NCT04917601 A Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment
| NCT ID | NCT04917601 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Childhood Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 680 participants |
| Start Date | 2022-05-24 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 680 participants in total. It began in 2022-05-24 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 before inclusion or observed at the inclusion screening.
Contact & Investigator
Pernilla Danielsson Liljeqvist, Associate Professor
✉ pernilla.danielsson-liljeqvist@regionstockholm.se📞 +46 708 377734
Pernilla Danielsson, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT04917601 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 17 Years, studying Childhood Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04917601 currently recruiting?
Yes, NCT04917601 is actively recruiting participants. Contact the research team at pernilla.danielsson-liljeqvist@regionstockholm.se for enrollment information.
Where is the NCT04917601 trial being conducted?
This trial is being conducted at Messina, Italy, Naples, Italy, Trondheim, Norway, Szczecin, Poland and 1 additional location.
Who is sponsoring the NCT04917601 clinical trial?
NCT04917601 is sponsored by Karolinska Institutet. The principal investigator is Pernilla Danielsson, PhD at Karolinska Institutet. The trial plans to enroll 680 participants.
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