Clinical trial NCT00893646: Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers
Official title: Effects of Weight Reduction and Lifestyle Changes on Sleep, Alertness and Cardiometabolic Risk Factors in Overweight Professional Long-distance Drivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Obesity
Keywords: abdominal obesity
weight reduction
diet
exercise training
lifestyle activity
health-related fitness
walking
actigraphy
lifestyle modification
sleep
sleep hygiene
alertness
daytime sleepiness
metabolic syndrome
counselling
health education
truck drivers
bus drivers
randomized controlled trial
Lead sponsor: UKK Institute
Sponsor class: OTHER
Collaborators: name: Academy of Finland
name: Finnish Institute of Occupational Health
name: Vitalmed Research Centre
First posted: 2009-05-06
Enrollment: 113
Sex: MALE
Minimum age (years): 30
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Daytime sleepiness, i.e., being fatigued at work is an important risk factor for traffic accidents involving commercial vehicles. Sleep-related disturbances and daytime fatigue may be partly related to obesity, which is common among truck drivers. This study is a randomised 12-month health-behaviour intervention in obese, male truck-drivers. We hypothesize that lifestyle modification (increased physical activity; decreased energy intake; and improved schedule for sleep), aimed to reduce weight moderately by 10%, improves daytime alertness and quality of sleep, reduces daytime sleepiness, and improves cardiometabolic health and health-related fitness. The primary aim is weight loss. We will recruit 140 participants aged 30-62 years and with abdominal obesity. The participants are randomised into an intervention (INT) and control (CON) group, for 12 months. The INT group gets individual lifestyle counseling monthly. After 12 months, the CON group receives weight-loss counseling for 3 months. Assessments (psychological vigilance test, sleep duration, dietary intake, physical activity, metabolic syndrome, health-related fitness) take place at months 0, 12 and 24. We expect to develop counseling strategies (leading to weight loss through changes in lifestyle) that can be used to improve sleep, alertness and cardiometabolic health in occupational health care.

Eligibility criteria: 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

Primary outcomes:
measure: body weight
timeFrame: 12 months
Secondary outcomes:
measure: sleep duration
timeFrame: 12 months
measure: alertness (ability to stay awake)
timeFrame: 12 months
measure: occurrence of metabolic syndrome
timeFrame: 12 months
measure: health-related fitness
timeFrame: 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Finnish Institute of Occupational Health
city: Helsinki
country: Finland
facility: Vitalmed Research Centre & Sleep Clinic
city: Tampere
country: Finland
facility: UKK Institute for Health Promotion Research
Study officials:
affiliation: UKK Institute for Health Promotion Research
name: Katriina T Kukkonen-Harjula, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puhkala J, Kukkonen-Harjula K, Aittasalo M, Mansikkamaki K, Partinen M, Hublin C, Karmeniemi P, Sallinen M, Olkkonen S, Tokola K, Ojala A, Nygard CH, Fogelholm M. Lifestyle counseling in overweight truck and bus drivers - Effects on dietary patterns and physical activity. Prev Med Rep. 2016 Aug 15;4:435-40. doi: 10.1016/j.pmedr.2016.08.012. eCollection 2016 Dec.