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

NCT ID: NCT00893646

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2015-01-31

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.

Conditions

Abdominal Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

weight loss counseling

individual monthly counseling on diet, physical activity and sleep

Group Type: EXPERIMENTAL

weight loss counseling

Intervention Type: 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)

control

no lifestyle advice, yearly assessments

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: BEHAVIORAL

Other Intervention Names

lifestyle counseling

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

UKK Institute

OTHER

Sponsor Role: lead

Academy of Finland

OTHER

Sponsor Role: collaborator

Finnish Institute of Occupational Health

OTHER

Sponsor Role: collaborator

Vitalmed Research Centre

OTHER

Sponsor Role: collaborator

Responsible Party

Katriina Kukkonen-Harjula

senior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katriina T Kukkonen-Harjula, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UKK Institute for Health Promotion Research

Locations

Finnish Institute of Occupational Health

Helsinki, , Finland

Vitalmed Research Centre & Sleep Clinic

Helsinki, , Finland

UKK Institute for Health Promotion Research

Tampere, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 27583202 (View on PubMed)

Other Identifiers

SA124344

Identifier Type: -

Identifier Source: secondary_id

R09025

Identifier Type: -

Identifier Source: org_study_id