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临床试验/NCT06862427
NCT06862427招募中不适用

A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters: A Cluster Randomized Controlled Trial

National Yang Ming Chiao Tung University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Blood Pressure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Control

No Intervention

Healthy Lifestyle APP Intervention (Traditional Chinese Version)

Experimental

干预措施: Healthy Lifestyle Application (Traditional Chinese Version) (Behavioral)

结局指标

主要结局

Blood Pressure

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

次要结局

  • NT-proBNP(3 to 6 months after the intervention starts)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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