Effectiveness of a mHealth App for Supporting the First 1000 Days of Life (CARE1000)

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

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 Overview

• Status: Recruiting
• Conditions: Health-Related Behavior
• Intervention / Treatment: Other: M-health App; Other: Standard care

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamara Stampalija, MD; Phone Number: 040.3785.486; Email: tamara.stampalija@burlo.trieste.it

Study Locations

• Italy
  • Trieste, Italy, 34137
    • Recruiting
    • Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
    • Contact: Tamara Stampalija, MD PhD; Phone Number: +39.040.3785.486; Email: tamara.stampalija@burlo.trieste.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: M-health App; Pregnant women receive the App designed for the support of the first 1000 days of life
Sham Comparator: Standard care.; Pregnant women receive standard supportive and educational methods.	Other: Standard care; Pregnant women receive standard supportive and educational methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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	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	Within the second year of child life

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Principal Investigator: Tamara Stampalija, MD, Institute for Maternal and Child Health IRCCS Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: mHealth application; first 1000 days; health prevention
• Other Study ID Numbers: RC 04\2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No