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Completed

NCT Number: NCT01625039

Impact of Employee Wellness Programme

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clothing Factories

Cape Town, Observatory, 7925, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Employee wellness programme

Behavioral

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: Exercise classes

Comparator (Once off educational session and educational materials)

Behavioral

Once off educational session and educational materials

Other names: Health education

Primary outcomes

  1. EQ-5D

    Time frame: Baseline, change in EQ-5D at 6 weeks

    Generic Health Related Quality of Life measure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Registry information

Official study title

The Impact of an Employee Wellness Programme in Clothing/Textile Manufacturing Companies: A Randomised Control Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 21, 2012
Registry last updated
Jun 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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