The Evira Study: Additional Support During Obesity Treatment
Recruiting · NCT06836284 · Interventional (participants receive a specific treatment) · Lead sponsor: Karolinska Institutet
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
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.
Where it is running
2 locations listed.
- HKH Crown Princess Victoria's Childrens and youth Hospital Linköping - Linköping, Sweden
- Ystad lasarett, Barn och ungdomsmedicinmottagningen - Ystad, Sweden