Evaluating a multi-behavioural home-based intervention for reducing depressive symptoms in postnatal women : The food, move, sleep (FOMOS) for postnatal mental health randomised controlled trial protocol

Background: Postnatal depression (PND) is a leading cause of illness and death among women following child-birth. Physical inactivity, sedentary behaviour, poor sleep, and sub-optimal diet quality are behavioural risk factors for PND. A feasible, sustainable, and scalable intervention to improve healthy behaviours and reduce PND symptoms among women at postpartum is needed. This study aims to examine the effectiveness of a multi-behavioural home-based program Food, Move, Sleep (FOMOS) for Postnatal Mental Health designed to improve PND symptoms in women at postpartum.Methods: This randomised clinical trial will recruit 220 Australian women (2-12 months postpartum) experiencing heightened PND symptoms (Edinburgh Postnatal Depression Scale score >= 10). Participants will be randomised to FOMOS or wait-list control receiving standard clinical care. FOMOS is a 6-month mobile health (mHealth) intervention targeting diet quality, physical activity, sedentary behaviour, sleep, and mental health. The intervention, informed by the Social Cognitive Theory and incorporating behaviour change techniques defined in the CALO-RE taxonomy and Cognitive Behavioural Treatment of Insomnia, provides exercise equip-ment, and educational/motivational material and social support via mHealth and social media. Data collection pre-intervention and at 3, 6 and 12 months will assess the primary outcome of PND symptoms and secondary outcomes (diet quality, physical activity, sitting time, sleep quality) using self-report and device measures. Process evaluation will explore acceptability, appropriateness, cost-effectiveness, feasibility, and sustainability via analytic tools, record keeping, interviews, and surveys.Discussion: If effective, FOMOS could be a feasible and potentially scalable management strategy to support improvement of health behaviours and mental health for women with PND symptoms. Trial registration: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12622001079730p