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

Last updated: March 15, 2024
Sponsor: IRCCS Burlo Garofolo
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Standard care

M-health App

Clinical Study ID

NCT05500339
RC 04\2022
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Inability to give informed consent

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Standard care
Phase:
Study Start date:
November 22, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

    Trieste, 34137
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.