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

NCT04917601 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2025-10-06

No results posted yet for this study

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.

Conditions

  • Childhood Obesity
  • Adolescent Obesity
  • mHealth
  • Personalized Medicine

Interventions

BEHAVIORAL

Evira Care treatment

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.

BEHAVIORAL

Standard Lifestyle Care

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.

Sponsors & Collaborators

Principal Investigators

  • Pernilla Danielsson, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-24
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Italy
  • Norway
  • Poland
  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04917601 on ClinicalTrials.gov