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Published in: Trials 1/2022

Open Access 01-12-2022 | Study protocol

CARE 1000: randomized controlled trial for the evaluation of the effectiveness of a mHealth app for supporting the first 1000 days of life

Authors: Laura Brunelli, Sofia Bussolaro, Margherita Dal Cin, Luca Ronfani, Sara Zanchiello, Andrea Cassone, Giuseppa Verardi, Raffaella Dobrina, Michele Bava, Tamara Stampalija

Published in: Trials | Issue 1/2022

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Abstract

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.
Appendix
Available only for authorised users
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Metadata
Title
CARE 1000: randomized controlled trial for the evaluation of the effectiveness of a mHealth app for supporting the first 1000 days of life
Authors
Laura Brunelli
Sofia Bussolaro
Margherita Dal Cin
Luca Ronfani
Sara Zanchiello
Andrea Cassone
Giuseppa Verardi
Raffaella Dobrina
Michele Bava
Tamara Stampalija
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06953-y

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