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.

BACKGROUND New Zealand urgently requires scalable effective behavior change programs to support healthy lifestyles that are tailored to the needs and lived contexts of M ori 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 M ori 32 Pasifika 32 clusters per arm 20 participants per cluster will be individuals aged 18 years who identify with either M ori 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 M ori 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 M ori 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 TRIAL REGISTRATION Australia New Zealand Clinical Trials Register ACTRN12617001484336 http www ANZCTR org au ACTRN12617001484336 aspx Archived by WebCite at http www webcitation org 71DX9BsJb REGISTERED REPORT IDENTIFIER RR1 10 2196 10789