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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01015716
Other study ID # FINALE-Health
Secondary ID
Status Completed
Phase Phase 1
First received November 17, 2009
Last updated October 16, 2012
Start date November 2009
Est. completion date May 2012

Study information

Verified date October 2012
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether a 1 year worksite based life-style intervention can reduce body weight and increase physical capacity and subsequently reduce musculoskeletal disorders and increase workability in overweight health care workers.


Description:

Health care workers have a high rate of musculoskeletal disorders and sick leave and a poor workability and physical fitness. Most studies have focused on increasing physical fitness in order to increase workability and to reduce musculoskeletal disorders and sick leave. Studies however also show that many health care workers are obese and obesity has been linked to poor workability.

Limited research is available on the effect of reducing body-weight in this group in order to increase workability and to decrease musculoskeletal disorders and sick leave.

This study introduces a combined worksite based lifestyle intervention consisting of physical exercise, dietary counseling and cognitive behavioral training aimed at reducing weight in health care workers.

On specific worksites, health care workers are cluster randomized to either intervention or control group.

Effects on physical capacity, body composition, musculoskeletal disorders, workability and sick leave are evaluated before and after a 1 year intervention period


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date May 2012
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Overweight Health care workers, working more than 15 hours pr week

Exclusion Criteria:

- Pregnancy, angina pectoris and life-threatening diseases according to safty regulations for physical evaluation methods

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Intervention

Behavioral:
Intervention-group
Physical exercise, dietary counseling and cognitive behavioral training as a combined intervention
Control-group
Invitation to attend a monthly seminar of 2 hour duration on a wide range of health related topics

Locations

Country Name City State
Denmark Department of Sport Science Aarhus

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus The Danish Working Environment Research Foundation, The Ministry of Culture Committee on Sports Research, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary weight loss 3 months No
Primary Weight loss 1 year No
Secondary Muscle strength 3 months No
Secondary Aerobic capacity 3 months No
Secondary Health Check 1 year No
Secondary Questionnaire 1 year No
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