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

Abdominal Obesity Clinical Trial

— SF-Truck  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893646
• Other study ID #: R09025
• Secondary ID: SA124344
• Status: Completed
• Phase: N/A
• First received: May 4, 2009
• Last updated: May 29, 2015
• Start date: May 2009
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: UKK Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: January 2015
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 62 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity, Abdominal
• Weight Loss

Intervention

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)

Locations

Country	Name	City	State
Finland	Finnish Institute of Occupational Health	Helsinki
Finland	Vitalmed Research Centre & Sleep Clinic	Helsinki
Finland	UKK Institute for Health Promotion Research	Tampere

Sponsors (4)

Lead Sponsor	Collaborator
UKK Institute	Academy of Finland, Finnish Institute of Occupational Health, Vitalmed Research Centre & Sleep Clinic

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight		12 months	No
Secondary	sleep duration		12 months	No
Secondary	alertness (ability to stay awake)		12 months	No
Secondary	occurrence of metabolic syndrome		12 months	No
Secondary	health-related fitness		12 months	No