Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Intervention to Reduce Weight and Increase Workability in Health Care Workers (FINALE-Health)

This study has been completed.

Sponsor:

Collaborators:

The Danish Working Environment Research Foundation

The Ministry of Culture Committee on Sports Research, Denmark

Information provided by (Responsible Party):

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01015716

First received: November 17, 2009

Last updated: October 16, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2009

Last Updated Date

October 16, 2012

Start Date ^ICMJE

November 2009

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01015716 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Muscle strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Aerobic capacity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Health Check [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Intervention to Reduce Weight and Increase Workability in Health Care Workers

Official Title ^ICMJE

Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Life-style Intervention to Reduce Weight and Increase Workability in Health Care Workers

Brief 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.

Detailed 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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Overweight
Physical Capacity
Musculoskeletal Diseases
Work Ability
Sick-leave

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Control-group
Invitation to attend a monthly seminar of 2 hour duration on a wide range of health related topics

Intervention: Behavioral: Control-group
Experimental: Intervention-group
Physical exercise, dietary counseling and cognitive behavioral training as a combined intervention

Intervention: Behavioral: Intervention-group

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

146

Completion Date

May 2012

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01015716

Other Study ID Numbers ^ICMJE

FINALE-Health

Has Data Monitoring Committee

Yes

Responsible Party

University of Aarhus

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

The Danish Working Environment Research Foundation
The Ministry of Culture Committee on Sports Research, Denmark

Investigators ^ICMJE

Principal Investigator:

Jeanette R. Christensen, M.Sc. PT

Department of Sport Science

Information Provided By

University of Aarhus

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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