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.: PACTR202203694313219 Date of Approval: 25/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A pilot study on the effect of point-of-choice prompts on sedentary behaviour and physical activity amongst office-based workers in University of Benin.
Official scientific title A pilot study on the effect of point-of-choice prompts on sedentary behaviour and physical activity amongst office-based workers in Nigeria.
Brief summary describing the background and objectives of the trial Decreased physical activity and prolonged sedentary behaviour are among the major risk factors for developing non-communicable diseases. There is overarching evidence to suggest that desk-based office workers have low levels of physical activity and and high sedentary levels due to the nature of their work which requires prolonged sitting. Furthermore, the prevalence of sedentary behaviour is increasing swiftly in certain occupations such as that of university workers in low-income countries, and this may accordingly lead to worsened health outcomes across this population. Several interventions have been made to increase physical activity and decrease sedentary at work in this population. One of such intervention is the use of computer-based prompting software. Studies in developed countries have shown promising results. Whilst computer-based point-of-choice (PoC) prompt have shown promising result in reducing sedentary behaviour and increasing physical activity in developed countries, such studies may be impracticable in developing countries as there are limited availability of computers amongst office workers. The use of a smartwatch based PoC prompt amongst office-based workers may be more pragmatic in the designated locality of this proposed study given the affordability of smartwatches and the popularity of their use in the locality of study. It is therefore imperative that the effectiveness of using a prompt in an African population (e.g. Nigeria) should also be ascertained, because results of studies from the western world may hypothetically differ from that of African settings, due to differences in working conditions across these climes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Sedentary Behaviour and Physical Inactivity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 25/04/2022
Actual trial start date
Anticipated date of last follow up 08/08/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Education Only A one time education session for 5-10 minutes A brief education session of 5-10 minutes Participants in this category will be given a thigh worn activpal (model, activPALTM3c PAL Technologies Ltd, Glasgow, Scotland, UK) for a period of one week prior to this intervention to get their baseline data. Thereafter the participants will receive a brief education intervention on the advantages of being more physically active and being less sedentary at work. Thereafter a leaflet will be given to them containing the positive effects of physical activity and the detriments of sedentary behavior to their health. The participants will now be required to put on the thigh worn activpal again to pilot test the efficacy of the intervention (Education only) on the outcomes. 15 Active-Treatment of Control Group
Experimental Group Education and Point of Choice Prompt Smartwatch prompt for 5 seconds after 30 minutes of being sedentary during working hours. A brief education session of 5-10 minutes Smart watch prompt for 5 seconds after 30 minutes of being sedentary during working hours. Participants in this category will be given a thigh worn activpal (model, activPALTM3c PAL Technologies Ltd, Glasgow, Scotland, UK) for a period of one week prior to this intervention to get their baseline data. Thereafter the participant will receive a brief education intervention on the advantages of being more physically active and being less sedentary at work. Thereafter a leaflet containing the benefits of physically activity and detriments of sedentary behavior will be given to the participants. After the education intervention they will be required to put on an Oriamo OSW-16 smart watch which will used to prompt participants for 5 seconds every 30 minutes during working hours to take a break and to engage in some forms of physical activity. The participants will now be required to put on the thigh worn activpal again to pilot test the efficacy of the intervention (Education and Smart-Watch prompt) on the outcomes. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants age would be between 18 and 65 years. Participants will be administrative member staff of the University of Benin. Participants nature of work would require desk-based sitting bout of more than 30 minutes. Participants will be able to provide an informed consent. Participants will be required to be present at work for the allocated time of the study. Any musculoskeletal problems that may prevent sitting for long periods or standing regularly. Individuals who are designated as clerical staff. Adult: 19 Year-44 Year,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
No 12/12/2022 Research Ethics Committee College of Medical Sciences University of Benin
Ethics Committee Address
Street address City Postal code Country
PMB 1154, Ugbowo Benin City 300213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of sitting events greater than 30 minutes At baseline and post intervention
Primary Outcome Number of light intensity physical activity At baseline and post intervention
Secondary Outcome Number of sit to stand transitions At baseline and post intervention
Secondary Outcome Total time spent sitting per week At baseline and post intervention
Secondary Outcome Total step count per week At baseline and post intervention
Secondary Outcome Total sitting time per week At baseline and post intervention
Secondary Outcome Participants satisfaction with intervention design Post Intervention
Secondary Outcome Recruitment, retention and attrition rates Post intervention
Secondary Outcome Total standing time per week At baseline and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin PMB 1154, Ugbowo, Benin City, Nigeria. Benin 300213 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ogedegbe Efosa Peace Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Uwabor Abraham Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ogedegbe Efosa Peace Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria Individual
Primary Sponsor Uwabor Abraham Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Ogbu Vivian Ogechukwu Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Osadiaye Aisosa Osaretin Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Ehiabhi Churchill Ehinomen Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Nwabudike Charles Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Obiakalusi Chidimma Adaeze Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Mr Yinka Akinrolie University of Manitoba, 66 Chancellors Cir, Winnipeg Manitoba R3T 2N2 Canada
Ogedegbe Efosa Peace Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Uwabor Abraham Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Dr Opeyemi Idowu Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Rev Sister Henrietta Fawole Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Opeyemi Idowu opeyemi.idowu@uniben.edu +2347036872825 Department of Physiotherapy, School of Basic Medical Sciences, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Henrietta Fawole henrietta.fawole@uniben.edu +2348160580905 Department of Physiotherapy, School of Basic Medical Sciences, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Physiotherapist
Role Name Email Phone Street address
Principal Investigator Efosa Ogedegbe sunnyefe05@gmail.com +2348142363302 Department of Physiotherapy, School of Basic Medical Sciences, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Researcher
Role Name Email Phone Street address
Principal Investigator Abraham Uwabor abrahamuwabor@gmail.com +2347013561772 Department of Physiotherapy, School of Basic Medical Sciences, University of Benin
City Postal code Country Position/Affiliation
Benin city 300213 Nigeria Researcher
Role Name Email Phone Street address
Public Enquiries Chidimma Obiakalusi obiakalusichidimma@gmail.com +2348107114836 Department of Physiotherapy, School of Basic Medical Sciences, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification will be available. Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researchers who provide a methodologically sound proposal will be given access to the data for individual participant meta-analysis. Proposal should be directed to opeyemi.idowu@uniben.edu or henrietta.fawole@uniben.edu. To gain access, data requestors will need to sign a data access agreement which will be provided through the email given above. Data are available for 5 years and will be sent on request.
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