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Search / Trial NCT04917601

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

Launched by KAROLINSKA INSTITUTET · Jun 2, 2021

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Obesity Treatment Digital Support System

ClinConnect Summary

This clinical trial is studying a new digital support system called Evira, designed to help manage childhood obesity. Evira allows children and their families to weigh themselves at home using a special scale and communicate easily with their healthcare team through a mobile app. The goal of the study is to see how adding this digital tool to the usual lifestyle treatments for obesity can improve weight management in children and adolescents.

To participate, children must be between 4 and 17 years old and have a body mass index (BMI) that shows they are obese (which means their weight is higher than what is considered healthy for their height). Families need to be able to use the app and have a smartphone and an email address. However, children with certain medical conditions, severe obesity, or eating disorders may not be eligible for the study. Participants can expect to receive support and guidance through the app while working towards healthier weight goals alongside their healthcare providers. This trial is currently looking for volunteers to take part.

Gender

ALL

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 before inclusion or observed at the inclusion screening.

About Karolinska Institutet

Karolinska Institutet is a renowned medical university located in Sweden, recognized for its commitment to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the institution focuses on translating scientific discoveries into effective treatments and therapies, emphasizing patient-centered approaches. With a strong emphasis on collaboration and interdisciplinary research, Karolinska Institutet plays a pivotal role in addressing global health challenges and improving patient outcomes, leveraging its extensive network of experts and state-of-the-art facilities to drive clinical advancements.

Locations

Paris, , France

Trondheim, , Norway

Messina, , Italy

Oslo, , Norway

Naples, , Italy

Kalmar, , Sweden

Kalmar, , Sweden

Patients applied

0 patients applied

Trial Officials

Pernilla Danielsson, PhD

Principal Investigator

Karolinska Institutet

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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