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.: PACTR202311701599153 Date of Approval: 01/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The IIDEA study -Intervention to Increase Digital Engagement and Application for Physical Activity
Official scientific title Preliminary findings of the Intervention to Increase Digital Engagement and Application for Physical Activity (IIDEA Study)
Brief summary describing the background and objectives of the trial The use of modern technology to advertise and promote physical activity (PA) interactively as well as to record physical parameters that may indicate the level of fitness (e.g., pedometers and other wearable devices) are promising tools to enhance and measure home-based workouts, although specific recommendations on their use and associated goals remain scarce. Some of these applications include behaviour modification strategies delivered through text messaging, prompts and/or connection with a professional personal coach, and can therefore increase PA levels. Physical activity interventions delivered through applications on mobile devices have provided new ways to help individuals increase PA levels. However, poor adherence with these applications limits the ability to understand the effectiveness of these behavior modifying tools. The purpose of this study was to determine the effect of adding a questionnaire intervention to an existing mobile physical activity application member journey, on user engagement and physical activity levels. Using the Technogym MyWellness 6.0 mobile physical activity applications, an 8-week intervention was used to increase engagement with physical activity applications to increase activity engagement of participants. The app’s member journey was used to track details, assessment, and training programmes. Background: The purpose of this study was to determine the effect of adding a questionnaire intervention to an existing mobile physical activity application member journey, on user engagement and physical activity levels. Method: Using the Technogym MyWellness 6.0 mobile physical activity applications, an 8-week intervention was used to increase engagement with physical activity applications to increase activity engagement of participants. The app’s member journey was used to track details, assessment, and training programmes. The ethical clearance was applied for and obtained from the University of the Witwatersrand
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,PAR-Q questionnaire increase the user engagement and physical activity levels
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/11/2021
Actual trial start date 13/12/2021
Anticipated date of last follow up 17/01/2022
Actual Last follow-up date 20/05/2022
Anticipated target sample size (number of participants) 22
Actual target sample size (number of participants) 36
Recruitment status Completed
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Experimental Group Once off informed consent form given to the coach for the members that were filling out the questionnaire at the beginning of the signing up to the gym. 12 Weeks The fitness centres that were involved in the study, used the Technogym (TG) MyWellness 6.0 mobile physical activity application in their member journey. All member, details, assessments, training programs, tracking of activity and connecting with a coach were routinely set-up with the member on the TG MyWellness 6.0 mobile application. Every new member that signed up at the two fitness centres had an induction meeting with a “coach” of the facility. The coach performed the normal, existing procedures with the member. The coach however, presented and administer the questionnaire to only every alternate member (experimental group). Members that were not offered to fill out the questionnaire were part of the control group. 19
Control Group Control Group Regular physical activity without the PARQ at the beginning of the experiment. 12 weeks Every new member that signed up at the fitness centres had an induction meeting with a “coach” of the facility. The coach performed the normal, existing procedures with the member. The coach however, presented and administered the questionnaire to only every alternate member (experimental group). Members that were not offered to fill out the questionnaire were part of the control group. 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals over the age of 18 years. Participants had to comply and attend 70-80% of the physical activity. Individuals who presented with physical disability or had any other co-morbidity that may had affect their physical abilities. Individuals with mental or physical disabilities that would have prevent them from answering the questionnaires effectively and participating in physical to their full potential. Individuals who were already part of the Technogym mywellness taking part in any form of regular physical routine. Individuals who were pregnant. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 70 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 13/10/2021 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
esearch Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown, 2193. Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The first part questionnaire is based on the Transtheoretical model of behaviour change. Baseline and at the end of intervention
Secondary Outcome The second part of questionnaire is based on the Self Determination Theory of behaviour change and the Health Belief model that highlight self-efficacy, individual autonomy, perceived benefits and the affective value of a goal/action as some determinants of physical activity behaviour change. The third part of the questionnaire then highlighted features of the MyWellness 6.0 application i.e. physical activity services that the mobile application offered. Baseline and at the end of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
TechnoGym Mywellness 8 Eastwood Road, Dunkeld West Johannesburg 2196 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded 27 St Andrews Rd Johannesburg 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self Funded 27 St Andrews Rd Johannesburg 2193 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mandisa Simamane Mandisa.Simamane@wits.ac.za +27117173372 27 St Andrews Rd
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Lecturer University of the Witwatersrand
Role Name Email Phone Street address
Principal Investigator Georgia Torres Georgia.Torres@wits.ac.za +277173372 27 St Andrew Rd
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Lecturer University of the Witwatersrand
Role Name Email Phone Street address
Scientific Enquiries Philippe Gradidge Philippe.Gradidge@wits.ac.za 0117173372 27 St Andrews Rd
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Professor University of the Witwatersrand
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets generated and analysed during the current study are not publicly available due Human Research Ethics Committee (Medical), of the University of the Witwatersrand policies but are available from the corresponding author on reasonable request by the journal. Informed Consent Form,Statistical Analysis Plan,Study Protocol 5 years Controlled access, University of the Witwatersrand Human Research Ethics Committee (Medical), will be available to journal manuscripts submitted to
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 24/10/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 24/10/2023 Result - 24/10/2023 Result - 24/10/2023 Result - 24/10/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information