Actively Recruiting
A Randomized Controlled Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment (EurEvira)
Led by Karolinska Institutet · Updated on 2025-10-06
680
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
L
Lund University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Childhood obesity is a growing global health concern linked to serious health problems such as type 2 diabetes, high blood pressure, certain cancers, and mental health challenges. Researchers are evaluating a digital support system called Evira to help improve treatment outcomes for children with obesity. This randomized controlled study aims to assess the effects of adding Evira to the usual lifestyle treatment for childhood obesity in children aged 4 to 17 years. The study compares two groups: one receiving Evira Care combined with standard lifestyle treatment, and the other receiving standard lifestyle care alone. Evira Care involves daily weight monitoring at home using a special scale connected to a mobile app and website, allowing parents and clinicians to track weight changes and communicate easily. The intervention group will receive guidance on how to use the system and make feasible lifestyle changes, with weight targets set for the first three months. The control group continues with standard care without restrictions on visits or clinical support. Participants will be involved for 12 months, undergoing clinical exams including puberty assessment, cardio-respiratory, thyroid, skin, and abdominal checks, along with measurements of weight, height, and blood pressure. Blood tests may be done as needed. All participants will complete questionnaires about quality of life, eating disorders, and treatment satisfaction. Researchers will monitor weight change as the primary outcome, along with treatment compliance and psychosocial health measures, while collecting information on any side effects.
CONDITIONS
Brief Title
A Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 4.0 and less than 17.0 years at inclusion
- Obesity defined by iso-BMI between 30 and 40 kg/m2
- Willingness to participate in an obesity treatment clinical trial
- Family able to communicate in the country’s language, including reading and writing messages in the mobile app
- Parents have a smartphone and an email address
You will not qualify if you...
- Morbid obesity defined as iso-BMI greater than 40 kg/m2
- Endocrine disorders except well-controlled hypothyroidism
- Metabolic disorders affecting weight control
- Treatment for depression or other psychiatric disorders within 6 months before inclusion
- Use of medications that affect weight control
- Hypothalamic or monogenic obesity, including syndromes and Down syndrome
- Severe neuropsychiatric disorders affecting study compliance
- Eating disorders requiring therapy within 6 months before inclusion or observed at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either Evira Care combined with Standard Lifestyle Care or Standard Lifestyle Care alone to address childhood obesity through lifestyle changes. The intervention group will learn to use a digital support system including daily weight monitoring and communication via an app.
Visits as per local standard care schedule, limited to a maximum of one visit every third month for the intervention group after the first month
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
Research Team
P
Pernilla Danielsson Liljeqvist, Associate Professor
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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