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

ConditionsChildhood Obesity Adolescent Obesity mHealth Personalized Medicine

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age4-17

SponsorKarolinska Institutet

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Evira Care treatment
Behavioral
The intervention aim to examine the effectiveness of using a digital support system (Evira) in treatment of childhood obesity. Through daily weighings at home using a special designed scale, which sends data directly to an application on the parents phone and to a clinic homepage, the child's weight development can be easily monitored. Participants can be randomized to either the intervention group or the control group. The control group will receive local standard treatment.
Standard Lifestyle Care
Behavioral
The control group will receive the local standard care of treatment addressing lifestyles for childhood obesity without any restriction in visits or clinical support. This is the current standard care of treatment for childhood obesity.

Treatment groups

680 Participants

are divided into 2 treatment groups

Group A: Evira Care treatmentExperimental treatment 1 intervention

Group B: Standard Lifestyle CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in degree of obesity

Measured by BMI standard deviation score. Support system users vs. control

Time frame

Baseline, 12-month follow-up

Secondary outcomes

Treatment compliance

Measured by number of physical visits, cancellations, Evira weighings, communication through the system and no-shows

Time frame

Baseline, 12-month follow-up

Psycho-social health measures

Psycho-social health assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. The PROMIS questionnaire is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The output from a PROMIS score is represented as a T-score. Higher scores indicate more of the domain being measured (e.g., more fatigue, more pain).

Time frame

Baseline, 12-month follow-up