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Impact of Employee Wellness Programme

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ClinicalTrials.gov Identifier: NCT01625039
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : June 21, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The introduction of a wellness programme for workers employed in a clothing factory will improve quality of life, pain, attendance at work and levels of physical activity.

Condition or disease Intervention/treatment
Obesity Behavioral: Employee wellness programme Behavioral: Comparator (Once off educational session and educational materials)

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of an Employee Wellness Programme in Clothing/Textile Manufacturing Companies: A Randomised Control Trial
Study Start Date : January 2008
Primary Completion Date : September 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention
Participated in weekly educational workshops
Behavioral: Employee wellness programme
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 Name: Exercise classes
Active Comparator: Control group
Received once off educational session and materials
Behavioral: Comparator (Once off educational session and educational materials)
Once off educational session and educational materials
Other Name: Health education

Outcome Measures

Primary Outcome Measures :
  1. EQ-5D [ Time Frame: Baseline, change in EQ-5D at 6 weeks ]
    Generic Health Related Quality of Life measure

Secondary Outcome Measures :
  1. Stanford Exercise Behaviour Scale [ Time Frame: Baseline, change in stanford exercise behaviour at 6 weeks ]
    Self reported participation in different forms of physical exercise

  2. Body Mass Index [ Time Frame: Baseline, Change in BMI at 6 weeks ]
    Measurement of height and weight using standardized scales.

  3. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625039

South Africa
Clothing Factories
Cape Town, Observatory, South Africa, 7925
Sponsors and Collaborators
University of Cape Town
Principal Investigator: Naila Edries, BSc University of Cape Town
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Naila Edries, Clinical Educator, University of Cape Town
ClinicalTrials.gov Identifier: NCT01625039     History of Changes
Other Study ID Numbers: 1
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Naila Edries, University of Cape Town:
Occupational health
cognitive behavioural therapy
physical activity