Digital support system for treating childhood obesity
Official title: A Randomized Controlled Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment (EurEvira)
Run by Karolinska Institutet · NCT04917601 · Data updated 2026-11-12
This study tests if a new digital support system called Evira can help kids aged 4 to 17 manage their weight better when combined with regular lifestyle treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 17 Years |
| Sex | All |
| Enrollment | 680 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 5 sites (Messina and 4 other locations) |
| Status | Recruiting |
| Started | May 24, 2022 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 6, 2025 |
| Trial ID | NCT04917601 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 4 to 17 years with obesity defined by a BMI of 30 to 40 kg/m2.
✕Probably not a fit
Patients with morbid obesity (BMI > 40 kg/m2) or certain endocrine and metabolic disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of Evira, a digital support system designed to assist in the treatment of childhood obesity. It involves daily self-monitoring of weight through a special scale and a mobile app that facilitates communication between parents and clinicians. The study aims to determine if adding Evira to existing lifestyle treatment improves weight management outcomes for children aged 4 to 17 years. Participants will be randomly assigned to receive either the Evira Care treatment or standard lifestyle care.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the management of childhood obesity, leading to better health outcomes for affected children.
How similar studies have gone: Other studies have shown promise in using digital health interventions for obesity management, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
University of Campania Luigi Vanvitelli
Naples, Italy Recruiting -
Samodzielny Publiczny Szpital Kliniczny
Szczecin, Poland Recruiting -
University of Messina
Messina, Italy Not yet recruiting -
St. Olavs Hospital
Trondheim, Norway Active not recruiting -
Kalmar barnklinik
Kalmar, Sweden Completed
Study contacts
- Principal investigator: Pernilla Danielsson, PhD — Karolinska Institutet
- Study coordinator: Pernilla Danielsson Liljeqvist, Associate Professor
- Email: pernilla.danielsson-liljeqvist@regionstockholm.se
- Phone: +46 708 377734
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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E-health intervention for preventing childhood obesity
This study is testing whether an app for parents can help kids aged 6-12 who are overweight learn healthier habits and improve their overall well-being.
-
Personalized Addiction Treatment Enhancement for Opioid Use Disorder
A digital platform run by peer recovery supporters will be tested to help adults with opioid use disorder who are on buprenorphine or methadone stay in treatment and improve outcomes.
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Progressive Neuromuscular Stabilization vs. Aerobic Exercise for Obesity in Children
This study tests whether technology-assisted progressive neuromuscular stabilization exercises can improve body composition and balance in children with obesity, compared with standard aerobic exercise.
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Connecting Loved Ones to Support and Empower Recovery
A web-based program called KulaMind-Recovery tests whether guided online training, one-on-one coaching, and a community forum help loved ones support someone with a substance use disorder.
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MRI study to see how obesity treatments affect body and organ fat in severely obese kids
This study tests whether adding a GLP-1 receptor agonist to lifestyle changes helps improve body composition and organ fat in adolescents with severe obesity.
-
Bottle flow-rate test for babies and feeding patterns
This study tests whether different bottle nipple flow rates affect how much milk a 4–6 month old infant drinks, how they feed, and their sleep, by watching 220 mother–infant pairs.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.