Clinical trial NCT01625039: Impact of Employee Wellness Programme
Official title: The Impact of an Employee Wellness Programme in Clothing/Textile Manufacturing Companies: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Occupational health
cognitive behavioural therapy
physiotherapy
physical activity
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: EQ-5D
timeFrame: Baseline, change in EQ-5D at 6 weeks
Secondary outcomes:
measure: Stanford Exercise Behaviour Scale
timeFrame: Baseline, change in stanford exercise behaviour at 6 weeks
measure: Body Mass Index
timeFrame: Baseline, Change in BMI at 6 weeks
measure: Absenteeism from work
timeFrame: All absenteeism during the six weeks prior, during the six weeks of intervention and six weeks post intervention
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Clothing Factories
state: Observatory
Study officials:
affiliation: University of Cape Town
name: Naila Edries, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edries N, Jelsma J, Maart S. The impact of an employee wellness programme in clothing/textile manufacturing companies: a randomised controlled trial. BMC Public Health. 2013 Jan 11;13:25. doi: 10.1186/1471-2458-13-25.