A Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
Qualifiers
Age >4.0 and <17.0 years of age at inclusion
Obesity defined based on the International Obesity Task Force criteria iso-BMI 30 - 40 kg/m2
Willingness to participate in an obesity treatment clinical trial
Family ability to communicate in the language of the country of residence e.g. write and read messages in the mobile application
Disqualifiers
Morbid obesity defined as iso-BMI>40kg/m2 independently of age
Endocrine disorders other than well controlled hypothyroidism
Metabolic disorders of importance for weight control - to be discussed
Treatment for depression and other psychiatric disorders during the last 6 months before inclusion
Trial design
Treatments tested in this trial
- Evira Care treatment
- Standard Lifestyle Care
Treatment groups
680 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov