NCT04917601

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
4 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
May 2022Dec 2027

First Submitted

Initial submission to the registry

June 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

May 24, 2022

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

5.5 years

First QC Date

June 2, 2021

Last Update Submit

September 30, 2025

Conditions

Childhood ObesityAdolescent ObesitymHealthPersonalized Medicine

Keywords

Obesity treatmentDigital support system

Outcome Measures

Primary Outcomes (1)

  • Change in degree of obesity

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

    Baseline, 12-month follow-up

Secondary Outcomes (2)

  • Treatment compliance

    Baseline, 12-month follow-up

  • Psycho-social health measures

    Baseline, 12-month follow-up

Study Arms (2)

Evira Care treatment

EXPERIMENTAL

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.

Behavioral: Evira Care treatment

Standard Lifestyle Care

ACTIVE COMPARATOR

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.

Behavioral: Standard Lifestyle Care

Interventions

Evira Care treatmentBEHAVIORAL

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.

Evira Care treatment
Standard Lifestyle CareBEHAVIORAL

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.

Standard Lifestyle Care

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Messina

Messina, 98125, Italy

NOT YET RECRUITING

University of Campania Luigi Vanvitelli

Naples, 80138, Italy

RECRUITING

St. Olavs Hospital

Trondheim, 7030, Norway

ACTIVE NOT RECRUITING

Samodzielny Publiczny Szpital Kliniczny

Szczecin, 71-252, Poland

RECRUITING

Kalmar barnklinik

Kalmar, 391 85, Sweden

COMPLETED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pernilla Danielsson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pernilla Danielsson Liljeqvist, Associate Professor

CONTACT

+46 708 377734pernilla.danielsson-liljeqvist@regionstockholm.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Children aged 4-17 years old with obesity will be randomized to either the intervention group or the control group. The intervention group will through daily weighings at home be able to follow treatment closely in an application on the parents phone. Through a communication function in the application, families will be able to communicate in a fast and easy way with healthcare professionals at the clinic. The control group will receive Standard Lifestyle Care following local routines. The study duration is 12 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric nurse, Associate Professor

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 8, 2021

Study Start

May 24, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Anonymized data for the main outcome will be available upon date of scientific publications. To preserve individual case and anonymity, more detailed data and additional variables will be available upon request.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Data will become available upon date of scientific publications or on requests.

Locations

NO(1)PL(1)IT(2)SE(1)