NCT05202106 Digital Support Systems to Improve Child Health and Development in Peru
| NCT ID | NCT05202106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Swiss Tropical & Public Health Institute |
| Condition | Child Development |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,400 participants in total. It began in 2021-09-01 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
About 250 million children under age five are at risk of not reaching their developmental potential due to continued exposure to ill health, malnutrition and lack of appropriate learning environments. A large number of initiatives have been launched in recent years to support early childhood development, with home visiting programs increasingly being recognized as a key strategy for improving child wellbeing. However, the most effective ways to reach families in low income settings remain unclear due to the large expense associated with personal family visits. This project assesses the effectiveness and equity of a newly developed digital platform designed to deliver evidence-based, individualized parenting support through automated services. The Afinidata platform uses state-of-the art machine learning algorithms to allow caregivers to get answers to questions about child health and development, while also identifying and promoting age- and development-appropriate activities for parents to support their children. The goal of this study is to rigorously assess the reach, impact and cost effectiveness of this digital platform in a poor rural population through a randomized controlled trial. The study is designed as mixed-methods evaluation approach with repeated feedback into the Afinidata system. A total of 2400 newborns will be enrolled in a randomized controlled trial in San Marcos, Peru, and followed up for two years. The primary study outcome will be children's healthy development at 24 months of age assessed through the Bayley Scales of Infant and Toddler Development (BSID-III). Secondary outcomes will be systems utilization, program coverage and cost-effectiveness, as well as caregiver satisfaction. If proven effective, this innovative digital platform may increase global access to low-cost parental support -a widely recognized key strategy for improving child well-being.
Eligibility Criteria
Inclusion Criteria: * children residing in the study area Exclusion Criteria: * children with disabilities * families planning to leave study area * families participating in national Cuna Mas program
Frequently Asked Questions
Who can join the NCT05202106 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 9 Months, studying Child Development. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05202106 currently recruiting?
Yes, NCT05202106 is actively recruiting participants. Visit ClinicalTrials.gov or contact Swiss Tropical & Public Health Institute to inquire about joining.
Where is the NCT05202106 trial being conducted?
This trial is being conducted at Lima, Peru, Basel, Switzerland.
Who is sponsoring the NCT05202106 clinical trial?
NCT05202106 is sponsored by Swiss Tropical & Public Health Institute. The trial plans to enroll 2,400 participants.