Actively Recruiting

Phase Not Applicable
Age: 4Years - 17Years
All Genders
NCT04917601

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

Led by Karolinska Institutet · Updated on 2025-10-06

680

Participants Needed

5

Research Sites

288 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

L

Lund University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 4Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 4 and under 17 years at inclusion
  • Obesity defined by International Obesity Task Force criteria with iso-BMI between 30 and 40 kg/m2
  • Willingness to participate in an obesity treatment clinical trial
  • Family able to communicate in the country language, including reading and writing messages in the mobile app
  • Parents have a smartphone and an email address
Not Eligible

You will not qualify if you...

  • Morbid obesity defined as iso-BMI over 40 kg/m2 regardless of age
  • Endocrine disorders except well-controlled hypothyroidism
  • Metabolic disorders affecting weight control (to be discussed)
  • Treatment for depression or other psychiatric disorders in the last 6 months before inclusion
  • Pharmacological treatments affecting weight control
  • Hypothalamic or monogenic obesity, including syndromes and Down syndrome
  • Severe neuropsychiatric disorders affecting study compliance
  • Eating disorders requiring therapy in the last 6 months or observed at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

University of Messina

Messina, Italy, 98125

Not Yet Recruiting

2

University of Campania Luigi Vanvitelli

Naples, Italy, 80138

Actively Recruiting

3

St. Olavs Hospital

Trondheim, Norway, 7030

Active, Not Recruiting

4

Samodzielny Publiczny Szpital Kliniczny

Szczecin, Poland, 71-252

Actively Recruiting

5

Kalmar barnklinik

Kalmar, Sweden, 391 85

Completed

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Research Team

P

Pernilla Danielsson Liljeqvist, Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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