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

NCT ID: NCT05500339

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2024-12-31

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.

Conditions

Health-Related Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

mHealth App

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.

Group Type: EXPERIMENTAL

M-health App

Intervention Type: OTHER

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

Standard care.

Pregnant women receive standard supportive and educational methods.

Group Type: SHAM_COMPARATOR

Standard care

Intervention Type: OTHER

Pregnant women receive standard supportive and educational methods.

Interventions

M-health App

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

Intervention Type: OTHER

Standard care

Pregnant women receive standard supportive and educational methods.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamara Stampalija, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Locations

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

Trieste, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Tamara Stampalija, MD

Role: CONTACT

tamara.stampalija@burlo.trieste.it

040.3785.486

Facility Contacts

Tamara Stampalija, MD PhD

Role: primary

tamara.stampalija@burlo.trieste.it

+39.040.3785.486

References

Brunelli L, Bussolaro S, Dal Cin M, Ronfani L, Zanchiello S, Cassone A, Verardi G, Dobrina R, Bava M, Stampalija T. CARE 1000: randomized controlled trial for the evaluation of the effectiveness of a mHealth app for supporting the first 1000 days of life. Trials. 2022 Dec 12;23(1):1007. doi: 10.1186/s13063-022-06953-y.

Reference Type: DERIVED

PMID: 36510286 (View on PubMed)

Other Identifiers

RC 04\2022

Identifier Type: -

Identifier Source: org_study_id