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
  Purpose

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.


Condition Intervention Phase
Overweight
Physical Capacity
Musculoskeletal Diseases
Work Ability
Sick-leave
Behavioral: Intervention-group
Behavioral: Control-group
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Life-style Intervention to Reduce Weight and Increase Workability in Health Care Workers

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 146
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015716

Locations
Denmark
Department of Sport Science
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
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
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01015716     History of Changes
Other Study ID Numbers: FINALE-Health
Study First Received: November 17, 2009
Last Updated: October 16, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Weight loss
Physical activity
Cognitive Behavioral Training

Additional relevant MeSH terms:
Musculoskeletal Diseases
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 09, 2014