A Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment
Recruiting · NCT04917601 · Interventional (participants receive a specific treatment) · Lead sponsor: Karolinska Institutet
View the official record on ClinicalTrials.gov →Interventions studied
Evira Care treatmentStandard Lifestyle Care
What this trial is about
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.
Who can take part
Age range
4 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Parents having a smart phone and an email address
Exclusion criteria
- 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
- Pharmacological treatment of importance for weight control
- Hypothalamic or monogenic obesity, e.g. syndromes and Mb Down
- Severe neuropsychiatric disorders that could affect study compliance
- Eating disorders requiring therapy during the last six months before inclusion or observed at the inclusion screening.
Where it is running
5 locations listed.
- Kalmar barnklinik - Kalmar, Sweden
- University of Messina - Messina, Italy
- University of Campania Luigi Vanvitelli - Naples, Italy
- Samodzielny Publiczny Szpital Kliniczny - Szczecin, Poland
- St. Olavs Hospital - Trondheim, Norway