[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454789":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":12,"centralContacts":12,"locations":33,"responsibleParty":72,"collaborators":74,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":12,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":36,"whyStopped":12,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Swiss Tropical & Public Health Institute","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","Families in the control group will not receive any interventions and will simply complete baseline and endline surveys.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Home visits","EXPERIMENTAL","Families in the home visiting arm will receive visits by trained child development agents every two weeks between enrollment and 2 years of age.",[18],"Behavioral: Home visits",{"label":20,"type":15,"description":21,"interventionNames":22},"Afini","Families in the Afini arm will be introduced to the Afini app on Messenger and encouraged to use this platform throughout the study.",[23],"Other: Afini App",[25,29],{"type":26,"name":14,"description":27,"armGroupLabels":28,"otherNames":12},"BEHAVIORAL","Home visits entail a visit a children's home every two weeks. During this visit, trained child development agents will engage parents in activities with the child and provide basic toys and learning materials.",[14],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":12},"Afini App","Afini is an app designed to help parents provide nurturing environments and stimulation to their young children. Most caregivers currently connect to the platform via Facebook Messenger; once they sign up, the platforms start engaging the caregiver by recommending age-specific health- and development-promoting activities. Rather than just hoping that caregivers will later engage in these activities, the virtual assistant directly observes whether caregivers access the materials for the recommended activity, and asks caregivers to provide feedback on each task.",[20],[34,52],{"facility":35,"status":36,"city":37,"state":12,"zip":12,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Cayetano Heredia University","RECRUITING","Lima","Peru","PE",{"type":41,"coordinates":42},"Point",[43,44],-77.02824,-12.04318,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":12,"email":51},"Stella Hartinger, PhD","CONTACT","+51 13190000","stella.hartinger.p@upch.pe",{"facility":53,"status":36,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Swiss Tropical and Public Health Institute","Basel","Canton of Basel-City","4051","Switzerland","CH",{"type":41,"coordinates":60},[61,62],7.57327,47.55839,{"lat":62,"lon":61},[65,69],{"name":66,"role":49,"phone":67,"phoneExt":12,"email":68},"Günther Fink, PhD","+4161284-0","guenther.fink@swisstph.ch",{"name":70,"role":49,"phone":67,"phoneExt":12,"email":71},"Daniel Mäusezahl, PhD","daniel.maeusezahl@swisstph.ch",{"type":73,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[75,77,79],{"name":76,"class":6},"Harvard University",{"name":78,"class":6},"ETH Zurich (Switzerland)",{"name":80,"class":6},"Universidad Peruana Cayetano Heredia","100454789","digital-support-systems-to-improve-child-health-and-development-in-peru-100454789",false,"NCT05202106","Digital Support Systems to Improve Child Health and Development in Peru","Digital Support Systems to Improve Child Health and Development in Peru - a Randomized Controlled Trial","DigitalECD","Inclusion Criteria:\n\n* children residing in the study area\n\nExclusion Criteria:\n\n* children with disabilities\n* families planning to leave study area\n* families participating in national Cuna Mas program","ALL","3 Months","9 Months",{"count":93,"type":94},2400,"ESTIMATED","INTERVENTIONAL",[97],"NA","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.",[100],"Child Development",[102,103,104,105],"child development","stimulation","mobile phones","digital interventions","2025-05-14",{"date":108,"type":109},"2025-05-18","ACTUAL",{"date":111,"type":109},"2021-09-01",{"date":113,"type":94},"2026-06-30",{"name":5,"class":6},2]