Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Terminated NCT03299881 - Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss N/A
Completed NCT02805478 - Fat-Associated Cardiovascular Organ Dysfunction
Active, not recruiting NCT02558920 - Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity
Completed NCT03759743 - Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject N/A
Completed NCT03610958 - Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss. N/A
Completed NCT03678766 - CHARGE: Controlling Hunger and ReGulating Eating N/A
Completed NCT04430465 - Effects of Wholegrains on Children's Health (KORN) N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT05376865 - Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers N/A
Completed NCT03625427 - Effect of Palmitoleic Acid on C-reactive Protein N/A
Active, not recruiting NCT03435445 - Online Platform for Healthy Weight Loss (POEmaS) N/A
Enrolling by invitation NCT05576116 - Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics N/A
Recruiting NCT05249465 - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention N/A
Active, not recruiting NCT06023095 - A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities Phase 1
Completed NCT03648892 - Brain Dopamine Function in Human Obesity Early Phase 1
Not yet recruiting NCT05751993 - Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions N/A
Recruiting NCT02887950 - Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause N/A
Completed NCT02829229 - Community-based Obesity Treatment in African American Women After Childbirth N/A
Completed NCT02899390 - Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes N/A