the intervention and 3 to 6 months after the intervention starts
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.
Before the intervention and 3 to 6 months after the intervention starts
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.
Before the intervention and 3 to 6 months after the intervention starts
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"
Before the intervention and 3 to 6 months after the intervention starts
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"
Before the intervention and 3 to 6 months after the intervention starts
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?"
Before the intervention and 3 to 6 months after the intervention starts

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NT-proBNP
Time Frame: 3 to 6 months after the intervention starts
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.
3 to 6 months after the intervention starts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming Chiao Tung University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cheng-Kung University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fan-Yun Lan Assistant Professor, MD. Ph.D., National Yang Ming Chiao Tung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NYCU113176AE
  • NSTC-111-2314-B-A49A-507-MY3 (Other Grant/Funding Number: National Science and Technology Council)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings