- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01625039
Impact of Employee Wellness Programme
The Impact of an Employee Wellness Programme in Clothing/Textile Manufacturing Companies: A Randomised Control Trial
Study Overview
Status
Conditions
Detailed Description
Introduction: The prevalence of health risk behaviours is growing amongst South African employees. Health risk behaviours have been identified as a major contributor to reduced health related quality of life (HRQoL) and the increase prevalence of non-communicable diseases. Worksite wellness programmes promise to promote behaviour changes amongst employees and to improve their HRQoL.
Aims: The aim of this study was to evaluate the short-term efficacy of an employee wellness programme on HRQoL, health behaviour change, levels of self efficacy, pain intensity, body mass index (BMI) and absenteeism amongst clothing and textile manufacturing employees.
Methods: The study was a randomised control trial consisting of 80 participants from three clothing manufacturing companies in South Africa. The experimental group was subjected to a wellness programme based on the principles of cognitive behaviour therapy (CBT) as well as weekly supervised exercise classes over six weeks. The control group received a once-off health promotion talk and various educational pamphlets, with no further intervention. Measurements were recorded at baseline and at six weeks post-intervention. Outcome measures used included the EQ-5D, Brief Pain Inventory-SF, Stanford Exercise Behaviours Scale, Stanford Self-Efficacy Scale, Stanford Self-Rated Health Scale, BMI and absenteeism.
Data Analysis: All the data were analysed with the Statistica-8 software program. Although t-tests are the most commonly used statistical method for evaluating the differences in the means between two groups (e.g. control and experimental), it assumes that the variable is normally distributed. Thus, because the ordinal data were not normally distributed, non-parametric tests were used to evaluate the differences in the medians between the two groups and to determine the level of significance. The Sign test was used in place of the paired t-test to determine the within group changes. The Mann-Whitney U test was used in place of the independent t-test to determine the difference between the two groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Observatory
-
Cape Town, Observatory, South Africa, 7925
- Clothing Factories
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All factory workers who volunteered to take part in the study
Exclusion Criteria:
- Subjects were excluded from the study if they reported uncontrolled diabetes and hypertension, coronary heart disease or any other illness that rendered participation in the exercise component unsafe.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Participated in weekly educational workshops
|
The experimental group was subjected to a wellness programme based on the principles of cognitive behaviour therapy (CBT) as well as weekly supervised exercise classes over six weeks.
Other Names:
|
Active Comparator: Control group
Received once off educational session and materials
|
Once off educational session and educational materials
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EQ-5D
Time Frame: Baseline, change in EQ-5D at 6 weeks
|
Generic Health Related Quality of Life measure
|
Baseline, change in EQ-5D at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stanford Exercise Behaviour Scale
Time Frame: Baseline, change in stanford exercise behaviour at 6 weeks
|
Self reported participation in different forms of physical exercise
|
Baseline, change in stanford exercise behaviour at 6 weeks
|
Body Mass Index
Time Frame: Baseline, Change in BMI at 6 weeks
|
Measurement of height and weight using standardized scales.
|
Baseline, Change in BMI at 6 weeks
|
Absenteeism from work
Time Frame: All absenteeism during the six weeks prior, during the six weeks of intervention and six weeks post intervention
|
Scrutiny of attendance records
|
All absenteeism during the six weeks prior, during the six weeks of intervention and six weeks post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Naila Edries, BSc, University of Cape Town
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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