RecruitingNot ApplicableNCT04917601

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

A Randomized Controlled Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment (EurEvira)


Sponsor

Karolinska Institutet

Enrollment

680 participants

Start Date

May 24, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 4 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a digital support system (a mobile app used by both families and healthcare providers) can improve the results of childhood obesity treatment. The app allows tracking of lifestyle factors and communication between families and care teams. The study compares families using the app to those receiving standard care. You may be eligible if: - Your child is between 4 and 17 years old - Your child has obesity (iso-BMI 30–40 kg/m²) based on international criteria - Your family can communicate in the language of the country of residence - Parents have a smartphone and email address You may NOT be eligible if: - Your child has morbid obesity (iso-BMI >40) - Your child has an endocrine disorder (other than well-controlled hypothyroidism) - Your child has been treated for depression or other psychiatric disorders in the last 6 months - Your child has hypothalamic or genetic obesity syndrome (e.g., Down syndrome) - Your child has an eating disorder requiring therapy in the past 6 months - Your child is on medications that affect weight Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEvira 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.

BEHAVIORALStandard 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.


Locations(5)

University of Messina

Messina, Italy

University of Campania Luigi Vanvitelli

Naples, Italy

St. Olavs Hospital

Trondheim, Norway

Samodzielny Publiczny Szpital Kliniczny

Szczecin, Poland

Kalmar barnklinik

Kalmar, Sweden

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NCT04917601


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