- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01625039
Impact of Employee Wellness Programme
The Impact of an Employee Wellness Programme in Clothing/Textile Manufacturing Companies: A Randomised Control Trial
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Observatory
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Cape Town, Observatory, Sud Africa, 7925
- Clothing Factories
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
Altri nomi:
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Comparatore attivo: Control group
Received once off educational session and materials
|
Once off educational session and educational materials
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
EQ-5D
Lasso di tempo: Baseline, change in EQ-5D at 6 weeks
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Generic Health Related Quality of Life measure
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Baseline, change in EQ-5D at 6 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Stanford Exercise Behaviour Scale
Lasso di tempo: Baseline, change in stanford exercise behaviour at 6 weeks
|
Self reported participation in different forms of physical exercise
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Baseline, change in stanford exercise behaviour at 6 weeks
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Body Mass Index
Lasso di tempo: Baseline, Change in BMI at 6 weeks
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Measurement of height and weight using standardized scales.
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Baseline, Change in BMI at 6 weeks
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Absenteeism from work
Lasso di tempo: All absenteeism during the six weeks prior, during the six weeks of intervention and six weeks post intervention
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Scrutiny of attendance records
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All absenteeism during the six weeks prior, during the six weeks of intervention and six weeks post intervention
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Naila Edries, BSc, University of Cape Town
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 1
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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