NCT05500339

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	M-health App	Pregnant women receive the App designed for the support of the first 1000 days of life
OTHER	Standard care	Pregnant women receive standard supportive and educational methods.

Timeline

• Start date: 2022-11-22
• Primary completion: 2024-05-31
• Completion: 2024-12-31
• First posted: 2022-08-15
• Last updated: 2024-03-18

Locations

1 site across 1 country: Italy