Moving from intention to behaviour: a randomised controlled trial protocol for an app-based physical activity intervention (i2be)

INTRODUCTION: Efficacy tests of physical activity interventions indicate that many have limited or short-term efficacy, principally because they do not sufficiently build on theory-based processes that determine behaviour. The current study aims to address this limitation. METHODS AND ANALYSIS: The efficacy of the 8-week intervention will be tested using a three-condition randomised controlled trial delivered through an app, in women with a prior hypertensive pregnancy disorder. The intervention is based on the integrated behaviour change model, which outlines the motivational, volitional and automatic processes that lead to physical activity. The mechanisms by which the behaviour change techniques lead to physical activity will be tested. Following stratification on baseline factors, participants will be randomly allocated in-app to one of three conditions (1:1:1). The information condition will receive information, replicating usual care. Additionally to what the information condition receives, the motivation condition will receive content targeting motivational processes. Additionally to what the motivation condition receives, the action condition will receive content targeting volitional and automatic processes. The primary outcome is weekly minutes of moderate-to-vigorous physical activity, as measured by an activity tracker (Fitbit Inspire 2). Secondary outcomes include weekly average of Fitbit-measured daily resting heart rate, and self-reported body mass index, waist-hip ratio, cardiorespiratory fitness and subjective well-being. Tertiary outcomes include self-reported variables representing motivational, volitional, and automatic processes. Outcome measures will be assessed at baseline, immediately post-intervention, and at 3 and 12 months post-intervention. Physical activity will also be investigated at intervention midpoint. Efficacy will be determined by available case analysis. A process evaluation will be performed based on programme fidelity and acceptability measures. ETHICS AND DISSEMINATION: The Medical Ethics Committee of the Erasmus MC has approved this study (MEC-2020-0981). Results will be published in peer reviewed scientific journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER: Netherlands trial register, NL9329.