Using a mobile health app to support pregnant women during their 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
This study tests whether a mobile health app can help pregnant women during their first 1000 days by providing support and information alongside regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 1 site (Trieste) |
| Trial ID | NCT05500339 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a mobile health application designed to support pregnant women during the critical first 1000 days of life, which includes pregnancy and the early years of a child's life. The intervention involves providing participants with access to the app alongside standard care, aiming to enhance health-related behaviors and information seeking. The study targets pregnant women in their first trimester who are willing to engage with the app and receive care at a specific health institute in Italy.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older who are fluent in Italian and have access to a smartphone.
Not a fit: Patients who are unable to provide informed consent or do not meet the language or technology requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve health outcomes for mothers and their children by promoting better health behaviors during pregnancy and early childhood.
How similar studies have performed: While mobile health applications have been widely used in pregnancy support, the specific effectiveness of this approach in the context of the first 1000 days is still being explored, making it a novel initiative.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Trieste
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste, Italy (Recruiting)
Study contacts
- Principal investigator: Tamara Stampalija, MD — Institute for Maternal and Child Health IRCCS Burlo Garofolo
- Study coordinator: Tamara Stampalija, MD
- Email: tamara.stampalija@burlo.trieste.it
- Phone: 040.3785.486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.