[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100432937":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":111,"collaborators":114,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":25,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":143,"overallStatus":59,"whyStopped":25,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Evira Care treatment","EXPERIMENTAL","The intervention arm will receive Evira Care in combination with Standard Lifestyle Care. If the standard treatment, after the first month of treatment, contains more frequent visits than every third month, the number of standard visits shall be reduced to a maximum of one visit every third month. During the first 2-4 weeks, participants will receive information about the system and how to utilize the daily weighings and communication system. The families will be informed about possible lifestyle changes that may be effective and that they are supposed to do lifestyle changes primarily regarding energy intake that they do consider feasible in their specific living situations.\n\nClinical investigations will be completed and includes physical and abdominal examinations, weight, height, and blood pressure. All participants will also be asked to answer questionnaires including quality of life, eating disorders, and treatment satisfaction.",[13],"Behavioral: Evira Care treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Lifestyle Care","ACTIVE_COMPARATOR","The control group will receive the standard care of treatment for childhood obesity, which addresses lifestyles without any restriction in visits or clinical support.\n\nClinical investigations will be completed and includes physical and abdominal examinations, weight, height, and blood pressure. All participants will also be asked to answer questionnaires including quality of life, eating disorders, and treatment satisfaction.",[19],"Behavioral: Standard Lifestyle Care",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","The intervention aim to examine the effectiveness of using a digital support system (Evira) in treatment of childhood obesity. Through daily weighings at home using a special designed scale, which sends data directly to an application on the parents phone and to a clinic homepage, the child's weight development can be easily monitored. Participants can be randomized to either the intervention group or the control group. The control group will receive local standard treatment.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The control group will receive the local standard care of treatment addressing lifestyles for childhood obesity without any restriction in visits or clinical support. This is the current standard care of treatment for childhood obesity.",[15],[30],{"name":31,"affiliation":5,"role":32},"Pernilla Danielsson, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Pernilla Danielsson Liljeqvist, Associate Professor","CONTACT","+46 708 377734","pernilla.danielsson-liljeqvist@regionstockholm.se",[40,57,71,83,99],{"facility":41,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of Messina","NOT_YET_RECRUITING","Messina","98125","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],15.55256,38.19394,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":25,"phoneExt":25,"email":56},"Domenico Corica, MD, PhD","domenico.corica@unime.it",{"facility":58,"status":59,"city":60,"state":25,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"University of Campania Luigi Vanvitelli","RECRUITING","Naples","80138",{"type":48,"coordinates":63},[64,65],14.26811,40.85216,{"lat":65,"lon":64},[68],{"name":69,"role":36,"phone":25,"phoneExt":25,"email":70},"Giuseppina Rosaria Umano, Dr.","giuseppinarosaria.umano@unicampania.it",{"facility":72,"status":73,"city":74,"state":25,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":82,"contacts":25},"St. Olavs Hospital","ACTIVE_NOT_RECRUITING","Trondheim","7030","Norway","NO",{"type":48,"coordinates":79},[80,81],10.39506,63.43049,{"lat":81,"lon":80},{"facility":84,"status":59,"city":85,"state":25,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Samodzielny Publiczny Szpital Kliniczny","Szczecin","71-252","Poland","PL",{"type":48,"coordinates":90},[91,92],14.55302,53.42894,{"lat":92,"lon":91},[95],{"name":96,"role":36,"phone":97,"phoneExt":25,"email":98},"Elzbieta Petriczko, Dr.","+48602731533","elzbieta.petriczko@pum.edu.pl",{"facility":100,"status":101,"city":102,"state":25,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":25},"Kalmar barnklinik","COMPLETED","Kalmar","391 85","Sweden","SE",{"type":48,"coordinates":107},[108,109],16.36163,56.66157,{"lat":109,"lon":108},{"type":32,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Pernilla Danielsson","Pediatric nurse, Associate Professor",[115,117],{"name":116,"class":6},"Lund University",{"name":118,"class":119},"Evira AB","INDUSTRY","100432937","a-multicenter-study-for-evaluating-a-digital-support-system-in-childhood-obesity-treatment-100432937",false,"NCT04917601","A Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment","A Randomized Controlled Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment (EurEvira)","EurEvira","Inclusion Criteria:\n\n* Age \\>4.0 and \\\u003C17.0 years of age at inclusion\n* Obesity defined based on the International Obesity Task Force criteria iso-BMI 30 - 40 kg\u002Fm2\n* Willingness to participate in an obesity treatment clinical trial\n* Family ability to communicate in the language of the country of residence e.g. write and read messages in the mobile application\n* Parents having a smart phone and an email address\n\nExclusion Criteria:\n\n* Morbid obesity defined as iso-BMI\\>40kg\u002Fm2 independently of age\n* Endocrine disorders other than well controlled hypothyroidism\n* Metabolic disorders of importance for weight control - to be discussed\n* Treatment for depression and other psychiatric disorders during the last 6 months before inclusion\n* Pharmacological treatment of importance for weight control\n* Hypothalamic or monogenic obesity, e.g. syndromes and Mb Down\n* Severe neuropsychiatric disorders that could affect study compliance\n* Eating disorders requiring therapy during the last six months before inclusion or observed at the inclusion screening.","ALL","4 Years","17 Years",{"count":132,"type":133},680,"ESTIMATED","INTERVENTIONAL",[136],"NA","Evira is a digital support system newly developed for treatment of childhood obesity. Through daily weighings at home using a special scale together with a message function in the Evira application, enabling fast and easy communication with the clinic, parents and the clinicians can easily follow the child's weight development. The purpose of this randomized controlled study is to evaluate the effect of adding Evira to the already locally used life-style treatment of childhood obesity.",[139,140,141,142],"Childhood Obesity","Adolescent Obesity","mHealth","Personalized Medicine",[144,145],"Obesity treatment","Digital support system","2025-09-30",{"date":148,"type":149},"2025-10-06","ACTUAL",{"date":151,"type":149},"2022-05-24",{"date":153,"type":133},"2027-12",{"name":5,"class":6},5]