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NCT Number: NCT00893646

Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers

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.

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Key information

Conditions

Abdominal Obesity Adherence Interventions Behavior Body Weight Body Weight Changes Disorders of Excessive Somnolence Dyssomnias Glucose Metabolism Disorders Health Behavior Health Education Hyperinsulinism Insulin Resistance Medication Adherence Mental Disorders Metabolic Diseases Metabolic Syndrome Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Sleep Disorders, Intrinsic Sleep Hygiene Sleep Wake Disorders Treatment Adherence and Compliance Weight Loss

Age range

30 year–62 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Finnish Institute of Occupational Health, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Loss Counseling

Behavioral

individual monthly lifestyle counseling, face-to-face (6 times, each 45 min) and by telephone (7 times, each 30 min), on how to decrease energy intake and change eating habits to improve quality of dietary fat and carbohydrate, how to increase daily walking steps; and how to improve sleep quality (sleep hygienic tips)

Other names: lifestyle counseling

Primary outcomes

  1. body weight

    Time frame: 12 months

Secondary outcomes

  1. sleep duration

    Time frame: 12 months

  2. alertness (ability to stay awake)

    Time frame: 12 months

  3. occurrence of metabolic syndrome

    Time frame: 12 months

  4. health-related fitness

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

UKK Institute

Other

Collaborators

  • Academy of Finland
  • Finnish Institute of Occupational Health
  • Vitalmed Research Centre

Registry information

Official study title

Effects of Weight Reduction and Lifestyle Changes on Sleep, Alertness and Cardiometabolic Risk Factors in Overweight Professional Long-distance Drivers

Acronym: SF-Truck

Important dates

Study start
2009
Primary completion
2012
Study completion
2015
First posted
May 6, 2009
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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