CARE 1000: randomized controlled trial for the evaluation of the effectiveness of a mHealth app for supporting the first 1000 days of life.
Laura Brunelli, Sofia Bussolaro, Margherita Dal Cin, Luca Ronfani, Sara Zanchiello, Andrea Cassone, Giuseppa Verardi, Raffaella Dobrina, Michele Bava, Tamara Stampalija
Author Information
Laura Brunelli: Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy. laura.brunelli@phd.units.it. ORCID
Sofia Bussolaro: Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy.
Margherita Dal Cin: Department of Prevention, Giuliano Isontina Healthcare University Trust, Trieste, Italy.
Luca Ronfani: Clinical Epidemiology and Healthcare Services Research, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
Sara Zanchiello: Area Science Park, Trieste, Italy.
Andrea Cassone: Healthcare Professions Department, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
Giuseppa Verardi: Healthcare Professions Department, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
Raffaella Dobrina: Healthcare Professions Department, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
Michele Bava: Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy.
Tamara Stampalija: Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy.
BACKGROUND: Recent developments in eHealth and mobile health (mHealth), as well as the introduction of information and communication technology innovations in clinical practice, such as telemedicine, telemonitoring, and remote examinations, are already changing the current scenario and will continue to generate innovations in the coming decades. The widespread use of mobile devices, with an estimated nearly 30 billion devices and more than 325,000 apps worldwide, will provide various opportunities for people to take control of their own health. Already in 2017, most of the apps available were focused on pregnancy support, more than any other medical field. There have been some reported experiences with social media and mHealth that could benefit the promotion of maternal physical and mental health during pregnancy. However, many apps targeting the first 1000 days of a child's life do not consider the continuity between the prenatal and postnatal periods and their joint impact on maternal and child health. The aim of this study is to evaluate the effectiveness of this mHealth app to support women during the first 1000 days (from conception to 24 months of age) and to improve health prevention behaviours such as immunizations during pregnancy, weight gain during pregnancy, abstinence from smoking and alcohol consumption, and adherence to the routine childhood immunization schedule. In addition, the study aims to understand the level of appreciation of this mHealth app as a tool to overcome information and communication gaps between patients and institutions. METHODS: Conduction of a randomized controlled trial. DISCUSSION: Our results will be relevant for improving this mHealth app to promote health and prevention and to support the first 1000 days of life for both mother and child. Our results will be relevant to the future expansion of such an mHealth app to promote positive health-related outcomes in patients and co-user satisfaction and to support the organization of health services. TRIAL REGISTRATION: ClinicalTrials.gov NCT05500339.
