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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Digi-physical treatment tool, Evira
DeviceA digi-physical treatment tool named Evira will be used to provide behavioral treatment.
Obesity medication with liraglutide or semaglutide
DrugObesity medication with liraglutide or semaglutide according to the clinic's standard procedure
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Obesity medication liraglutide or semaglutide combined with digi-physical treatment EviraActive comparator 2 interventions
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in BMI SDS
Weight and height will be combined to report BMI in kg/m\^2 for analyzing change in BMI standard deviation score.
Time frame
From start of treatment to six months follow-upSecondary outcomes
1
Proportion achieving less favorable reduction in BMI SDS
Can the proportion of patients achieving less favorable outcomes than those reported in published studies (liraglutide BMI SDS reduction of -0.23 units, semaglutide BMI SDS reduction of -0.75 units after six months) be reduced by combining medication treatment with a digital treatment tool?
Time frame
From start of treatment to six months follow-up2
Treatment Adherence
What is the treatment effect in relation to compliance based on the number of home measurements, physical visits, and in-app messages in the intervention group?
Time frame
From start of treatment to six months follow-up3
Side effects
What is the incidence of potential side effects and treatment discontinuation?
Time frame
From start of treatment to six months follow-up4
Professionals perception of the digital tool
Questionnaires regarding how healthcare professionals perceive the use of the digital tool in combination with medication treatment including questions such as; does it facilitate your work? Does it take more or less time? (Evira specific questionnaire)
Time frame
From start of treatment to six months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Evira AB
Collaborator
Source ClinicalTrials.gov