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

Abstract

Background: Physical inactivity, sedentary behaviour, and poor diet and sleep quality are risk factors for postnatal depression (PND), a mental illness experienced by 23-64% of postnatal women globally. Home-based interventions can help overcome unique barriers to behaviour change during the postnatal period (e.g., limited childcare) and may offer practical solutions for supporting change in health behaviours that enhance postnatal mental health. However, high-quality RCTs testing these approaches are limited.   Purpose: Examine the efficacy and acceptability of a multi-behavioural home-based program (FOMOS) designed to improve PND symptoms in postnatal women (2-arm RCT design).   Methods: FOMOS is a 6-month program, targeting improved diet quality, physical activity (PA), sedentary behaviour, sleep and mental health. The program, aligned with social cognitive theory, involves providing exercise equipment, educational/motivational material (e.g., goal setting, self-monitoring) and social support via eHealth (website, SMS/email) and social media (Instagram). 245 eligible postnatal Australian women with heightened PND symptoms (Edinburgh Postnatal Depression Scale (EDPS) score: 10) will be randomised. Data collection at 0, 3, 6 and 12 months will assess the primary outcome of PND symptoms (via EPDS). Secondary outcomes (diet quality, PA, sitting time, sleep quality) are assessed using established self-report and device measures. Process evaluations will explore implementation outcomes and program acceptability (adoption, acceptability, appropriateness, cost-effectiveness, feasibility, penetration, sustainability).   Results and conclusions: If efficacious, FOMOS has potential to become a practical preventative care pathway for women with PND symptoms to improve their health behaviours and mental health during an especially vulnerable period.