Childhood Obesity Clinical Trial
— EurEviraOfficial title:
A Randomized Controlled Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment (EurEvira)
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.
Status | Recruiting |
Enrollment | 680 |
Est. completion date | June 2026 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Robert Debré | Paris | |
Italy | University of Messina | Messina | |
Italy | University of Campania Luigi Vanvitelli | Naples | |
Norway | Oslo University Hospital | Oslo | |
Norway | St. Olavs Hospital | Trondheim | |
Sweden | Kalmar barnklinik | Kalmar |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Evira AB, Lund University |
France, Italy, Norway, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in degree of obesity | Measured by BMI standard deviation score. Support system users vs. control | Baseline, 12-month follow-up | |
Secondary | Treatment compliance | Measured by number of physical visits, cancellations, Evira weighings, communication through the system and no-shows | Baseline, 12-month follow-up | |
Secondary | Psycho-social health measures | Psycho-social health assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. The PROMIS questionnaire is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The output from a PROMIS score is represented as a T-score. Higher scores indicate more of the domain being measured (e.g., more fatigue, more pain). | Baseline, 12-month follow-up |
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