Protocol for a pilot study of an online (eHealth) intervention to reduce heart disease risk in male taxi drivers
| ISRCTN | ISRCTN29693943 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29693943 |
| EudraCT/CTIS number | Nil Known |
| Secondary identifying numbers | JMcMahon.SREC_June19_V2 |
- Submission date
- 16/12/2021
- Registration date
- 05/01/2022
- Last edited
- 07/09/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims?
Cardiovascular disease (CVD) remains the leading cause of death worldwide, with men at a higher risk of developing the disease compared to their female counterparts. Taxi drivers are at high risk of cardiovascular disease. This increased risk is due to a range of factors, such as their engagement in CVD related risk behaviours including poor nutritional habits, smoking, the overconsumption of alcohol and long periods of sedentary behaviour. However, little has been done to reduce the risk in this population.
To improve engagement and reduce attrition of men in health behaviour change interventions, a gender-specific approach to development is recommended. One such way to tailor an intervention to meet the needs of end-users is through an online platform (eHealth). eHealth interventions targeted at male only participants have proved beneficial in engendering behaviour change and reducing the risk of CVD. However, no eHealth intervention has been developed and tested for this target population. The aim of this study is to pilot test ManGuard, an eHealth intervention for increasing physical activity and reducing CVD risk in male taxi drivers.
Who can participate?
Men aged 18 years or above, working either full-time or part-time as a taxi driver in Northern Ireland.
What does the study involve?
Participants will be randomly allocated into two groups, one that will receive the ManGuard intervention and the other who will no resources relating to the intervention. This will help us to identify whether ManGuard has the potential to improve physical activity and reduce CVD risk in taxi drivers.
ManGuard is an interactive and motivational program will be made up of seven modules, all of which provide information, tips and guidance on the different factors that are increasing the risk of CVD in taxi drivers and how they can make positive changes to reduce their risk. There will be two modules classified as core modules that the participant must complete, with the remaining classified as voluntary.
Over the 7-week trial period, the participants will have the choice of how many modules they wish to complete, advised to complete those that are going to be of the most benefit to them. Participants will be advised to set goals and monitor their progress, with the program also providing automated feedback.
What are the possible benefits and risks of participating?
We do not anticipate any risks associated with ManGuard. The only possible "risk" is slight bruising on the site where the finger is pricked to take blood for the cholesterol and glucose testing.
Where is the study run from?
Queens University Belfast (UK)
When is the study starting and how long is it expected to run for?
January 2019 to December 2025
Who is funding the study?
Department for the Economy (DfE) (UK)
Who is the main contact?
Mr James McMahon, j.mcmahon@qub.ac.uk
Contact information
Scientific
Medical Biology Centre
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom
| Phone | +44 (0)28 9097 2233 |
|---|---|
| j.mcmahon@qub.ac.uk |
Principal Investigator
Medical Biology Centre
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom
| Phone | +44 (0)2890972233 |
|---|---|
| David.Thompson@qub.ac.uk |
Scientific
University of Suffolk
Integrated Care Academy
Waterfront Building
19 Neptune Quay
Ipswich
IP4 1QJ
United Kingdom
| c.ski@uos.ac.uk |
Study information
| Study design | Pilot unblinded randomized wait-list controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | An eHealth intervention (ManGuard) to reduce cardiovascular risk in male taxi drivers: study protocol for a pilot randomised controlled trial |
| Study acronym | ManGuard |
| Study hypothesis | The ManGuard program will help to reduce cardiovascular disease (CVD) risk in male taxi drivers |
| Ethics approval(s) | Approved 20/07/2019, School of Nursing and Midwifery's Ethics Committee, Queens University Belfast (Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL; +44 (0)2890972233; o.perra@qub.ac.uk), ref: JMcMahon.SREC_June19_V2 |
| Condition | Prevention of cardiovascular disease in male taxi drivers |
| Intervention | Randomisation: Randomisation will occur following the collection of baseline data using blocked randomisation, using the Statistical Package for the Social Sciences (SPSS V.24) software. Participants will be randomised evenly between the intervention group and the wait-list control group. Due to the nature of the study, it is not possible to blind either the researcher or participant to the treatment allocation Waitlist-control group: The wait-list control group will not be provided with any materials relating to the intervention or recommendations on how they can improve on their current lifestyle habits to maintain a ‘true control’. Following the completion of data collection at 3 months, the wait-list control group will be offered access to the intervention Intervention group: ManGuard ManGuard will be provided to participants allocated to the intervention group upon the collection of baseline data. ManGuard is a theory driven eHealth intervention, co-designed with end-users, with the aim to reduce CVD risk in male taxi drivers. Following the co-design process, it was identified that the program would need to address a range of lifestyle factors impacting the risk of CVD in male taxi drivers as well as psychological issues. These include physical activity, nutritional habits, smoking, alcohol and stress. The program will be delivered as an application, downloaded to the participants smartphone or tablet, accessible to the user at any time. The program is comprised of seven modules, two classified as essential to complete (core modules) and the remaining five being voluntary, providing the user with the opportunity to access the modules most appropriate for their personal circumstances. Delivery of these modules will be dependent on the order and time in which the user wishes to access them across the 7-week trial period. Each module will take no longer than 10 minutes to complete, with the content focused on providing participants with brief, but motivational, information on CVD-related behaviour or risk factor of interest in the module, and tips on how they can successfully make changes to these as a taxi driver. Each module uses positive and motivational language as a means of improving the likelihood of promoting behaviour change. Alongside the modules, the program will provide participants with the opportunity to set goals and self-monitor their progress. ManGuard will be interactive, with in-app motivational messages being displayed as a form of automated feedback to provide positive reinforcement when they are progressing well towards their goals, or as messages of encouragement if progress is not occurring as they had anticipated. Participants will also be provided with in-app ‘awards’, badges that they can collect for completing milestones such as completing a module or making progress towards a goal. |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility related outcomes: 1. Recruitment and retention rates Measured by identifying the number of participants taking part in the study (from start to end) and number of participants who withdraw from the study at any point. 2. Engagement with the intervention Engagement rates will be assessed by program usage. Analytics will be retrieved weekly, including the amount of times a participant logs into the program, how many modules they access, how long they spend on each module and how frequently they access the progress tracking page 3. Usability and participant satisfaction Obtained as part of a process evaluation through telephone interviews with a subset of participants following the 7-week assessment time point, as well as a satisfaction survey completed by all participants during the 3-month assessment time point. |
| Secondary outcome measures | Assessed at baseline, 7 weeks, and 3 months 1. Clinical indices 1.1 CVD biomarkers (cholesterol and glucose) measured using the Alere Cholestech LDX Analyzer 1.2 Blood pressure (sphygmomanometer) 1.3 BMI (kg/m²) 1.4 Body fat percentage (bioelectrical impedance analysis) 1.5 Waist circumference (cm) (measuring tape) 2. Physical activity (Actigraph GT3X+ accelerometer and the International Physical Activity Questionnaire (IPAQ-SF)) 3. Psychosocial measures 3.1 Health related quality of life (12-item Short Form Health Survey (SF-12)) 3.2 Self-efficacy (General Self-Efficacy Scale (GSE)) 3.3 Social support Multidimensional Scale of Perceived Social Support (MSPSS)) |
| Overall study start date | 01/01/2019 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 30 |
| Participant inclusion criteria | 1. Adult males (18 years or older) 2. Working either part-time or full-time as a taxi driver in Northern Ireland 3. Must have access to the internet and have a smartphone that allows for the downloading of mobile applications 4. Able to consent to participate 5. Able to understand and comprehend English |
| Participant exclusion criteria | 1. Children and young adults (younger than 18 years old) 2. Female gender 3. No access to the internet or a smartphone that would allow for the downloading of a mobile applications 4. Unable to consent to participate 5. Unable to understand and comprehend English |
| Recruitment start date | 01/09/2024 |
| Recruitment end date | 01/06/2025 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
97 Lisburn Rd
Belfast
BT9 7BL
United Kingdom
Sponsor information
University/education
Medical Biology Centre
97 Lisburn Rd
Belfast
BT9 7BL
Northern Ireland
United Kingdom
| Phone | +44 2890972233 |
|---|---|
| nursing@qub.ac.uk | |
| Website | http://www.qub.ac.uk/ |
"ROR" |
https://ror.org/00hswnk62 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- An Roinn Geilleagair, Department for the Economy NI, Department for the Economy (Northern Ireland), Department for the Economy, Northern Ireland, Northern Ireland, Department for the Economy, DfE
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in: - High-impact peer-reviewed journals - Abstracts submission to national and international conferences - Social media including Twitter and Linkedin |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 14/09/2022 | 15/09/2022 | Yes | No |
Editorial Notes
07/09/2023: The following changes were made to the study record:
1. The recruitment start date was changed from 01/09/2023 to 01/09/2024.
2. The recruitment end date was changed from 01/06/2024 to 01/06/2025.
3. Contact details updated.
04/01/2023: The recruitment start date was changed from 01/01/2023 to 01/09/2023.
15/09/2022: Publication reference added.
01/03/2022: The study contact has been updated.
17/01/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/10/2022 to 01/01/2023.
2. The recruitment end date was changed from 01/02/2023 to 01/06/2024.
3. The overall trial end date was changed from 30/05/2023 to 31/12/2025.
4. Contact details updated.
17/12/2021: Trial's existence confirmed by Queen's University Belfast.
