Digital support system for treating childhood obesity
A Randomized Controlled Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment (EurEvira)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 680 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 5 sites (Messina and 4 other locations) |
| Trial ID | NCT04917601 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 17 years with obesity defined by a BMI of 30 to 40 kg/m2.
Not a fit: Patients with morbid obesity (BMI > 40 kg/m2) or certain endocrine and metabolic disorders may not benefit from this study.
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 performed: Other studies have shown promise in using digital health interventions for obesity management, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Messina and 4 other locations
- University of Messina — Messina, Italy (Not_yet_recruiting)
- University of Campania Luigi Vanvitelli — Naples, Italy (Recruiting)
- St. Olavs Hospital — Trondheim, Norway (Active_not_recruiting)
- Samodzielny Publiczny Szpital Kliniczny — Szczecin, Poland (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.