Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers (SF-Truck)
Primary Purpose
Abdominal Obesity
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
weight loss counseling
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity focused on measuring 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
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
Sites / Locations
- Finnish Institute of Occupational Health
- Vitalmed Research Centre & Sleep Clinic
- UKK Institute for Health Promotion Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
weight loss counseling
control
Arm Description
individual monthly counseling on diet, physical activity and sleep
no lifestyle advice, yearly assessments
Outcomes
Primary Outcome Measures
body weight
Secondary Outcome Measures
sleep duration
alertness (ability to stay awake)
occurrence of metabolic syndrome
health-related fitness
Full Information
NCT ID
NCT00893646
First Posted
May 4, 2009
Last Updated
May 29, 2015
Sponsor
UKK Institute
Collaborators
Academy of Finland, Finnish Institute of Occupational Health, Vitalmed Research Centre
1. Study Identification
Unique Protocol Identification Number
NCT00893646
Brief Title
Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers
Acronym
SF-Truck
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UKK Institute
Collaborators
Academy of Finland, Finnish Institute of Occupational Health, Vitalmed Research Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
weight loss counseling
Arm Type
Experimental
Arm Description
individual monthly counseling on diet, physical activity and sleep
Arm Title
control
Arm Type
No Intervention
Arm Description
no lifestyle advice, yearly assessments
Intervention Type
Behavioral
Intervention Name(s)
weight loss counseling
Other Intervention Name(s)
lifestyle counseling
Intervention Description
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)
Primary Outcome Measure Information:
Title
body weight
Time Frame
12 months
Secondary Outcome Measure Information:
Title
sleep duration
Time Frame
12 months
Title
alertness (ability to stay awake)
Time Frame
12 months
Title
occurrence of metabolic syndrome
Time Frame
12 months
Title
health-related fitness
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katriina T Kukkonen-Harjula, MD, Ph.D.
Organizational Affiliation
UKK Institute for Health Promotion Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Finnish Institute of Occupational Health
City
Helsinki
ZIP/Postal Code
FI-00250
Country
Finland
Facility Name
Vitalmed Research Centre & Sleep Clinic
City
Helsinki
ZIP/Postal Code
FI-00420
Country
Finland
Facility Name
UKK Institute for Health Promotion Research
City
Tampere
ZIP/Postal Code
FI-33500
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
27583202
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.
Results Reference
derived
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Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers
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