Evira: digital support added to obesity medication for teens
Evaluation of a Digital Treatment Tool in Combination With Obesity Medications
This study will try adding the Evira digital tool to obesity medication for 12–17-year-olds to see if it improves weight outcomes and sticking with treatment compared with medication alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Linköping and 1 other locations) |
| Trial ID | NCT06836284 on ClinicalTrials.gov |
What this trial studies
This is a randomized, two-arm multicenter trial in which adolescents aged 12–17 receiving liraglutide or semaglutide are assigned to medication alone or medication plus the Evira digi-physical tool. Evira combines a home measuring device (that hides raw numbers) with a mobile app that shows BMI SDS trends as a moving average and an individualized target curve, plus continuous communication between families and clinicians. Participants will take part for six months with regular monitoring of weight trajectories and adherence. The study aims to determine whether close home monitoring and digital support improve short-term treatment response and engagement compared with medication alone.
Who should consider this trial
Good fit: Adolescents aged 12–17 who are being offered liraglutide or semaglutide at participating clinics and whose families agree to join the study are the intended candidates.
Not a fit: Patients with endocrine disorders beyond well-controlled hypothyroidism, recent or active eating disorders, severe neuropsychiatric conditions affecting adherence, hypothalamic or monogenic obesity, certain genetic syndromes, or other conditions making participation inappropriate may not benefit from this approach.
Why it matters
Potential benefit: If successful, adding Evira to medication could help adolescents achieve better weight change and stay engaged with treatment for longer.
How similar studies have performed: Previous trials of liraglutide and semaglutide in 12–17-year-olds showed meaningful short-term BMI SDS reductions but weight often returns after stopping medication, while digital adjuncts are promising but less extensively tested in adolescents.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients offered liraglutide or semaglutide in accordance with the clinic's routines. * Aged 12-17 years at the time of inclusion. * The family agrees to participate in a clinical study. Exclusion Criteria: * Endocrine disorders other than well-controlled hypothyroidism. * Severe neuropsychiatric disorders that may affect adherence to the study. * Eating disorder requiring treatment within the last six months before inclusion or observed during screening prior to inclusion. * Somatic conditions that may complicate the evaluation of treatment outcomes, such as patients on irregular oral corticosteroid treatment. * Hypothalamic or monogenic obesity, and genetic syndromes such as Down syndrome. * Patients deemed unsuitable for participation by the responsible physician.
Where this trial is running
Linköping and 1 other locations
- HKH Crown Princess Victoria's Childrens and youth Hospital Linköping — Linköping, Sweden (Recruiting)
- Ystad lasarett, Barn och ungdomsmedicinmottagningen — Ystad, Sweden (Recruiting)
Study contacts
- Study coordinator: Pernilla Danielsson Liljeqvist, Associate Professor
- Email: pernilla.danielsson.liljeqvist@ki.se
- Phone: 070-837 7734
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.