The Evira Study: Additional Support During Obesity Treatment

Sponsor
Karolinska Institutet
Study ID
NCT06836284
Status
Recruiting
Apply to this trial

Conditions

  • Childhood Obesity
  • Treatment Adherence

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Feb 13, 2026
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Control group
    Patients randomized to this group will receive liraglutide or semaglutide treatment according to the clinic's standard procedures.
  • Active Comparator: Obesity medication liraglutide or semaglutide combined with digi-physical treatment Evira
    Patients randomized to this group will receive liraglutide or semaglutide in combination with a digi-physical treatment tool, named Evira. Patients will be provided with a digitless measuring scale intended for daily use at home. They will be able to communicate with clinical staff at pivotal moments.

Primary Outcome Measure

Change in BMI SDS [ Time Frame: From start of treatment to six months follow-up ]

Central Contacts

Related Studies