Clinical trial NCT06836284: The Evira Study: Additional Support During Anti-Obesity Treatment
Official title: Evaluation of a Digital Treatment Tool in Combination with Anti-Obesity Medications
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Childhood Obesity
Treatment Adherence
Keywords: Mobile Health
Self-Monitoring
Digital Treatment
Anti-Obesity Medication
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Evira AB
First posted: 2025-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 anti-obesity medication in adolescents with obesity. The main question it aims to answer is:

- Can a combination of a digi-physical treatment tool and anti-obesity medication improve treatment outcomes for patients with obesity compared to patients treated with anti-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.

Anti-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.

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.

Primary outcomes:
measure: Change in BMI SDS
timeFrame: From start of treatment to six months follow-up
Secondary outcomes:
measure: Proportion achieving less favorable reduction in BMI SDS
timeFrame: From start of treatment to six months follow-up
measure: Treatment Adherence
timeFrame: From start of treatment to six months follow-up
measure: Side effects
timeFrame: From start of treatment to six months follow-up
measure: Professionals perception of the digital tool
timeFrame: From start of treatment to six months follow-up
measure: Patients perception of the treatment and digital tool
timeFrame: From start of treatment to six months follow-up
measure: Patients Quality of life
timeFrame: From start of treatment to six months follow-up
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: HKH Crown Princess Victoria's Childrens and youth Hospital Linköping
Study officials:
References: