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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201911656014962 Date of Approval: 12/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Standing Up Against Office Sitting
Official scientific title Sedentary behaviour is high among office workers, resulting in increased risk of cardiovascular disease
Brief summary describing the background and objectives of the trial Sedentary behaviour is high among office workers, resulting in increased risk of cardiovascular disease. This trial will detect and address the high sitting time of office workers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/12/2019
Actual trial start date 02/12/2019
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/03/2021
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sit stand group basline, 3 months, 6 months basline, 3 months, 6 months Sitting time will be interrupted by the introduction of sit-stand desks. 30
Control Group Control group basline, 3 months, 6 months basline, 3 months, 6 months Control group will be asked to continue as usual. Data will be collected at 3 timepoints. 30 Dose Comparison
Experimental Group Healthy messages group basline, 3 months, 6 months basline, 3 months, 6 months Healthy messages (e.g. obtain 10000 steps/day) will be sent electronically to participants. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult office workers, working at least 50% of the workday at their desk, 5 days/week Pregnant, non-ambulatory, diagnosed medical or chronic condition that affects ability to stand for at least 10 minutes at a time, working off-site Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 12/02/2019 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 2050 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Interrupted sitting time, measured with activity monitors baseline, 3 months, 6 months
Secondary Outcome Change in cardiometabolic disease outcomes including BMI, glucose, blood pressure, and lipid profile. baseline, 3 months, 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
TransUnion Africa Wanderers Office Park, Corlett Drive Johannesburg 2195 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Initiated Research Grant South African Medical Research Council, Francie van Zijl Drive, Parow Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council Francie van Zijl Drive, Parow Cape Town 7050 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Merling Phaswana 27 St Andrews, Wits Education Campus, Impilo Building, Parktown Johannesburg 2050 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Philippe Gradidge philippe.gradidge@wits.ac.za +27117173372 Centre for Exercise Science and Sports Medicine, 27 St Andrews, Wits Education Campus
City Postal code Country Position/Affiliation
Johannesburg 2050 South Africa Centre for Exercise Science and Sports Medicine University of the Witwatersrand
Role Name Email Phone Street address
Scientific Enquiries Philippe Gradidge philippe.gradidge@wits.ac.za +27117173372 Centre for Exercise Science and Sports Medicine, 27 St Andrews, Wits Education Campus
City Postal code Country Position/Affiliation
Johannesburg 2050 South Africa Centre for Exercise Science and Sports Medicine University of the Witwatersrand
Role Name Email Phone Street address
Public Enquiries Philippe Gradidge philippe.gradidge@wits.ac.za +27117173372 Centre for Exercise Science and Sports Medicine, 27 St Andrews, Wits Education Campus
City Postal code Country Position/Affiliation
Johannesburg South Africa Centre for Exercise Science and Sports Medicine University of the Witwatersrand
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results will be available in peer-reviewed publications Clinical Study Report 12-months post-intervention For meta-analysis
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information