Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201806003394129 Date of Registration: 19/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Programme for employee health in South Africa
Official scientific title Uhlelo lokuthuthukisa impilo: A study protocol of the development of a programme for health promotion in a South African pharmaceutical manufacturing company
Brief summary describing the background and objectives of the trial Background: The high prevalence of obesity and related non-communicable diseases (NCD) in South Africa and other developing economies demonstrates that obesity is a global phenomenon and requires immediate intervention at a population-wide level. Aims: Our study will investigate the health-related absenteeism of workers in relationship to specific NCDs, including hypertension, diabetes, and obesity, as well as mental health in the workplace. Using Intervention Mapping, a further aim of this formative study is to conduct a needs analysis and to engage with key stakeholders to develop performance objectives for an obesity intervention programme. Methods: The study will collect data on correlates of obesity and associated diseases to understand determinants thereof in a sample of workers in a pharmaceutical manufacturing company, situated in Johannesburg, South Africa. The data include sociodemographic characteristics, body composition, blood pressure, random glucose, total cholesterol, self-report and objective physical activity measures, sleep pattern, diet, and workplace stress, productivity, and absenteeism. The second phase of the study will include a qualitative study design which includes focus groups with key stakeholders to determine the main objectives for interventions in the workplace. Expected outcomes: Based on current national data, obesity and related metabolic diseases are expected to be high in the sample. Consequently, the prevalence of obesity-related absenteeism is also likely to be high, indicating urgent need for intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PHP
Disease(s) or condition(s) being studied Circulatory System,Mental and Behavioural Disorders,Nutritional, Metabolic, Endocrine,obesity, diabetes, hypertension, dyslipidaemia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/07/2018
Actual trial start date 02/07/2018
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 250
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Uhlelo lokuthuthukisa impilo 6 months 6 months Objectives for intervention will be developed during focus group discussions following a needs analysis formative phase of employee health. 125
Control Group Uhlelo lokuthuthukisa impilo 6 months The control will continue with usual work duties during the trial. 125 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged 18 years and older Employed by Ascendis Pharma, Ascendis Health Ability to participate in an behavioural modification intervention Male or Female Employed outside of Ascendis Health Pregnant Terminally ill Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/06/2018 Human Research Ethics Committee (Medical), University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Phillip Tobias Building, Office 304, 3rd Floor Cnr York Road & 29 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome obesity and associated cardiometabolic diseases The outcomes will be measured from July 2018 to July 2019
Secondary Outcome Absenteeism The outcome will be measured from July 2018 to July 2019.
Secondary Outcome Objective measurement of activity The outcome will be measured from July 2018 to July 2019
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ascendis Pharma 4 Brewery St, Isando, Kempton Park Johannesburg 1600 South Africa
Ascendis Health 31 Georgian Crescent East, Bryanston Johannesburg 2191 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation of South Africa NRF Building, South Gate, CSIR Complex, Meiring Naudé Road, Brummeria Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Research Foundation of South Africa NRF Building, South Gate, CSIR Complex, Meiring Naudé Road, Brummeria Pretoria 0001 South Africa Funding Agency
Secondary Sponsor University of the Witwatersrand 1 Jan Smuts Avenue, Braamfontein Johannesburg 2000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Joni Zhang Kwok Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T. Hong Kong Hong Kong Hong Kong
Nigel Crowther Chemical Pathology, University of the Witwatersrand Johannesburg 2050 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Philippe Gradidge philippe.gradidge@wits.ac.za 0117173372 Centre for Exercise and Sports Medicine, Impilo Building, Wits Education Campus
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior lecturer
Role Name Email Phone Street address
Public Enquiries Philippe Gradidge philippe.gradidge@wits.ac.za 0117173372 Centre for Exercise and Sports Medicine, Impilo Building, Wits Education Campus
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior lecturer
Role Name Email Phone Street address
Scientific Enquiries Philippe Gradidge philippe.gradidge@wits.ac.za 0117173372 Centre for Exercise and Sports Medicine, Impilo Building, Wits Education Campus
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior lecturer
REPORTING
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