A Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment (EurEvira)
Childhood Obesity, Adolescent Obesity, mHealth
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Obesity treatment, Digital support system
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
- 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 BMI>35kg/m2 independently of age
- Weight loss more than 0,1 BMI SDS during the last three months
- 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.
Sites / Locations
- Hôpital Robert Debré
- St. Olavs HospitalRecruiting
- Kalmar barnklinikRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Evira Care treatment
Standard Lifestyle Care
The intervention arm will receive Evira Care in combination with Standard Lifestyle Care. If the standard treatment, after the first month of treatment, contains more frequent visits than every third month, the number of standard visits shall be reduced to a maximum of one visit every third month. During the first 2-4 weeks, participants will receive information about the system and how to utilize the daily weighings and communication system. The families will be informed about possible lifestyle changes that may be effective and that they are supposed to do lifestyle changes primarily regarding energy intake that they do consider feasible in their specific living situations. Clinical investigations will be completed and includes physical and abdominal examinations, weight, height, and blood pressure. All participants will also be asked to answer questionnaires including quality of life, eating disorders, and treatment satisfaction.
The control group will receive the standard care of treatment for childhood obesity, which addresses lifestyles without any restriction in visits or clinical support. Clinical investigations will be completed and includes physical and abdominal examinations, weight, height, and blood pressure. All participants will also be asked to answer questionnaires including quality of life, eating disorders, and treatment satisfaction.