OL@-OR@ trial: a cluster-randomised controlled trial to evaluate a co-designed, culturally-tailored, lifestyle-support mobile health (mHealth) tool, which includes an app and website for Maori and Pasifika in New Zealand

The OL@-OR@ trial is a pragmatic, community-based, two-arm, cluster randomised trial, including 48 clusters with 40 participants per cluster (24 Maori clusters and 24 Pasifika clusters). Clusters will be randomly assigned (1:1 ratio) to one of two groups: 1) the full OL@-OR@ mhealth tool (app/web version; intervention group), or 2) a simplified version of the mhealth tool (app/web version; control group). It will be up to the participants how often they utilise the app within the 12 week period and they are able to use the app from any location with internet access. All participants will be followed for 12 weeks with assessments at baseline, 4 and 12 weeks which includes demographics, lifestyle questions (fruit and vegetable intake, physical activity, smoking and alcohol intake, Maori/ Pasifika wellbeing questions and feedback on the app will also be collected at 12 weeks. The intervention will be delivered through a mobile app or web version, however Community Coordinators will be involved with recruiting participants and supporting them with registering and using the tool. The Community Coordinators are from our Maori and Pasifika communities who have been involved from the start of the project in the co-design phase. The full OL@-OR@ tool (app and web versions) includes; - Support for participants to set goals as an individual or family and invite others to join them in their journey to achieve these goals. - Participants are encouraged to set additional tasks to help them to achieve their goals. - Participants receive reward tokens for achieving their goals. - There are a number of behavioural change culturally tailored resources throughout the app such as lifestyle trackers, recipes, links to helpful websites, nutritional and physical activity information and local activities such as food markets and exercise classes. - The app also sends regular reminders and motivational messages to help participants reach their goals. - Participants interact with the content by setting goals, sharing with friends and inviting others to use the app, uploading recipes and local activities and by utilising the tips around physical activity and nutrition. The simplified version of the tool: - A countdown until when they will receive the full app - One message a week letting them know when they will receive the full app - Reminders to complete the questionnaires at 4 weeks and 12 weeks post registration. - The only interaction required for the control app is leaving the app on their phone and completing the questionnaires at the required time points. Adherence will be assessed by collecting data in the app around how a participant interacts with the app. This includes looking at data around: - The total number of times a participant accesses the app during the study. - The time elapsed between each session the participant accessed the app - Number of goals a user sets This will be monitored by the research team at the National Institute for Health Innovation (NIHI) NIHI will also monitor whether participants have completed their registration, 4 week questionnaire and 12 week questionnaire. Reminders will go out to participants 1 week prior, on the questionnaire due date and 1 week after the questionnaire is due (if not already completed) to remind participants to complete the questionnaire. An email will also be automatically generated and sent to the participants Community Coordinator to chase up any questionnaires not complete.