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The Evira Study: Additional Support During Obesity Treatment

RecruitingNAAges 12 Years - 17 YearsAllKarolinska Institutet
NCT06836284 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate the effect of adding a digi-physical treatment tool as a complement to the local treatment with obesity medication in adolescents with obesity. The main question it aims to answer is: \- Can a combination of a digi-physical treatment tool and obesity medication improve treatment outcomes for patients with obesity compared to patients treated with obesity medications alone? This is a randomized controlled two-arm multicenter study where participants will be randomized to the intervention group (digi-physical treatment+medication) or control group (medication only). Participants will be followed for six months.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Digi-physical treatment tool, Evira
  • Obesity medication with liraglutide or semaglutide
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Where

3 sites
HKH Crown Princess Victoria's Childrens and youth Hospital Linköping
Linköping, Sweden
Länsverksamhet Barn- och ungdomsmedicin Sollefteå
Sollefteå, Sweden
Ystad lasarett, Barn och ungdomsmedicinmottagningen
Ystad, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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