Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers (NCT00893646) | Clinical Trial Compass
CompletedNot Applicable
Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers
Finland113 participantsStarted 2009-05
Plain-language summary
The study is a year-long health-behaviour intervention in obese, male truck-drivers to lose weight moderately by 10%, using monthly individual counseling. The investigators hypothesize that lifestyle modification (increased physical activity, changes in eating habits, and improved schedule for sleep) through weight loss improves daytime alertness and quality of sleep, reduces daytime sleepiness, and improves cardiovascular risk factors and health-related fitness.
Who can participate
Age range
30 Years – 62 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* male
* age 30-62 years
* long-distance truck or bus driver (on average continuous driving for at least one hour daily outside the city center)
* irregular working hours (on average at least once weekly between 0600-1800 hours)
* waist circumference at least 100 cm
* sedentary: leisure physical activity no more than 30 minutes twice weekly at moderate intensity, and no medical contraindications to increase physical activity
Exclusion Criteria:
* no moderate or severe sleep apnoea with CPAP therapy or with previous surgical operations in the neck area (e.g., UPPP)
* no regular use of sleeping medicines (on average not more often than once weekly)
* no severe sleep disorder
* greatly elevated resting blood pressure (\> 180/120 mmHg)
* no diabetes mellitus with medication
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.