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

Madeleine France-Ratcliffe; Hannah E Christie; Sarah Blunden; Rachelle S Opie; Elysha Chua; Nazgol Karimi; Brittany Markides; Alison C Uldrich; Ellinor K Olander; Rhiannon L White; Paige van der Pligt; Jane Willcox; Gavin Abbott; Jane Denton; Miriam Lewis; Maria Apostolopoulos; Penelope Love; Anita Lal; Mats Hallgren; Sarah Costigan; Mitch J Duncan; Megan Teychenne

doi:10.1016/j.cct.2023.107383

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

Contemp Clin Trials. 2024 Jan:136:107383. doi: 10.1016/j.cct.2023.107383. Epub 2023 Nov 5.

Authors

Madeleine France-Ratcliffe¹, Hannah E Christie², Sarah Blunden³, Rachelle S Opie⁴, Elysha Chua⁴, Nazgol Karimi⁴, Brittany Markides⁴, Alison C Uldrich⁴, Ellinor K Olander⁵, Rhiannon L White⁶, Paige van der Pligt⁷, Jane Willcox⁸, Gavin Abbott⁴, Jane Denton⁹, Miriam Lewis⁹, Maria Apostolopoulos⁴, Penelope Love⁴, Anita Lal¹⁰, Mats Hallgren¹¹, Sarah Costigan⁴, Mitch J Duncan¹², Megan Teychenne⁴

Affiliations

¹ Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia. Electronic address: madeleinefrance@live.com.
² School of Medical, Indigenous, and Health Sciences, University of Wollongong, Wollongong, Australia.
³ Appleton Institute of Behavioural Science, Central Queensland University, Adelaide, Australia.
⁴ Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.
⁵ Centre for Maternal and Child Health Research, School of Health and Psychological Sciences, City, University of London, London, UK.
⁶ School of Health Sciences, Western Sydney University, Penrith, NSW, Australia.
⁷ Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia; Department of Nutrition, Western Health, Footscray, Victoria, Australia.
⁸ Impact Obesity, South Melbourne, Australia.
⁹ FOMOS Consumer and Stakeholder Advisory Committee, Melbourne, Australia.
¹⁰ Deakin Health Economics, Institute for Health Transformation, Deakin University, Geelong, Australia.
¹¹ Department of Public Health Sciences, Karolinska Institute, Sweden.
¹² School of Medicine & Public Health, College of Health, Medicine, and Wellbeing, The University of Newcastle, Australia; Active Living Research Program, Hunter Medical Research Institute, New Lambton Heights, Australia.

PMID: 37935305
DOI: 10.1016/j.cct.2023.107383

Abstract

Background: Postnatal depression (PND) is a leading cause of illness and death among women following childbirth. 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 equipment, 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.

Keywords: Behaviour change; Postpartum depression; lifestyle intervention; mental health.

Publication types

Clinical Trial Protocol

MeSH terms

Australia
Behavior Therapy
Depression / therapy
Depression, Postpartum* / diagnosis
Depression, Postpartum* / prevention & control
Female
Humans
Mental Health
Randomized Controlled Trials as Topic
Sleep
Sleep Initiation and Maintenance Disorders*