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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Academy of Finland
Finnish Institute of Occupational Health
Vitalmed Research Centre & Sleep Clinic
Information provided by (Responsible Party):
Katriina Kukkonen-Harjula, UKK Institute
ClinicalTrials.gov Identifier:
NCT00893646
First received: May 4, 2009
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Abdominal Obesity
Behavioral: weight loss counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Weight Reduction and Lifestyle Changes on Sleep, Alertness and Cardiometabolic Risk Factors in Overweight Professional Long-distance Drivers

Resource links provided by NLM:


Further study details as provided by UKK Institute:

Primary Outcome Measures:
  • body weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sleep duration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • alertness (ability to stay awake) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • occurrence of metabolic syndrome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • health-related fitness [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: May 2009
Estimated Study Completion Date: January 2015
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: weight loss counseling Behavioral: weight loss counseling
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 Name: lifestyle counseling
No Intervention: control

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

Ages Eligible for Study:   30 Years to 62 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893646

Locations
Finland
Finnish Institute of Occupational Health
Helsinki, Finland, FI-00250
Vitalmed Research Centre & Sleep Clinic
Helsinki, Finland, FI-00420
UKK Institute for Health Promotion Research
Tampere, Finland, FI-33500
Sponsors and Collaborators
UKK Institute
Academy of Finland
Finnish Institute of Occupational Health
Vitalmed Research Centre & Sleep Clinic
Investigators
Principal Investigator: Katriina T Kukkonen-Harjula, MD, Ph.D. UKK Institute for Health Promotion Research
  More Information

Additional Information:
No publications provided

Responsible Party: Katriina Kukkonen-Harjula, senior researcher, UKK Institute
ClinicalTrials.gov Identifier: NCT00893646     History of Changes
Other Study ID Numbers: R09025, SA124344
Study First Received: May 4, 2009
Last Updated: December 13, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by UKK Institute:
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

Additional relevant MeSH terms:
Obesity
Obesity, Abdominal
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014