Status:
RECRUITING
A Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Lund University
Evira AB
Conditions:
Childhood Obesity
Adolescent Obesity
Eligibility:
All Genders
4-17 years
Phase:
NA
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, e...
Detailed Description
Obesity in childhood is a global public health problem which continues to increase. It is associated with type 2 diabetes, high blood pressure, certain types of cancer, decreased psychosocial health a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
680 Patients enrolled
Trial Details
Trial ID
NCT04917601
Start Date
May 24 2022
End Date
December 1 2027
Last Update
October 6 2025
Active Locations (5)
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1
University of Messina
Messina, Italy, 98125
2
University of Campania Luigi Vanvitelli
Naples, Italy, 80138
3
St. Olavs Hospital
Trondheim, Norway, 7030
4
Samodzielny Publiczny Szpital Kliniczny
Szczecin, Poland, 71-252