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Clinical Trials in Sweden / NCT04917601
Recruiting Not applicable

A Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment

NCT04917601 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska Institutet
Phase
Not applicable
Started
2022-05-24
Last updated
2025-10-06

Condition(s) studied

Childhood ObesityAdolescent ObesitymHealthPersonalized Medicine

Investigational drug(s) / intervention(s)

Evira Care treatmentStandard Lifestyle Care

Evira Care treatment: The intervention aim to examine the effectiveness of using a digital support system (Evira) in treatment of childhood obesity. Through daily weighings at home using a special designed scale, which sends data directly to an application on the parents phone and to a clinic homepage, the child's weight development can be easily monitored. Participants can be randomized to either the intervention group or the control group. The control group will receive local standard treatment.

Standard Lifestyle Care: The control group will receive the local standard care of treatment addressing lifestyles for childhood obesity without any restriction in visits or clinical support. This is the current standard care of treatment for childhood obesity.

Study summary

Evira is a digital support system newly developed for treatment of childhood obesity. Through daily weighings at home using a special scale together with a message function in the Evira application, enabling fast and easy communication with the clinic, parents and the clinicians can easily follow the child's weight development. The purpose of this randomized controlled study is to evaluate the effect of adding Evira to the already locally used life-style treatment of childhood obesity.

Eligibility

Sex
ALL
Min age
4 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Age \>4.0 and \<17.0 years of age at inclusion * Obesity defined based on the International Obesity Task Force criteria iso-BMI 30 - 40 kg/m2 * Willingness to participate in an obesity treatment clinical trial * Family ability to communicate in the language of the country of residence e.g. write and read messages in the mobile application * Parents having a smart phone and an email address Exclusion Criteria: * Morbid obesity defined as iso-BMI\>40kg/m2 independently of age * Endocrine disorders other than well controlled hypothyroidism * Metabolic disorders of importance for weight control - to be discussed * Treatment for depression and other psychiatric disorders during the last 6 months before inclusion * Pharmacological treatment of importance for weight control * Hypothalamic or monogenic obesity, e.g. syndromes and Mb Down * Severe neuropsychiatric disorders that could affect study compliance * Eating disorders requiring therapy during the last six months before inclusion or observed at the inclusion screening.

Primary outcome measure(s)

  • Change in degree of obesity — Baseline, 12-month follow-up
    Measured by BMI standard deviation score. Support system users vs. control

Trial sites (5)

FacilityCityRegionStatus
University of Messina Messina Italy Not Yet Recruiting
University of Campania Luigi Vanvitelli Naples Italy Recruiting
St. Olavs Hospital Trondheim Norway Active Not Recruiting
Samodzielny Publiczny Szpital Kliniczny Szczecin Poland Recruiting
Kalmar barnklinik Kalmar Sweden Completed

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Other trials for the same condition

The Evira Study: Additional Support During Obesity Treatment Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04917601 on ClinicalTrials.gov ↗ ← All trials in Sweden