Clinical trial

The Evira Study: Additional Support During Obesity Treatment

Recruiting now · Not applicable · 1 countries · Registry ID NCT06836284

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionChildhood Obesity, Treatment Adherence

Full registry 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.

Treatments and study arms

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

Primary outcomes

Change in BMI SDSFrom start of treatment to six months follow-up

Weight and height will be combined to report BMI in kg/m\^2 for analyzing change in BMI standard deviation score.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

HKH Crown Princess Victoria's Childrens and youth Hospital Linköping🇸🇪 Linköping, Sweden

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Pär Andersson White, Medical doctorContact

Email · Call 010-103 00 00

Ystad lasarett, Barn och ungdomsmedicinmottagningen🇸🇪 Ystad, Sweden

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Annika Håkansson Rönnholm, RNContact

Email · Call 0411-99 51 40