Effectiveness of a mHealth App for Supporting the First 1000 Days of Life (CARE1000)

IRCCS Burlo Garofolo

Status: Enrolling

Conditions: Health-Related Behavior

Treatments: Other: Standard care; Other: M-health App

Study type: Interventional

Funder types: Other

Identifiers

NCT05500339

RC 04\2022

Details and patient eligibility

About

Recent development in information and communication technologies has enabled the disruptive expansion of electronic health (eHealth) and mobile health (mHealth). These developments, along with the introduction in clinical practice of technological innovations, such as telemedicine, telemonitoring, and remote screening, are considered essential elements of "game-changing innovations" in the next 25 years. In fact, the widespread distribution of networked devices, which are estimated to reach 29.3 billion in 2023, offers a promising but challenging opportunity of mHealth use for health information seeking, with an important role in health behavior formation. In 2017, more than 325,000 mobile health applications (apps) were available worldwide, and among them, to the best of our knowledge, there were more apps available to support pregnancy than for any other medical domain. These mobile technologies in support of pregnancy have also increased the possibility for both parents and parents-to-be to self-manage health issues; findings from a recent study conducted in 2019 in Switzerland report that 91% of parents declared using digital media for seeking information about their child's health and development. Moreover, a recent meta-analysis showed that social media and mHealth have the potential to be effective in promoting maternal physical health (e.g., weight management), mental health, and knowledge about pregnancy. However, when considering apps addressing children's first 1000 days of life, from conception through age 24 months, many of them just focus on the prenatal or postnatal stage, failing to consider the continuity between the two phases and their joint impact on maternal and child health.

The purpose of this study is to evaluate the mHealth App effectiveness for the support of women during the first 1000 days (from conception through age 24 months) and for improving health prevention behaviors such as vaccination during pregnancy, weight increment during pregnancy, abstinence from smoke and alcohol consumption habits, adherence to child routine vaccination 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 institution.

Enrollment: 360 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women accessing for the first trimester ultrasound.
• Age >= 18 years
• Good comprehension of Italian language
• Possession of a smartphone for the App download
• Willingness to give birth at Institute for Maternal and Child Health Burlo Garofolo, Trieste

Exclusion criteria

• Inability to give informed consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

mHealth App

Experimental group

Description:

The mHealth App designed for the support of the first 1000 days of life is provided to pregnant women. Specific contents are presented to the user according to the current trimester of pregnancy or the post-partum period following a scheduled routine; all contents are always available for free consultation during the entire period of use. Links to relevant institutional websites are also reported for any further reading. The app has a frequently asked question (FAQ) section, and a calendar function with the possibility to set appointments and reminders. App contents and topics include information about health prevention behaviors such as vaccination during pregnancy, weight increment during pregnancy, abstinence from smoke and alcohol consumption habits, adherence to child routine vaccination schedule.

Treatment:

Other: M-health App

Standard care.

Sham Comparator group

Description:

Pregnant women receive standard supportive and educational methods.

Treatment:

Other: Standard care