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| Sponsors and Collaborators: |
UKK Institute Academy of Finland Finnish Institute of Occupational Health Vitalmed Research Centre & Sleep Clinic |
|---|---|
| Information provided by: | UKK Institute |
| ClinicalTrials.gov Identifier: | NCT00893646 |
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: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Effects of Weight Reduction and Lifestyle Changes on Sleep, Alertness and Cardiometabolic Risk Factors in Overweight Professional Long-Distance Drivers |
| Estimated Enrollment: | 140 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| weight loss counseling: Experimental |
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)
|
| control: No Intervention |
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 40—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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Katriina Kukkonen-Harjula, MD | +358 3 2829111 ext 222 | katriina.kukkonen-harjula@uta.fi |
| Contact: Kirsi Mansikkamaki, M. Sc. | +358 3 2829111 ext 214 | kirsi.mansikkamaki@uta.fi |
| Finland | |
| UKK Institute for Health Promotion Research | Recruiting |
| Tampere, Finland, FI-33500 | |
| Contact: Katriina T Kukkonen-Harjula, MD, Ph.D. +358 3 2829111 ext 222 katriina.kukkonen-harjula@uta.fi | |
| Finnish Institute of Occupational Health | Active, not recruiting |
| Helsinki, Finland, FI-00250 | |
| Vitalmed Research Centre & Sleep Clinic | Active, not recruiting |
| Helsinki, Finland, FI-00420 | |
| Principal Investigator: | Katriina T Kukkonen-Harjula, MD, Ph.D. | UKK Institute for Health Promotion Research |
More Information
| Responsible Party: | UKK Institute for Health Promotion Research ( Katriina Kukkonen-Harjula, MD, Ph.D. / senior researcher ) |
| Study ID Numbers: | R09025, SA124344 |
| Study First Received: | May 4, 2009 |
| Last Updated: | May 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00893646 History of Changes |
| Health Authority: | Finland: Ethics Committee |
|
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 |
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Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overnutrition Overweight |
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Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overweight Overnutrition |
