[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570296":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":61,"collaborators":63,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":18,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":18,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":47,"whyStopped":18,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Southern Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","The Bloom Intervention adds to standard municipal care (5-6 home visits) with a prenatal visit, visits at 18 and 30 months, up to eight phone consultations, parent groups, and a video library.\n\nHome visits: Three extra visits include one in pregnancy week 22-24 to build trust and assess needs using a dialogue tool focused on social and demographic factors. Visits at 18 and 30 months support sustained progress and address new challenges.\n\nPhone consultations: Up to eight calls support breastfeeding, bottle-feeding, and complementary feeding. Phone consultations at 12 and 24 months aid in maintaining healthy habits during key transitions, like starting daycare.\n\nParent groups: Encourage shared experiences among parents, with policies promoting father participation.\n\nVideo library: Includes 62 videos on nutrition, motor skills, sleep, etc., with 48 available in multiple languages for wider access.",[13],"Behavioral: Multi-behavioural",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","The families in the control municipalities will receive standard deliveries from the community health nurses",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Multi-behavioural","The Bloom Study is implemented in an existing and highly accepted health service delivered by community health nurses. Beyond focusing on food, meals, motor skills and movement, the intervention also target sleep and family sense of security. The intervention commence in pregnancy and continues until the child is 2½ years old.",[9],[26,27,28,29,30],"Motor skills and movement","Screen use","Sleep","Family sense of security","Food and meals",[32],{"name":33,"affiliation":5,"role":34},"Camilla T Bonnesen","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":18,"email":39},"CONTACT","+4565507883","catb@sdu.dk",{"name":41,"role":37,"phone":42,"phoneExt":18,"email":43},"Mette Rasmussen","+4565507319","mera@sdu.dk",[45],{"facility":46,"status":47,"city":48,"state":18,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"National Institute of Public Health, University of Southern Denmark","RECRUITING","Copenhagen","1455","Denmark","DK",{"type":53,"coordinates":54},"Point",[55,56],12.56553,55.67594,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":38,"phoneExt":18,"email":39},"Camilla T Bonnesen, Researcher",{"type":62,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[64,67,69,71,73],{"name":65,"class":66},"Danish Centre for Health Economics (DaCHE), University of Southern Denmark","UNKNOWN",{"name":68,"class":6},"University of Copenhagen",{"name":70,"class":66},"Danish Research Centre for Migration, Ethnicity and Health, University of Copenhagen",{"name":72,"class":66},"Centre for Childhood Health",{"name":74,"class":66},"The Centre for Health Economics, University of York","100570296","the-bloom-study---a-safe-and-healthy-start-in-life-100570296",false,"NCT06705400","The Bloom Study - a Safe and Healthy Start in Life","Inclusion Criteria:\n\nAll children born from first-time mothers being in gestation week 20 between November 1st 2024 and October 31st 2025.\n\nExclusion Criteria:\n\nNot being able to receive digital post.",true,"ALL","0 Months","6 Months",{"count":86,"type":87},3500,"ESTIMATED","INTERVENTIONAL",[90],"NA","The aim of the Bloom Study is to promote healthy weight development among infants through a home-based health promoting intervention implemented in the Danish setting of community health nurses. The intervention begins during pregnancy and runs until the child reaches the age of 30 months.\n\nThe Bloom Intervention was developed over a six-year period from 2017 to 2023 according to the Intervention Mapping approach and based on a co-creation process.\n\nThe Bloom Intervention is evaluated in a cluster-randomized trial involving 22 Danish municipalities (11 intervention and 11 control). All children born from first-time mothers over a period of 12 months are invited to participate.",[93,94],"Overweight, Childhood","Obesity in Children",[96,9,97,98,99,100,101,102,103,104,105,106,107,26,27,28],"The Bloom Study","Infants","Weight status","Community health nurses","Home-based","Randomized controlled trial","Children","Multi-component","Health promotion and prevention","Overweight","Obesity","Food habits and meals","2025-12-15",{"date":110,"type":111},"2025-12-22","ACTUAL",{"date":113,"type":111},"2024-11-01",{"date":115,"type":87},"2029-03-31",{"name":5,"class":6},1]