[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100432744":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":18,"locations":30,"responsibleParty":42,"collaborators":18,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":18,"enrollmentInfo":55,"targetDuration":18,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","The app is explained and installed during the recruitment to the family in the intervention group. Some families in this group will be selected to take part to the qualitative research.",[13],"Device: CoSIE app",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Every months during the first year of study a newsletter is sent only to the members of the control group.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","CoSIE app","The app is a mobile phone application compatible with both iOS and Android operating system. Parents are able to register their children and to keep track of their weight status and activities. The app include five themes: child development, physical activity, healthy food, critical situations, BMI.\n\nPush notification on healthy behaviours, on important event taking place in the province of Reggio Emilia, on food advices based on seasonality and on party tips are constantly delivered by the app.",[9],[26],{"name":27,"affiliation":28,"role":29},"Paolo Giorgi Rossi, phd","Azienda USL-IRCCS Reggio Emilia","PRINCIPAL_INVESTIGATOR",[31],{"facility":28,"status":18,"city":32,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":18},"Reggio Emilia","42123","Italy","IT",{"type":37,"coordinates":38},"Point",[39,40],10.63125,44.69825,{"lat":40,"lon":39},{"type":43,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100432744","evaluation-of-the-efficacy-of-an-app-for-parents-to-promote-healthy-life-styles-in-children-the-cosie-trial-100432744",false,"NCT04915092","Evaluation of the Efficacy of an App for Parents to Promote Healthy Life-styles in Children: the CoSIE Trial","Co-creation of Service Innovation - Evaluation of the Efficacy of an App for Parents to Prevent Childhood Obesity and Promote Healthy Life-styles: CoSIE Randomized Controlled Trial","CoSIE","Inclusion Criteria:\n\n* parents of children aged 3 to 11 presneting for a new well child visit or for a sport medicin visit or presenting for a childhood obesity visit at the AUSL Reggio Emilia clinics, including family pediatricians clinics.\n\nExclusion Criteria:\n\n* Families resident outside the Province of Reggio Emilia\n* Parents with no comprehension of the Italian language\n* Children inside a program for obesity cure or prevention. The program are:\n\n  * the GET program (a program coordinated by the hospital pediatric unit in which obese children follow a group intervention),\n  * the BMInforma program (in which overweight girls from 5 to 7 years old follow a counselling proposed by the family paediatrician),\n  * the second level medical clinic in which obese children with pathologic condition are cured\n* Children with severe obesity previously diagnosed",true,"ALL","18 Years",{"count":56,"type":57},327,"ACTUAL","INTERVENTIONAL",[60],"NA","The objective of the study is to evaluate the effectiveness of the app in terms of changing lifestyles both related to nutrition and physical activity. The study is also aimed at evaluating the usability and the degree of acceptance of the app among parents.\n\nThe primary objective will be assessed in terms of the change in the consumption of sugary drinks and high-calorie food and in terms of time spent in front of a screen.\n\nThe secondary objectives are the evaluation of BMI (percentile and z-score) and waist circumference and the evaluation of the usability of the app.\n\nSTUDY DESIGN The study is a randomized control trial. Both parents and children are recruited.\n\n* Family paediatricians during the health balance of 3 or 5 years old (children between 3 and 6.5 years old)\n* Sport medicine during the visits for sport ability (children between 7 and 11 years old)\n* Pediatric Endocrinology and Diabetology of the Santa Maria Hospital during routine visits (children between 5 and 11 years old)\n\nWhen the study is presented to families, few clinical information are collected on the electronic platform designed for enrollment and randomization:\n\n* Child weight and height\n* Child waist circumference\n\nMore information about children and parents are collected (through questionnaire).\n\nThe families (both treatment and control ) are contacted after 12 month and after 24 months from the recruitment to answer to a questionnaire on lifestyle habits (food and physical activity) of the child and app utilization\n\nDuring this visit also child weight, height and waist circumference will be collected.\n\nIntervention group The app is explained and installed during the recruitment to the family in the intervention group.\n\nSome families in this group will be selected to take part to the qualitative research.\n\nControl group Every months during the first year of study a newsletter is sent only to the members of the control group.",[63],"Childhood Obesity",[65,66,67,68],"mhealth","app","obesity","prevention","COMPLETED","2025-06-20",{"date":72,"type":57},"2025-06-25",{"date":74,"type":57},"2021-06-14",{"date":76,"type":57},"2024-01-15",{"name":5,"class":6},1]