UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063165 |
|---|---|
| Receipt number | R000070083 |
| Scientific Title | Association between cardiometabolic risk factors and work-rest conditions in truck drivers: A preliminary survey targeting small-to-medium-sized transport companies |
| Date of disclosure of the study information | 2026/10/03 |
| Last modified on | 2026/10/03 18:07:12 |
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Basic information
Public title
Survey on the association between cardiometabolic risk and work-rest conditions in truck drivers
Acronym
Truck Driver Health and Work Survey
Scientific Title
Association between cardiometabolic risk factors and work-rest conditions in truck drivers: A preliminary survey targeting small-to-medium-sized transport companies
Scientific Title:Acronym
CMRFs-Truck Driver Survey
Region
| Japan |
Condition
Condition
Cardiometabolic risk factors (obesity, hypertension, dyslipidemia, diabetes mellitus)
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to cross-sectionally examine the association between objectively measured cardiometabolic risk factors (CMRFs) from health examination data (BMI, blood pressure, blood glucose, lipid levels, etc.) and work-rest conditions (driving patterns, frequency of night driving, sleep duration, days off activities, etc.) collected via a web-based questionnaire among truck drivers employed at small-to-medium-sized transport companies. Specifically, the study tests whether the degree of work burden including night driving and inadequate rest conditions are significantly associated with objective CMRFs (Hypothesis 1), and whether inadequate rest conditions independently contribute to elevated objective CMRFs beyond subjective fatigue accumulation (Hypothesis 2).
Basic objectives2
Others
Basic objectives -Others
Exploratory investigation of the association between cardiometabolic risk factor status and work-rest conditions
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Objectively measured cardiometabolic risk factors (CMRFs): (1) Body composition/obesity: BMI (obesity defined as >=25) and waist circumference (2) Blood pressure: systolic (SBP) and diastolic (DBP); hypertension defined as SBP>=140mmHg or DBP>=90mmHg (3) Lipid metabolism: total cholesterol, LDL-C, HDL-C, triglycerides (4) Glucose metabolism: blood glucose and HbA1c
Key secondary outcomes
Work-rest conditions collected via web questionnaire: (1) Driving patterns (daytime local, nighttime/early morning local, long-distance 1-night, long-distance 2+ nights) (2) Frequency of night/early morning shifts (3) Sleep duration and quality on work days and days off (4) Perceived work burden (night driving, loading, etc.) (5) Fatigue status (self-assessed overwork) (6) Health-related behaviors (smoking, alcohol, exercise, diet)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Currently employed as a truck driver at one of 3 small-to-medium-sized transport companies that receive periodic health examinations at the International University of Health and Welfare (IUHW) Narita Hospital Preventive Medicine Center 2. Has undergone a periodic health examination at the Center within the past year, with available CMRFs data 3. Able to provide written (electronic) informed consent voluntarily 4. Aged 20-65 years at the time of consent 5. Primary job duty is commercial truck driving
Key exclusion criteria
1. Withdrew or unable to provide consent 2. Not currently engaged in driving duties due to long-term leave (>=3 months sick leave, parental leave, etc.) at the time of questionnaire completion 3. Missing essential data from health examination records or web questionnaire responses 4. Judged by the principal investigator as unable to self-complete the web questionnaire or participate in the study due to severe psychiatric illness or cognitive impairment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinta |
| Middle name | |
| Last name | Takeuchi |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, Narita School of Health Sciences
Zip code
286-8686
Address
4-3 Kozunomori, Narita, Chiba 286-8686, Japan
TEL
0476-20-7746
shinta.t@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shinta |
| Middle name | |
| Last name | Takeuchi |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, Narita School of Health Sciences
Zip code
286-8686
Address
4-3 Kozunomori, Narita, Chiba 286-8686, Japan
TEL
0476-20-7746
Homepage URL
shinta.t@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Aioi Nissay Dowa Insurance Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Ethics Review Committee
Address
4-3 Kozunomori, Narita, Chiba 286-8686, Japan
Tel
0476-20-7708
rinri_md@iuhw.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
25-CC-034
Org. issuing International ID_1
International University of Health and Welfare Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
42
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional association study targeting truck drivers at small-to-medium-sized transport companies. The study examines the association between objectively measured CMRFs (BMI, blood pressure, lipids, blood glucose) from existing health examination data and work-rest conditions (driving patterns, night driving frequency, sleep duration, days off activities) collected via a web-based questionnaire. Statistical methods include multiple logistic regression (CMRFs presence/absence as outcome), multiple linear regression (CMRFs continuous values as outcome), hierarchical regression (testing independent contribution of rest conditions), and nonparametric tests (group comparisons). Age, alcohol consumption, and smoking are adjusted as covariates. IBM SPSS Statistics is used with a two-sided significance level of 5%.
Management information
Registered date
| 2026 | Year | 10 | Month | 03 | Day |
Last modified on
| 2026 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070083
