Abdominal ObesitySF-TruckNCT00893646
Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers
A study testing weight loss counseling in people with Abdominal Obesity, run by UKK Institute at 3 sites in Finland.
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… Read more about this study
- Who is it for?
- Ages 30 to 62 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- weight loss counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 3 sitesFinland
- Study dates
- May 2009to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 62 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Finnish Institute of Occupational Health
Helsinki, FI-00250
Vitalmed Research Centre & Sleep Clinic
Helsinki, FI-00420
UKK Institute for Health Promotion Research
Tampere, FI-33500
About this study
Official title: Effects of Weight Reduction and Lifestyle Changes on Sleep, Alertness and Cardiometabolic Risk Factors in Overweight Professional Long-distance Drivers
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.
Read the 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
- Being tested
- weight loss counseling
- 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
- Medical subject headings
- Obesity, Abdominal, Weight Loss, Sleep Hygiene, Disorders of Excessive Somnolence, Metabolic Syndrome, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight loss counselingBehavioural
Also called lifestyle 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)
| Study group | Role | What they receive |
|---|---|---|
| weight loss counseling | Experimental | individual monthly counseling on diet, physical activity and sleep Receives: Behavioral: weight loss counseling |
| control | No intervention | no lifestyle advice, yearly assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
Measured: 12 months
Secondary outcomes (4)
sleep duration
Measured: 12 months
alertness (ability to stay awake)
Measured: 12 months
occurrence of metabolic syndrome
Measured: 12 months
health-related fitness
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2012
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- UKK Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Finland, Finnish Institute of Occupational Health, Vitalmed Research Centre
- Responsible party
- Principal investigator, Katriina Kukkonen-Harjula, UKK Institute
- Investigators
- Katriina T Kukkonen-Harjula, MD, Ph.D., Principal investigator, UKK Institute for Health Promotion Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893646
- Sponsor's protocol ID
- R09025
- Other IDs
- SA124344
- Acronym
- SF-Truck
- Status last verified
- May 2015
- First submitted
- 4 May 2009
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27583202
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weight Reduction and Lifestyle Changes on Sleep, Alertness and Cardiometabolic Risk Factors in Overweight Professional Long-distance Drivers
- ClinicalTrials.gov ID
- NCT00893646
- Acronym / sponsor ID
- SF-Truck / R09025
- Conditions
- Abdominal Obesity
- Keywords
- abdominal obesity, weight reduction, diet, exercise training, lifestyle activity, health-related fitness, walking, actigraphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- UKK InstituteUniversity, hospital or other
- Collaborators
- Academy of Finland, Finnish Institute of Occupational Health, Vitalmed Research Centre
- Study start
- May 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weight loss counseling | Experimental | Behavioral: weight loss counselingindividual monthly counseling on diet, physical activity and sleep |
| control | No intervention | –no lifestyle advice, yearly assessments |
Who may qualify
- Ages
- 30 to 62 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weight loss counselingAlso: lifestyle counselingindividual 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) | Behavioural | weight loss counseling |
Primary outcome
body weight
Time frame: 12 months
4 secondary outcomes
sleep duration
Time frame: 12 months
alertness (ability to stay awake)
Time frame: 12 months
occurrence of metabolic syndrome
Time frame: 12 months
health-related fitness
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Derived from this study: PubMed 27583202Puhkala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katriina T Kukkonen-Harjula, MD, Ph.D. principal investigator
UKK Institute for Health Promotion Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight loss counseling in people with Abdominal Obesity, run by UKK Institute at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00893646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015.