The Evira Study: Additional Support During Obesity Treatment

April 29, 2026 updated by: Pernilla Danielsson, Karolinska Institutet

Evaluation of a Digital Treatment Tool in Combination With Obesity Medications

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Obesity is a complex and multifactorial disease, highlighting the need to develop treatment strategies that achieve more sustainable and effective outcomes. Treatments with the medications liraglutide and semaglutide have been tested, showing effects of -0.23 and -1.10 BMI SDS units, respectively, after approximately one year in individuals aged 12-17 years. These results are significantly better than those achieved with conventional treatment, where the effect for adolescents over 12 years is close to zero. However, long-term results indicate that many patients, after discontinuing medication, quickly return to the same degree of obesity they had at the start of the study.

Obesity medications can be effective for many patients, but challenges remain in achieving better treatment outcomes for more individuals. This underscores the need to evaluate whether the effect can be optimized by combining medication with digital treatment tools.

Evira is a digital treatment tool that enables close monitoring of objective treatment outcomes and continuous communication between healthcare professionals and families. The tool includes daily measurements conducted in the home of the patient on a measuring device that do not display any numbers. The device is linked to a mobile app where weight trends are displayed as a moving average in the form of BMI standard deviation score (BMI SDS). The app also provides an individualized target curve, visualizing the expected weight trajectory. Since weight changes in growing children are complex to interpret, BMI SDS is used as a standard metric. Objective data from the measuring device are also automatically transmitted to a clinic interface, enabling direct communication between the clinic and the family via the app.

This study is a randomized controlled two-arm multicenter trial conducted across multiple centers in Sweden that use liraglutide and semaglutide. Patients will be randomized in a 2:1 ratio, with two-thirds allocated to the intervention group and receiving medications combined with the Evira digital treatment tool, and one-third allocated to the control group, receiving medications with standard clinic support. Patients will be followed for six months. Data collection will include physical examinations, background information, and electronically distributed questionnaires administered to both groups.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Linköping, Sweden
        • Recruiting
        • HKH Crown Princess Victoria's Childrens and youth Hospital Linköping
        • Contact:
      • Ystad, Sweden
        • Recruiting
        • Ystad lasarett, Barn och ungdomsmedicinmottagningen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Patients randomized to this group will receive liraglutide or semaglutide treatment according to the clinic's standard procedures.
Drug: Obesity medication with liraglutide or semaglutide
Obesity medication with liraglutide or semaglutide according to the clinic's standard procedure
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.
Device: Digi-physical treatment tool, Evira
A digi-physical treatment tool named Evira will be used to provide behavioral treatment.
Drug: Obesity medication with liraglutide or semaglutide
Obesity medication with liraglutide or semaglutide according to the clinic's standard procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI SDS
Time Frame: From 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.
From start of treatment to six months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion achieving less favorable reduction in BMI SDS
Time Frame: From start of treatment to six months follow-up
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?
From start of treatment to six months follow-up
Treatment Adherence
Time Frame: From start of treatment to six months follow-up
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?
From start of treatment to six months follow-up
Side effects
Time Frame: From start of treatment to six months follow-up
What is the incidence of potential side effects and treatment discontinuation?
From start of treatment to six months follow-up
Professionals perception of the digital tool
Time Frame: From start of treatment to six months follow-up
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)
From start of treatment to six months follow-up
Patients perception of the treatment and digital tool
Time Frame: From start of treatment to six months follow-up
Questionnaire regarding how patients perceive the treatment and support received during the study, including questions such as; did you get enough and timely support from your healthcare provider? (Evira constructed questionnaire)
From start of treatment to six months follow-up
Patients Quality of life
Time Frame: From start of treatment to six months follow-up

How do patients rate their quality of life before, during, and after the study period? Are there differences between the intervention and control groups?

PROMIS version Pediatric-25 Profile GenPop v3.0 will be used. The instrument contains six domains (see below) along with a single item on Pain Intensity (scoring 0-10, 0=no pain, 10=worst pain).

T-scores are used to assess the health domains, a T-score of 50 represents the average with a standard deviation of 10.

For negatively-worded domains (Anxiety, Depressive Symptoms, Fatigue and Pain Interference), higher T-scores indicate worse health status.

For positively-worded domains (Physical Function-Mobility and Peer Relationships), higher T-scores indicate better health status.
From start of treatment to six months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Evira AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-07214-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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