NCT04917601Recruiting
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)
Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 680 (estimated)
- First submitted
- 2 Jun 2021
- Start date
- 24 May 2022
- Primary completion date
- Dec 2027
- Lead sponsor
- Karolinska Institutet
- Diseases
- Obesity
- NCT number
- NCT04917601
What you commit to
- Study type: Interventional
- Planned participants: 680
- From 24 May 2022 to the primary completion date, Dec 2027
- 5 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment for depression and other psychiatric disorders during the last 6 months before inclusion
- Eating disorders requiring therapy during the last six months before inclusion or observed at the inclusion screening.
Other illness
- Endocrine disorders other than well controlled hypothyroidism
- Metabolic disorders of importance for weight control - to be discussed
- Hypothalamic or monogenic obesity, e.g. syndromes and Mb Down
- Severe neuropsychiatric disorders that could affect study compliance
Age
- Morbid obesity defined as iso-BMI\>40kg/m2 independently of age
Other
- Pharmacological treatment of importance for weight control
Who the study is looking for
- 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
Age in the registry: 4 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Messina Coordinator of this site? Confirm its status | Messina | Italy | Not yet recruiting |
| University of Campania "Luigi Vanvitelli" Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| St Olavs Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Active, not recruiting |
| Samodzielny Publiczny Szpital Kliniczny Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Kalmar barnklinik Coordinator of this site? Confirm its status | Kalmar | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.