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The Evira Study: Additional Support During Obesity Treatment

RecruitingNA

Sponsor: Karolinska Institutet

Conditions: Childhood Obesity, Treatment Adherence

Interventions: Digi-physical treatment tool, Evira, Obesity medication with liraglutide or semaglutide

Countries: Sweden

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (3)

Linköping, Sweden
Sollefteå, Sweden
Ystad, Sweden