[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484615":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":62,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Aga Khan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","m-health coaching application",[13],"Behavioral: First diet: m-health coaching application",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","ACTIVE_COMPARATOR","Face to face counselling",[19],"Behavioral: Face to Face counselling",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","First diet: m-health coaching application","Intervention for the study would comprise of a culturally appropriate m-health application called first diet. This application will be developed considering the perceptions, barriers and facilitators identified through formative research. Content of the messages would focus on breastfeeding, its importance and early initiation within one hour of birth, significance of first feed i.e. colostrum, importance of EBF from birth till 6 months, introduction of complementary feeding to 6-8 months old infants and appropriate YCFP. These messages would be drafted in the local preferable language assessed during formative research. The content of the messages would be translated and then back translated to ensure validity. These messages will be short, contextual and tailored according to the women's stage of gestation, delivery and infant's age",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Face to Face counselling","Women randomly enrolled in the non-interventional group will receive face-face nutritional counseling instead of mobile application. Once enrolled in the group, Research Assistant (RA) will collect relevant details on the baseline questionnaire like intervention group but on a paper-based questionnaire. Women will be given first face-face counseling on the day of enrollment. The counseling sessions will coincide with the routine vaccination and growth monitoring schedule of the infant after women deliver",[15],[32],{"name":33,"affiliation":34,"role":35},"Rozina Nuruddin, PhD","Agha Khan University","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+923331288584","rozina.nuruddin@aku.edu",{"name":33,"role":38,"phone":26,"phoneExt":26,"email":40},[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"The Aga Khan University","RECRUITING","Karachi","Sindh","74000","Pakistan","PK",{"type":52,"coordinates":53},"Point",[54,55],67.0104,24.8608,{"lat":55,"lon":54},[58],{"name":59,"role":38,"phone":60,"phoneExt":61,"email":40},"Rozina Nuruddin Associate Professor, PhD","+92 21 3493 0051","4833",{"type":35,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Rozina Nuruddin","Associate Professor","100484615","efficacy-of-mobile-health-application-in-promotion-of-exclusive-breast-feeding-and-young-child-feeding-practices-in-pakistan-100484615",false,"NCT05590351","Efficacy of Mobile Health Application in Promotion of Exclusive Breast Feeding and Young Child Feeding Practices in Pakistan","Efficacy of Mobile Health Application in Promotion of Exclusive Breast Feeding and Young Child Feeding Practices in Pakistan: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Pregnant women in the third trimester at 36 +\u002F- 1 week of gestation.\n2. Planned to stay in their respective areas for at least 1 year after delivery\n3. Planned to get the infant immunized from the respective FHC of the hospitals.\n4. Have access to smart phones with internet connection.\n5. Registered and planning to deliver to any of the Secondary Care Hospitals\n6. Can read and write in local language (English and\u002For Urdu).\n7. Consent to participate and remain in the study until 1 year of child age\n\nExclusion Criteria:\n\n1. High-risk including maternal neurological\u002Fheart\u002F autoimmune\u002Frenal disease, preeclampsia, placenta previa, multiple gestations (twins\u002Ftriplets), fetal structural\u002Fgenetic anomalies, fetal growth restrictions, and birth trauma\u002Frequiring NICU admission.\n2. Women who plan to move to different location after delivery",true,"FEMALE","18 Years","48 Years",{"count":77,"type":78},300,"ESTIMATED","INTERVENTIONAL",[81],"NA","Early life nutrition is the key modifiable determinant of child growth, development, survival and diseases of adult onset. Pakistan ranks highest for neonatal mortality rate (44.2\u002F1000 live births (LBs)) globally. One third of under-five deaths (74.9\u002F1000 LBs) are attributable to high prevalence of stunting (38%), underweight (23%) and wasting (7%), greatly related to feeding practices. Given the low prevalence of exclusively breast fed (EBF) (48%) and use of minimum acceptable diet (13%), mitigation of early life nutritional risk through promotion of EBF and Young Child Feeding Practices (YCFP) provides a critical window of opportunity for intervention. Secondary Care Hospitals (SCH) of the Aga Khan Health Services Pakistan provide essential maternal and child health services for low-middle income population. Babies born at these SCHs are followed up for vaccination, growth-monitoring and other services at the closely affiliated Family Health Centers (FHCs) run by Lady Health Visitors (LHVs). We aim to examine the effectiveness of a locally designed m-Health application for empowering mothers for child nutritional care as a potentially sustainable approach. The first six months of formative research would identify perceptions, barriers and facilitators for EBF and YCFP using self-determination behavioral theory, among multi-parous pregnant mothers enrolled at three SCHs of Karachi. A randomization trial would be conducted during next 18 months among near-term pregnant women who have access to smart-phones. A culturally appropriate mhealth application called first diet would be developed to provide personalized push messages delivered weekly by the LHVs. Non-intervention group will receive face-face nutritional counselling by the research staff at FHC following routine vaccination and growth-monitoring schedule. Mothers would followed-up from one month prior to expected delivery to child's first birthday. We expect 20% improvement in rates of EBF and YCFP with m-Health intervention. If proven effective, m-health would be incorporated in routine child care provision by LHVs.",[84,85],"Malnutrition, Infant","Malnutrition, Child",[87,88,89],"infant & young child feeding practices","stunting","wasting","2026-02-10",{"date":92,"type":93},"2026-02-12","ACTUAL",{"date":95,"type":93},"2026-02-02",{"date":97,"type":78},"2027-12",{"name":5,"class":6},1]