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

October 16, 2012 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

146

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Department of Sport Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: 1 year
1 year
weight loss
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Aerobic capacity
Time Frame: 3 months
3 months
Questionnaire
Time Frame: 1 year
1 year
Muscle strength
Time Frame: 3 months
3 months
Health Check
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

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

Investigators

  • Principal Investigator: Jeanette R. Christensen, M.Sc. PT, Department of Sport Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

October 17, 2012

Last Update Submitted That Met QC Criteria

October 16, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FINALE-Health

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight

Clinical Trials on Control-group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe