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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

National Yang Ming Chiao Tung University

Collaborators

National Cheng-Kung University Hospital

Investigators

  • 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)

March 4, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 2, 2025

First Submitted That Met QC Criteria

March 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 16, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID 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.

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