[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"families-with-infants\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:families-with-infants":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100588433","healthysteps--playreadvip-100588433",false,"NCT06941337","HealthySteps + PlayReadVIP","HEALTHYSTEPS + PLAYREADVIP EFFECTS ON PARENTING AND CHILD DEVELOPMENT: A RANDOMIZED IMPLEMENTATION EFFECTIVENESS TRIAL","Inclusion Criteria:\n\n* Parent is a biological parent or legal guardian and at least 18 years of age\n* Infants must be ≤6 months old at the time of enrollment.\n* Parents\u002Fguardians must speak either English or Spanish to ensure they can fully engage with the intervention and assessments.\n* Families must be identified as Tier 3 HealthySteps participants, indicating higher levels of need based on clinic screening for factors such as:Adverse Childhood Experiences (ACEs) and parenting challenges or vulnerabilities.\n* Parent is able to willing to provide consent for their own and their child's participation.\n\nExclusion Criteria:\n\n* Non-singleton child\n* Parent is unable to provide consent\n* Parent does not speak English or Spanish, as study materials (e.g., questionnaires) are available in those languages\n* Parent has a severe medical or psychiatric impairment (e.g., intellectual disability, psychosis) that would interfere with study participation\n* Parent has plans to discontinue care at NYU Langone Health - Sunset Park Family Health Centers",true,"ALL","6 Months",{"count":20,"type":21},1000,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to investigate the effectiveness and implementation outcomes for the integration of two evidence-based practices and interventions (EBPIs) within pediatric primary care settings: HealthySteps (HS), which provides parenting support, and PlayReadVIP, which promotes relational health through video coaching. Families will be randomized to receive either the integrated HS + PlayReadVIP model or traditional HS, and investigators will examine impacts on parenting, parent-child relationships, and child development, as well as feasibility, acceptability, and appropriateness of the integrated intervention.",[27],"Families With Infants","RECRUITING","2026-04-28",{"date":31,"type":32},"2026-05-04","ACTUAL",{"date":34,"type":32},"2025-06-09",{"date":36,"type":21},"2029-01",{"name":38,"class":39},"NYU Langone Health","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100633670","evaluation-of-a-multicomponent-early-intervention-for-childhood-obesity-prevention-in-vulnerable-families-100633670","NCT07529704","Evaluation of a Multicomponent Early Intervention for Childhood Obesity Prevention in Vulnerable Families","Evaluation of a Tailored Multicomponent Early Intervention for Childhood Obesity Prevention in Vulnerable Families (Bambú Project): Randomized Controlled Trial With a Hybrid Type 1 Effectiveness-implementation Design","Bambú","Inclusion Criteria:\n\n* Mothers and\u002For fathers aged 18 years or older.\n* Primary caregivers of a healthy child aged 6 months to 3 years, born at term (≥37 weeks of gestation).\n* At least one parent with overweight or obesity (as defined by BMI criteria).\n* Families in a situation of vulnerability, defined as meeting ≥2 of the following criteria: (1) Low educational level of at least one parent (≤ lower secondary education or equivalent); (2) Precarious employment situation during the past year, (3) Perceived financial difficulties during the past year; (4) Insecure or unstable housing conditions; (5) Single-parent family or prolonged absence of one of the primary caregivers; (6) Recent immigration (≤10 years) without a stable support network or with language barriers.\n\nExclusion Criteria:\n\n* Parents of a child aged 6 months to 3 years with low birth weight (\\\u003C2500 g)\n* Parents of a child aged 6 months to 3 years from a multiple birth (e.g., twins, triplets)\n* Parents\u002Fcaregivers of a child aged 6 months to 3 years with congenital conditions, chronic diseases, or severe disabilities that may affect feeding, growth, or participation in the study\n* Parents or caregivers with severe physical or mental health conditions that would limit their ability to participate in the intervention or assessments\n* Families planning to move out of the study area during the study period",{"count":50,"type":21},526,[24],"Childhood obesity is a public health concern. Evidence-based, multicomponent, parenting interventions targeting early childhood and adapted to families' socioeconomic context are needed to prevent childhood obesity.\n\nThis study aims to evaluate the effectiveness of an early intervention in primary care for the prevention of childhood obesity, targeting vulnerable families where the mother and\u002For the father has overweight or obesity.\n\nMore specifically, the primary aim of this study is to evaluate the effectiveness the intervention to maintain a healthy weight in children aged 6 months to 3 years, measured by the BMI-for-age z-score at baseline, 6, 12, and 18 months, compared to usual care.\n\nThe study also aims to evaluate the effectiveness of the intervention, compared to usual care, for: promoting responsive feeding, improving dietary intake, improving parents' and children's physical activity levels, improving parents' eating styles, and improving children's sleep.\n\nFinally, the study aims to determine the feasibility of implementing the intervention, and to identify factors influencing change and contextual factors in the implementation process.\n\nA pragmatic cluster randomized controlled trial will be conducted. Approximately 526 families (parent-child family dyads) will be recruited, belonging to 76 primary care centers. Primary care centers will be randomly assigned to either an intervention or control group.\n\nThe intervention has been previously co-designed with families and healthcare professionals, and consists of five weekly sessions and 4 monthly sessions, lasting 2 hours each. It will be delivered by previously trained healthcare professionals or by members of the research team, depending on the preferences and availability of the primary care center professionals. Approximately 38 intervention face-to-face groups will be conducted, one in each primary care center allocated to the intervention group.\n\nThe study will be conducted in Catalonia, Andalusia and the Balearic Islands (Spain).\n\nEffectiveness outcomes include child body mass index (BMI) z-score, parent feeding practices (measured with the Feeding Practices and Structure Questionnaire), child dietary intake (measured with the multiple-pass 24-hour recall), parents' eating behaviours (measured with the Dutch Eating Behavior Questionnaire), child movement (measured with the Movement Behavior Questionnaire), parents' movement behaviours (measured with the Brief Physical Activity Assessment Tool), and child sleep (measured with selected items from the Brief Infant Sleep Questionnaire).\n\nImplementation and feasibility outcomes will be assessed through interviews during and at the end of the intervention, and through attendance sheets and a final satisfaction questionnaire.\n\nThis study will provide pioneering insights into the implementation and effectiveness of this intervention within the public healthcare system in Spain. This will allow the potential implementation in the future at a larger scale.",[54,55,56,27],"Obesity & Overweight","Vulnerable Families","Children",[58,59,60,61,62,63,64],"Pediatric obesity","Prevention","Vulnerable populations","Randomized controlled trial","Primary health care","Early intervention","Parenting interventions","2026-04-07",{"date":67,"type":32},"2026-04-14",{"date":69,"type":32},"2026-03-02",{"date":71,"type":21},"2028-06",{"name":73,"class":39},"Helena Vall Roqué",3]