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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


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
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