The Evira Study: Additional Support During Obesity Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorKarolinska Institutet
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Digi-physical treatment tool, Evira
- Obesity medication with liraglutide or semaglutide
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Karolinska Institutet
Lead sponsor
Evira AB
Collaborator
Source ClinicalTrials.gov