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

CARE 1000. Randomized Control Trial for the Evaluation of the Effectiveness of a mHealth App for Supporting the First 1000 Days of Life

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05500339
Acronym
CARE1000
Enrollment
360
Registered
2022-08-15
Start date
2022-11-22
Completion date
2024-12-31
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health-Related Behavior

Keywords

mHealth application, first 1000 days, health prevention

Brief 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.

Interventions

Pregnant women receive the App designed for the support of the first 1000 days of life

OTHERStandard care

Pregnant women receive standard supportive and educational methods.

Sponsors

IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Between groups differences in the adherence of pregnant women to Tetanus, Diphtheria, Pertussis (TDaP) vaccinationWithin the second year of child lifeNumber of vaccination in pregnancy carried out in the two groups

Secondary

MeasureTime frameDescription
Between groups differences in women behaviorsImmediately at the end of first trimester of pregnancyDifferences 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)
Between groups differences in Health literacy levelImmediately at the end of first trimester of pregnancyDifferences 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)
Between groups differences in women knowledgeImmediately at the end of first trimester of pregnancyDifferences 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)
Appreciation of the mHealth AppWithin the second year of child lifeOnly for the experimental group, appreciation of the mHealth app to bridge the information gap between citizens and health institutions, evaluated with questionnaire
MHealth app usage dataWithin the second year of child lifeCollection of data about App usage for the experimental group, i.e., App access frequency, content consultation, references consultation, App features use
Between groups differences in social and health impactWithin the second year of child lifeDifferences 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)

Countries

Italy

Contacts

Primary ContactTamara Stampalija, MD
tamara.stampalija@burlo.trieste.it040.3785.486

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026