Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT06862427
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-16', 'studyFirstSubmitDate': '2025-03-02', 'studyFirstSubmitQcDate': '2025-03-02', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': '3 to 6 months after the intervention starts', 'description': '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.'}, {'measure': 'Depressive Symptoms', 'timeFrame': 'Before the intervention and 3 to 6 months after the intervention starts', 'description': '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.'}, {'measure': 'Posttraumatic Stress Disorder Symptoms', 'timeFrame': 'Before the intervention and 3 to 6 months after the intervention starts', 'description': '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.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Before the intervention and 3 to 6 months after the intervention starts', 'description': '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.'}, {'measure': 'Smoking Habit', 'timeFrame': 'Before the intervention and 3 to 6 months after the intervention starts', 'description': 'The investigators will ask if the participants had quit or stopped using tobacco in a questionnaire to verify their smoking habits.'}, {'measure': 'Mediterranean Diet Pattern', 'timeFrame': 'Before the intervention and 3 to 6 months after the intervention starts', 'description': '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.'}, {'measure': 'Overall Physical Activity Levels', 'timeFrame': 'Before the intervention and 3 to 6 months after the intervention starts', 'description': '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.'}, {'measure': 'Total weekly hours spent sitting', 'timeFrame': 'Before the intervention and 3 to 6 months after the intervention starts', 'description': 'The investigators will ask the participant with the question "Indicate the total number of hours sitting per week"'}, {'measure': 'Average daily hours of sleep', 'timeFrame': 'Before the intervention and 3 to 6 months after the intervention starts', 'description': '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"'}, {'measure': 'Frequency of siestas per week', 'timeFrame': 'Before the intervention and 3 to 6 months after the intervention starts', 'description': 'The investigators will ask the participant with the question "How many times do you take a nap per week?"'}, {'measure': 'Glycated Hemoglobin', 'timeFrame': '3 to 6 months after the intervention starts', 'description': '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.'}, {'measure': 'Lipid Profile', 'timeFrame': '3 to 6 months after the intervention starts', 'description': '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.'}, {'measure': 'C-reactive protein(CRP)', 'timeFrame': '3 to 6 months after the intervention starts', 'description': '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.'}, {'measure': 'Physical Performance', 'timeFrame': 'In the latter half of 2025', 'description': "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"}], 'secondaryOutcomes': [{'measure': 'NT-proBNP', 'timeFrame': '3 to 6 months after the intervention starts', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health', 'Physical Performance', 'Cardiovascular Health', 'Lifestyle Intervention']}, 'descriptionModule': {'briefSummary': "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:\n\n* Does the Traditional Chinese version of the HLS mobile App improve firefighters' mental and physical health compared to usual care?\n* Can the intervention effectively promote a healthy lifestyle and reduce the risk of chronic non-communicable diseases among firefighters?\n\nResearchers 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.\n\nParticipants will:\n\n* 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.\n* Be randomly assigned to either the intervention group (HLS App) or the control group (usual care).\n* Undergo health and fitness assessments at baseline and at 3 to 6 months post-intervention.\n\nAnticipated outcomes are improvements in mental and physical health among firefighters receiving the intervention compared to the control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Career firefighters who are older than or equal 20 years old\n\nExclusion Criteria:\n\n* Career firefighters who are younger than 20 years old\n* Firefighters who are retired or are volunteer firefighters.'}, 'identificationModule': {'nctId': 'NCT06862427', 'briefTitle': 'A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'A Multi-language Smartphone-based Healthy Lifestyle Intervention for Firefighters: A Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NYCU113176AE'}, 'secondaryIdInfos': [{'id': 'NSTC-111-2314-B-A49A-507-MY3', 'type': 'OTHER_GRANT', 'domain': 'National Science and Technology Council'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Lifestyle APP Intervention (Traditional Chinese Version)', 'interventionNames': ['Behavioral: Healthy Lifestyle Application (Traditional Chinese Version)']}], 'interventions': [{'name': 'Healthy Lifestyle Application (Traditional Chinese Version)', 'type': 'BEHAVIORAL', 'description': 'A firefighter-oriented Healthy Lifestyle Application (Traditional Chinese Version)', 'armGroupLabels': ['Healthy Lifestyle APP Intervention (Traditional Chinese Version)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsiao-Jou Yu', 'role': 'CONTACT', 'email': 's309109008@nycu.edu.tw', 'phone': '+8862-28267000', 'phoneExt': '65109'}, {'name': 'Chen-Yu Huang', 'role': 'CONTACT', 'email': 'cyh.md12@nycu.edu.tw', 'phone': '+8862-28267000', 'phoneExt': '65036'}, {'name': 'Fan-Yun Lan Assistant Professor, MD. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Yang Ming Chiao Tung University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hsiao-Jou Yu', 'role': 'CONTACT', 'email': 's309109008@nycu.edu.tw', 'phone': '+8862-28267000', 'phoneExt': '65109'}, {'name': 'Chen-Yu Huang', 'role': 'CONTACT', 'email': 'cyh.md12@nycu.edu.tw', 'phone': '+8862-28267000', 'phoneExt': '65036'}], 'overallOfficials': [{'name': 'Fan-Yun Lan Assistant Professor, MD. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Yang Ming Chiao Tung University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}