Clinical trial NCT05500339: Effectiveness of a mHealth App for Supporting the First 1000 Days of Life
Official title: CARE 1000. Randomized Control Trial for the Evaluation of the Effectiveness of a mHealth App for Supporting the First 1000 Days of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health-Related Behavior
Keywords: mHealth application
first 1000 days
health prevention
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Between groups differences in the adherence of pregnant women to Tetanus, Diphtheria, Pertussis (TDaP) vaccination
timeFrame: Within the second year of child life
Secondary outcomes:
measure: Between groups differences in women knowledge
timeFrame: Immediately at the end of first trimester of pregnancy
measure: Between groups differences in women behaviors
timeFrame: Immediately at the end of first trimester of pregnancy
measure: Between groups differences in women knowledge
timeFrame: At the end of second trimester of pregnancy
measure: Between groups differences in women behaviors
timeFrame: At the end of second trimester of pregnancy
measure: Between groups differences in women knowledge
timeFrame: Within the second year of child life
measure: Between groups differences in women behaviors
timeFrame: Within the second year of child life
measure: Between groups differences in Health literacy level
timeFrame: Immediately at the end of first trimester of pregnancy
measure: Between groups differences in Health literacy level
timeFrame: Immediately at the end of second trimester of pregnancy
measure: Between groups differences in Health literacy level
timeFrame: Within the second year of child life
measure: Between groups differences in social and health impact
timeFrame: Within the second year of child life
measure: Appreciation of the mHealth App
timeFrame: Within the second year of child life
measure: MHealth app usage data
timeFrame: Within the second year of child life
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Study officials:
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofolo
name: Tamara Stampalija, MD
role: PRINCIPAL_INVESTIGATOR
References: