Childhood ObesityNCT06836284
The Evira Study: Additional Support During Obesity Treatment
A study testing Digi-physical treatment tool, Evira and Obesity medication with liraglutide or semaglutide in people with Childhood Obesity and Treatment Adherence, run by Karolinska Institutet at 3 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Childhood Obesity, Treatment Adherence
- What is being tested?
- Digi-physical treatment tool, Evira and Obesity medication with liraglutide or semaglutide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesSweden
- Study dates
- 13 Feb 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pernilla Danielsson Liljeqvist, Associate Professor contact
Sweden3 sites, 3 recruiting
- Recruiting
HKH Crown Princess Victoria's Childrens and youth Hospital Linköping
Linköping
Pär Andersson White, Medical doctor, 010-103 00 00 ext. 46, par.andersson.white@liu.se
- Recruiting
Länsverksamhet Barn- och ungdomsmedicin Sollefteå
Sollefteå
Annelie Thorén, MD, 0620-191 67 ext. +46, annelie.thoren@rvn.se
- Recruiting
Ystad lasarett, Barn och ungdomsmedicinmottagningen
Ystad
Annika Håkansson Rönnholm, RN, 0411-99 51 40 ext. 46, annika.hakanssonhonnholm@skane.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Obesity, Treatment Adherence
- Being tested
- Digi-physical treatment tool, Evira, Obesity medication with liraglutide or semaglutide
- Keywords
- Mobile Health, Self-Monitoring, Digital Treatment, Anti-Obesity Medication
- Medical subject headings
- Pediatric Obesity, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digi-physical treatment tool, EviraDevice
A digi-physical treatment tool named Evira will be used to provide behavioral treatment.
Obesity medication with liraglutide or semaglutideDrug
Obesity medication with liraglutide or semaglutide according to the clinic's standard procedure
| Study group | Role | What they receive |
|---|---|---|
| Obesity medication liraglutide or semaglutide combined with digi-physical treatment Evira | Active comparator | 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. Receives: Device: Digi-physical treatment tool, Evira; Drug: Obesity medication with liraglutide or semaglutide |
| Control group | Other | Patients randomized to this group will receive liraglutide or semaglutide treatment according to the clinic's standard procedures. Receives: Drug: Obesity medication with liraglutide or semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of treatment to six months follow-up
Secondary outcomes (6)
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?
Measured: From start of treatment to six months follow-up
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?
Measured: From start of treatment to six months follow-up
Side effects
What is the incidence of potential side effects and treatment discontinuation?
Measured: From start of treatment to six months follow-up
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)
Measured: From start of treatment to six months follow-up
Patients perception of the treatment and digital tool
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)
Measured: From start of treatment to six months follow-up
Patients Quality of life
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.
Measured: From start of treatment to six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start13 Feb 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Evira AB
- Responsible party
- Principal investigator, Pernilla Danielsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836284
- Sponsor's protocol ID
- 2024-07214-01
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Digital Treatment Tool in Combination With Obesity Medications
- ClinicalTrials.gov ID
- NCT06836284
- Acronym / sponsor ID
- 2024-07214-01
- Conditions
- Childhood Obesity, Treatment Adherence
- Keywords
- Mobile Health, Self-Monitoring, Digital Treatment, Anti-Obesity Medication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Evira AB
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity medication liraglutide or semaglutide combined with digi-physical treatment Evira | Active comparator | Device: Digi-physical treatment tool, Evira, Drug: Obesity medication with liraglutide or semaglutidePatients 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. |
| Control group | Other | Drug: Obesity medication with liraglutide or semaglutidePatients randomized to this group will receive liraglutide or semaglutide treatment according to the clinic's standard procedures. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digi-physical treatment tool, EviraA digi-physical treatment tool named Evira will be used to provide behavioral treatment. | Device | Obesity medication liraglutide or semaglutide combined with digi-physical treatment Evira |
| Obesity medication with liraglutide or semaglutideObesity medication with liraglutide or semaglutide according to the clinic's standard procedure | Drug | Control group, Obesity medication liraglutide or semaglutide combined with digi-physical treatment Evira |
Primary outcome
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.
6 secondary outcomes
Proportion achieving less favorable reduction in BMI SDS
Time frame: From start of treatment to six months follow-up
Treatment Adherence
Time frame: From start of treatment to six months follow-up
Side effects
Time frame: 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
Patients perception of the treatment and digital tool
Time frame: From start of treatment to six months follow-up
Patients Quality of life
Time frame: From start of treatment to six months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Childhood Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
Active, not recruiting
AIRWEIGHS: Investigating Obesity as a Susceptibility Factor for Air Pollution in Childhood Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pernilla Danielsson Liljeqvist, Associate Professor contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digi-physical treatment tool, Evira and Obesity medication with liraglutide or semaglutide in people with Childhood Obesity and Treatment Adherence, run by Karolinska Institutet at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pernilla Danielsson Liljeqvist, Associate Professor (070-837 7734 ext. 46, pernilla.danielsson.liljeqvist@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI SDS (time frame: From start of treatment to six months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.