NCT00893646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

3.1 years

First QC Date

May 4, 2009

Last Update Submit

May 29, 2015

Conditions

Abdominal Obesity

Keywords

abdominal obesityweight reductiondietexercise traininglifestyle activityhealth-related fitnesswalkingactigraphylifestyle modificationsleepsleep hygienealertnessdaytime sleepinessmetabolic syndromecounsellinghealth educationtruck driversbus driversrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • body weight

    12 months

Secondary Outcomes (4)

  • sleep duration

    12 months

  • alertness (ability to stay awake)

    12 months

  • occurrence of metabolic syndrome

    12 months

  • health-related fitness

    12 months

Study Arms (2)

weight loss counseling

EXPERIMENTAL

individual monthly counseling on diet, physical activity and sleep

Behavioral: weight loss counseling

control

NO INTERVENTION

no lifestyle advice, yearly assessments

Interventions

weight loss counselingBEHAVIORAL

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)

Also known as: lifestyle counseling
weight loss counseling

Eligibility Criteria

Age30 Years - 62 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Finnish Institute of Occupational Health

Helsinki, FI-00250, Finland

Location

Vitalmed Research Centre & Sleep Clinic

Helsinki, FI-00420, Finland

Location

UKK Institute for Health Promotion Research

Tampere, FI-33500, Finland

Location

Related Publications (1)

  • 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.

    PMID: 27583202DERIVED

MeSH Terms

Conditions

Obesity, AbdominalWeight LossSleep HygieneDisorders of Excessive SomnolenceMetabolic SyndromeHealth Education

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesHealth BehaviorBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Study Officials

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

    UKK Institute for Health Promotion Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior researcher

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 6, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2012

Study Completion

January 1, 2015

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

FI(3)