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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
360
Pregnant women receive the App designed for the support of the first 1000 days of life
Pregnant women receive standard supportive and educational methods.
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, Italy
RECRUITINGBetween groups differences in the adherence of pregnant women to Tetanus, Diphtheria, Pertussis (TDaP) vaccination
Number of vaccination in pregnancy carried out in the two groups
Time frame: Within the second year of child life
Between groups differences in women knowledge
Differences between experimental and control group in health prevention and promotion knowledge evaluated with questionnaire (closed questions with the following possibile answers: true/false/I don't know)
Time frame: Immediately at the end of first trimester of pregnancy
Between groups differences in women behaviors
Differences between experimental and control group in health prevention and promotion behaviors evaluated with questionnaire (questions with five-level Likert scale answers from 1 to 5, when 1=Strongly disagree and 5=Strongly agree)
Time frame: Immediately at the end of first trimester of pregnancy
Between groups differences in women knowledge
Differences between experimental and control group in health prevention and promotion knowledge evaluated with questionnaire (closed questions with the following possibile answers: true/false/I don't know)
Time frame: At the end of second trimester of pregnancy
Between groups differences in women behaviors
Differences between experimental and control group in health prevention and promotion behaviors evaluated with questionnaire (questions with five-level Likert scale answers from 1 to 5, when 1=Strongly disagree and 5=Strongly agree)
Time frame: At the end of second trimester of pregnancy
Between groups differences in women knowledge
Differences between experimental and control group in health prevention and promotion knowledge evaluated with questionnaire (closed questions with the following possibile answers: true/false/I don't know)
Time frame: Within the second year of child life
Between groups differences in women behaviors
Differences between experimental and control group in health prevention and promotion behaviors evaluated with questionnaire (questions with five-level Likert scale answers from 1 to 5, when 1=Strongly disagree and 5=Strongly agree)
Time frame: Within the second year of child life
Between groups differences in Health literacy level
Differences between experimental and control group in Health literacy level measured with the Italian version of the 16-items European Health Literacy Survey Questionnaire (HLS-EU-Q16)
Time frame: Immediately at the end of first trimester of pregnancy
Between groups differences in Health literacy level
Differences between experimental and control group in Health literacy level measured with the Italian version of the 16-items European Health Literacy Survey Questionnaire (HLS-EU-Q16)
Time frame: Immediately at the end of second trimester of pregnancy
Between groups differences in Health literacy level
Differences between experimental and control group in Health literacy level measured with the Italian version of the 16-items European Health Literacy Survey Questionnaire (HLS-EU-Q16)
Time frame: Within the second year of child life
Between groups differences in social and health impact
Differences between experimental and control group in social and health impact evaluated with questionnaire (i.e., number and type of contacts with health services; time spent on internet to collect health information and ease of information retrieval; ease of sharing information on pregnancy and post-partum within the household; ability to manage health during pregnancy and in the post-partum period)
Time frame: Within the second year of child life
Appreciation of the mHealth App
Only for the experimental group, appreciation of the mHealth app to bridge the information gap between citizens and health institutions, evaluated with questionnaire
Time frame: Within the second year of child life
MHealth app usage data
Collection of data about App usage for the experimental group, i.e., App access frequency, content consultation, references consultation, App features use
Time frame: Within the second year of child life
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