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

NCT06862427 | Recruiting

• 2 other identifiers: NYCU113176AENSTC-111-2314-B-A49A-507-MY3
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mental Health; Physical Performance; Cardiovascular Health; Lifestyle Intervention

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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"

  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"

  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?"

  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.

  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.

  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.

  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

  In the latter half of 2025

Secondary Outcomes (1)

• NT-proBNP

  3 to 6 months after the intervention starts

Study Arms (2)

Control

NO INTERVENTION

Healthy Lifestyle APP Intervention (Traditional Chinese Version)

EXPERIMENTAL

Behavioral: Healthy Lifestyle Application (Traditional Chinese Version)

Interventions

Healthy Lifestyle Application (Traditional Chinese Version) BEHAVIORAL

A firefighter-oriented Healthy Lifestyle Application (Traditional Chinese Version)

Healthy Lifestyle APP Intervention (Traditional Chinese Version)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead
• National Cheng-Kung University Hospital: collaborator

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Fan-Yun Lan Assistant Professor, MD. Ph.D.

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiao-Jou Yu

CONTACT

+8862-28267000; s309109008@nycu.edu.tw

Chen-Yu Huang

CONTACT

+8862-28267000; cyh.md12@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 6, 2025
• Study Start: March 4, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-02

Locations

TW (1)