A co-designed, culturally-tailored mhealth tool to support healthy lifestyles in māori and pasifika communities in New Zealand: Protocol for a cluster randomized controlled trial

© Marjolein Verbiest, Suaree Borrell, Sally Dalhousie, Ridvan Tupa'i-Firestone, Tevita Funaki, Deborah Goodwin, Jacqueline Grey, Akarere Henry, Emily Hughes, Gayle Humphrey, Yannan Jiang, Andrew Jull, Crystal Pekepo, Jodie Schumacher, Lisa Te Morenga, Megan Tunks, Mereaumate Vano, Robyn Whittaker, Cliona Ni Mhurchu. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.08.2018. This is an open-access article distributed under the terms of the Creative Commons Attribution License. Background: New Zealand urgently requires scalable, effective, behavior change programs to support healthy lifestyles that are tailored to the needs and lived contexts of Māori and Pasifika communities. Objective: The primary objective of this study is to determine the effects of a co-designed, culturally tailored, lifestyle support mHealth tool (the OL@-OR@ mobile phone app and website) on key risk factors and behaviors associated with an increased risk of noncommunicable disease (diet, physical activity, smoking, and alcohol consumption) compared with a control condition. Methods: A 12-week, community-based, two-arm, cluster-randomized controlled trial will be conducted across New Zealand from January to December 2018. Participants (target N=1280; 64 clusters: 32 Māori, 32 Pasifika; 32 clusters per arm; 20 participants per cluster) will be individuals aged ≥18 years who identify with either Māori or Pasifika ethnicity, live in New Zealand, are interested in improving their health and wellbeing or making lifestyle changes, and have regular access to a mobile phone, tablet, laptop, or computer and to the internet. Clusters will be identified by community coordinators and randomly assigned (1:1 ratio) to either the full OL@-OR@ tool or a control version of the app (data collection only plus a weekly notification), stratified by geographic location (Auckland or Waikato) for Pasifika clusters and by region (rural, urban, or provincial) for Māori clusters. All participants will provide self-reported data at baseline and at 4- and 12-weeks postrandomization. The primary outcome is adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score at 12 weeks that assesses smoking behavior, fruit and vegetable intake, alcohol intake, and physical activity. Secondary outcomes include self-reported body weight, holistic health and wellbeing status, medication use, and recorded engagement with the OL@-OR@ tool. Results: Trial recruitment opened in January 2018 and will close in July 2018. Trial findings are expected to be available early in 2019. Conclusions: Currently, there are no scalable, evidence-based tools to support Māori or Pasifika individuals who want to improve their eating habits, lose weight, or be more active. This wait-list controlled, cluster-randomized trial will assess the effectiveness of a co-designed, culturally tailored mHealth tool in supporting healthy lifestyles.