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

NCT05500339 | Recruiting

• 1 other identifier: RC 04\2022
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Keywords

mHealth application; first 1000 days; health prevention

Outcome Measures

Primary Outcomes (1)

• Between 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

  Within the second year of child life

Secondary Outcomes (12)

• Between groups differences in women knowledge

  Immediately at the end of first trimester of pregnancy

• Between groups differences in women behaviors

  Immediately at the end of first trimester of pregnancy

• Between groups differences in women knowledge

  At the end of second trimester of pregnancy

• Between groups differences in women behaviors

  At the end of second trimester of pregnancy

• Between groups differences in women knowledge

  Within the second year of child life

Study Arms (2)

mHealth App

EXPERIMENTAL

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.

Other: M-health App

Standard care.

SHAM COMPARATOR

Pregnant women receive standard supportive and educational methods.

Other: Standard care

Interventions

M-health App OTHER

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

mHealth App

Standard care OTHER

Pregnant women receive standard supportive and educational methods.

Standard care.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Inability to give informed consent

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

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

Trieste, 34137, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 36510286 DERIVED

MeSH Terms

Conditions

Health Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tamara Stampalija, MD

  Institute for Maternal and Child Health IRCCS Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Stampalija, MD

CONTACT

040.3785.486; tamara.stampalija@burlo.trieste.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 15, 2022
• Study Start: November 22, 2022
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

IT (1)