The Evira Study: Additional Support During Obesity Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digi-physical treatment tool, Evira, Obesity medication with liraglutide or semaglutide.
- Who it may be relevant to
- Registry conditions: Childhood Obesity, Treatment Adherence. Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of a Digital Treatment Tool in Combination With Obesity Medications
Overview
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.
Interventions
- 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
Primary outcome measures
- Change in BMI SDS [Time frame: From start of treatment to six months follow-up]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 2 centers
- HKH Crown Princess Victoria's Childrens and youth Hospital Linköping — Linköping
- Ystad lasarett, Barn och ungdomsmedicinmottagningen — Ystad
Identifiers
NCT: NCT06836284 · 2024-07214-01