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The Evira Study: Additional Support During Obesity Treatment

Sponsor: Karolinska Institutet • ClinicalTrials.gov ID: NCT06836284

Registry updated: 2026-09-10

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Description

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.

Interventions

Digi-physical treatment tool, Evira (Device)
A digi-physical treatment tool named Evira will be used to provide behavioral treatment.
Obesity medication with liraglutide or semaglutide (Drug)
Obesity medication with liraglutide or semaglutide according to the clinic's standard procedure

Eligibility 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.

Conditions

Childhood Obesity Treatment Adherence

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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