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Recruiting NCT04917601

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

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Trial Parameters

Condition Childhood Obesity
Sponsor Karolinska Institutet
Study Type INTERVENTIONAL
Phase N/A
Enrollment 680
Sex ALL
Min Age 4 Years
Max Age 17 Years
Start Date 2022-05-24
Completion 2027-12
Interventions
Evira Care treatmentStandard Lifestyle Care

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Brief 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 Criteria

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 b

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