The Evira Study: Additional Support During Obesity Treatment

NCT06836284 | Recruiting

• 1 other identifier: 2024-07214-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Childhood Obesity; Treatment Adherence

Keywords

Mobile Health; Self-Monitoring; Digital Treatment; Anti-Obesity Medication

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of treatment to six months follow-up

Secondary Outcomes (6)

• Proportion achieving less favorable reduction in BMI SDS

  From start of treatment to six months follow-up

• Treatment Adherence

  From start of treatment to six months follow-up

• Side effects

  From start of treatment to six months follow-up

• Professionals perception of the digital tool

  From start of treatment to six months follow-up

• Patients perception of the treatment and digital tool

  From start of treatment to six months follow-up

Study Arms (2)

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.

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.

Drug: Obesity medication with liraglutide or semaglutide

Interventions

Digi-physical treatment tool, Evira DEVICE

A digi-physical treatment tool named Evira will be used to provide behavioral treatment.

Obesity medication liraglutide or semaglutide combined with digi-physical treatment Evira

Obesity medication with liraglutide or semaglutide DRUG

Obesity medication with liraglutide or semaglutide according to the clinic's standard procedure

Control group; Obesity medication liraglutide or semaglutide combined with digi-physical treatment Evira

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients offered liraglutide or semaglutide in accordance with the clinic's routines.
• The family agrees to participate in a clinical study.

You may not qualify if:

• Endocrine disorders other than well-controlled hypothyroidism.
• Severe neuropsychiatric disorders that may affect adherence to the study.
• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Evira AB: collaborator

Study Sites (2)

HKH Crown Princess Victoria's Childrens and youth Hospital Linköping

Linköping, Sweden

RECRUITING

Ystad lasarett, Barn och ungdomsmedicinmottagningen

Ystad, Sweden

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Treatment Adherence and Compliance

Interventions

Liraglutide; semaglutide

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Pernilla Danielsson Liljeqvist, Associate Professor

CONTACT

070-837 7734; pernilla.danielsson.liljeqvist@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 20, 2025
• Study Start: February 13, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

SE (2)