Impact of Employee Wellness Programme

NCT ID: NCT01625039

Last Updated: 2012-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Participated in weekly educational workshops

Group Type EXPERIMENTAL

Employee wellness programme

Intervention Type 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.

Control group

Received once off educational session and materials

Group Type ACTIVE_COMPARATOR

Comparator (Once off educational session and educational materials)

Intervention Type BEHAVIORAL

Once off educational session and educational materials

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Comparator (Once off educational session and educational materials)

Once off educational session and educational materials

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Exercise classes Health education

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Cape Town

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Naila Edries

Clinical Educator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Naila Edries, BSc

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clothing Factories

Cape Town, Observatory, South Africa

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Africa

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23311458 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.