Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Intervention to Reduce Weight and Increase Workability in Health Care Workers (FINALE-Health)
Primary Purpose
Overweight, Physical Capacity, Musculoskeletal Diseases
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Intervention-group
Control-group
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Weight loss, Physical activity, Cognitive Behavioral Training
Eligibility 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
Sites / Locations
- Department of Sport Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control-group
Intervention-group
Arm Description
Invitation to attend a monthly seminar of 2 hour duration on a wide range of health related topics
Physical exercise, dietary counseling and cognitive behavioral training as a combined intervention
Outcomes
Primary Outcome Measures
weight loss
Weight loss
Secondary Outcome Measures
Muscle strength
Aerobic capacity
Health Check
Questionnaire
Full Information
NCT ID
NCT01015716
First Posted
November 17, 2009
Last Updated
October 16, 2012
Sponsor
University of Aarhus
Collaborators
The Danish Working Environment Research Foundation, The Ministry of Culture Committee on Sports Research, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01015716
Brief Title
Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Intervention to Reduce Weight and Increase Workability in Health Care Workers
Acronym
FINALE-Health
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Danish Working Environment Research Foundation, The Ministry of Culture Committee on Sports Research, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Physical Capacity, Musculoskeletal Diseases, Work Ability, Sick-leave
Keywords
Weight loss, Physical activity, Cognitive Behavioral Training
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control-group
Arm Type
Active Comparator
Arm Description
Invitation to attend a monthly seminar of 2 hour duration on a wide range of health related topics
Arm Title
Intervention-group
Arm Type
Experimental
Arm Description
Physical exercise, dietary counseling and cognitive behavioral training as a combined intervention
Intervention Type
Behavioral
Intervention Name(s)
Intervention-group
Intervention Description
Physical exercise, dietary counseling and cognitive behavioral training as a combined intervention
Intervention Type
Behavioral
Intervention Name(s)
Control-group
Intervention Description
Invitation to attend a monthly seminar of 2 hour duration on a wide range of health related topics
Primary Outcome Measure Information:
Title
weight loss
Time Frame
3 months
Title
Weight loss
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Muscle strength
Time Frame
3 months
Title
Aerobic capacity
Time Frame
3 months
Title
Health Check
Time Frame
1 year
Title
Questionnaire
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanette R. Christensen, M.Sc. PT
Organizational Affiliation
Department of Sport Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Sport Science
City
Aarhus
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
30612549
Citation
Christensen JR, Pajevic M, Ilvig PM, Sogaard K, Jessen-Winge C. Why people engage in a weight loss intervention at their workplace - a stratified case study. BMC Public Health. 2019 Jan 7;19(1):20. doi: 10.1186/s12889-018-6346-0.
Results Reference
derived
PubMed Identifier
26641838
Citation
Christensen JR, Kongstad MB, Sjogaard G, Sogaard K. Sickness Presenteeism Among Health Care Workers and the Effect of BMI, Cardiorespiratory Fitness, and Muscle Strength. J Occup Environ Med. 2015 Dec;57(12):e146-52. doi: 10.1097/JOM.0000000000000576.
Results Reference
derived
PubMed Identifier
22871173
Citation
Christensen JR, Overgaard K, Carneiro IG, Holtermann A, Sogaard K. Weight loss among female health care workers--a 1-year workplace based randomized controlled trial in the FINALE-health study. BMC Public Health. 2012 Aug 8;12:625. doi: 10.1186/1471-2458-12-625.
Results Reference
derived
PubMed Identifier
21871113
Citation
Christensen JR, Faber A, Ekner D, Overgaard K, Holtermann A, Sogaard K. Diet, physical exercise and cognitive behavioral training as a combined workplace based intervention to reduce body weight and increase physical capacity in health care workers - a randomized controlled trial. BMC Public Health. 2011 Aug 27;11:671. doi: 10.1186/1471-2458-11-671.
Results Reference
derived
PubMed Identifier
20214807
Citation
Holtermann A, Jorgensen MB, Gram B, Christensen JR, Faber A, Overgaard K, Ektor-Andersen J, Mortensen OS, Sjogaard G, Sogaard K. Worksite interventions for preventing physical deterioration among employees in job-groups with high physical work demands: background, design and conceptual model of FINALE. BMC Public Health. 2010 Mar 9;10:120. doi: 10.1186/1471-2458-10-120.
Results Reference
derived
Learn more about this trial
Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Intervention to Reduce Weight and Increase Workability in Health Care Workers
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