Childhood ObesityEurEviraNCT04917601
A Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment
A study testing Evira Care treatment and Standard Lifestyle Care in people with Childhood Obesity and Adolescent Obesity, run by Karolinska Institutet at 5 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Childhood Obesity, Adolescent Obesity, mHealth
- What is being tested?
- Evira Care treatment and Standard Lifestyle Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 24 May 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Parents having a smart phone and an email address
Who cannot join
- 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
- 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.
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Pernilla Danielsson Liljeqvist, Associate Professor contact
5 sites in 4 countries
Italy2 sites, 2 recruiting
- Not yet recruiting
University of Messina
Messina, 98125
Domenico Corica, MD, PhD, domenico.corica@unime.it
- Recruiting
University of Campania Luigi Vanvitelli
Naples, 80138
Giuseppina Rosaria Umano, Dr., giuseppinarosaria.umano@unicampania.it
Poland1 site, 1 recruiting
- Recruiting
Samodzielny Publiczny Szpital Kliniczny
Szczecin, 71-252
Elzbieta Petriczko, Dr., +48602731533, elzbieta.petriczko@pum.edu.pl
About this study
Official title: A Randomized Controlled Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment (EurEvira)
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.
Read the detailed description
Obesity in childhood is a global public health problem which continues to increase. It is associated with type 2 diabetes, high blood pressure, certain types of cancer, decreased psychosocial health and early mortality, among many other short- and long-term consequences. It is estimated that families of children with obesity need at least 26 hours of contact with the health care per year to make it possible for the children to reach a clinically relevant reduction in degree of obesity. Such visit frequency is difficult to carry out due to its cost for society and places great demands on families.
A digital support system named Evira has newly been developed and is based on four cornerstones; a) daily self-monitoring of weight, b) a mobile app used by parents to easily follow weight development, c) a website on which clinicians view the same data as parents do and d) communication between clinicians and parents by text messages through the website and the mobile app. Hence, Evira enables close follow-up of treatment results and continuous communication between the healthcare and the families.
The overall aim is to evaluate the effects of adding Evira, a digital support system for childhood obesity treatment and accompanying treatment manual, to the already locally used life-style treatment.
Boys and girls aged 4-17 years old with obesity will be asked for participation. All patient who fulfills the inclusion criteria and have signed the informed consent form will be included and randomized into the study. Randomization means that the patient can either be randomized to intervention (Evira Care) or control (Standard Lifestyle Care) group.
The study duration is 12 months. The Intervention group will receive Evira support (Evira Care) in combination with local standard treatment (Standard Lifestyle Care). During the first 2-4 weeks, they 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. Furthermore, they will be informed that they are supposed to do lifestyle changes primarily regarding energy intake that they do consider feasible in their specific living situations. Within four weeks after randomization, the families will get one or two scales, depending on the family situation. The parent's will also have the mobile app installed in their smart phones and, depending on the age of the child, in the child's phone as well. The individual weight loss target curve for the first three months of treatment will be installed in the database and presented in the application. The control group will receive Standard Lifestyle Care without any restriction in visits or clinical support.
The following clinical investigations will be completed in both groups: 1) Physical examination including puberty, cardio-respiratory, thyroid status, skin (e.g. acanthosis nigricans) and abdominal examinations, and 2) Weight, height, and blood pressure. Blood sampling in accordance with local routine can be reported at any time-point.
In addition to the clinical investigation, all participants will be asked to answer questionnaires including quality of life, eating disorders, and treatment satisfaction. Background information and negative side effects will be reported in the electronic case report form (e-crf).
- Conditions
- Childhood Obesity, Adolescent Obesity, mHealth, Personalized Medicine
- Being tested
- Evira Care treatment, Standard Lifestyle Care
- Keywords
- Obesity treatment, Digital support system
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evira Care treatmentBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Lifestyle Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in degree of obesity
Measured by BMI standard deviation score. Support system users vs. control
Measured: Baseline, 12-month follow-up
Secondary outcomes (2)
Treatment compliance
Measured by number of physical visits, cancellations, Evira weighings, communication through the system and no-shows
Measured: 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).
Measured: Baseline, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start24 May 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Evira AB
- Responsible party
- Principal investigator, Pernilla Danielsson, Karolinska Institutet
- Investigators
- Pernilla Danielsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917601
- Sponsor's protocol ID
- 2019-05513
- Other IDs
- 2019-05513, 2019
- Acronym
- EurEvira
- Status last verified
- Sep 2025
- First submitted
- 2 Jun 2021
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment (EurEvira)
- ClinicalTrials.gov ID
- NCT04917601
- Acronym / sponsor ID
- EurEvira / 2019-05513
- Conditions
- Childhood Obesity, Adolescent Obesity, mHealth, Personalized Medicine
- Keywords
- Obesity treatment, Digital support system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Lund University, Evira AB
- Study start
- 24 May 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity in childhood is a global public health problem which continues to increase. It is associated with type 2 diabetes, high blood pressure, certain types of cancer, decreased psychosocial health and early mortality, among many other short- and long-term consequences. It is estimated that families of children with obesity need at least 26 hours of contact with the health care per year to make it possible for the children to reach a clinically relevant reduction in degree of obesity. Such visit frequency is difficult to carry out due to its cost for society and places great demands on families.
A digital support system named Evira has newly been developed and is based on four cornerstones; a) daily self-monitoring of weight, b) a mobile app used by parents to easily follow weight development, c) a website on which clinicians view the same data as parents do and d) communication between clinicians and parents by text messages through the website and the mobile app. Hence, Evira enables close follow-up of treatment results and continuous communication between the healthcare and the families.
The overall aim is to evaluate the effects of adding Evira, a digital support system for childhood obesity treatment and accompanying treatment manual, to the already locally used life-style treatment.
Boys and girls aged 4-17 years old with obesity will be asked for participation. All patient who fulfills the inclusion criteria and have signed the informed consent form will be included and randomized into the study. Randomization means that the patient can either be randomized to intervention (Evira Care) or control (Standard Lifestyle Care) group.
The study duration is 12 months. The Intervention group will receive Evira support (Evira Care) in combination with local standard treatment (Standard Lifestyle Care). During the first 2-4 weeks, they 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. Furthermore, they will be informed that they are supposed to do lifestyle changes primarily regarding energy intake that they do consider feasible in their specific living situations. Within four weeks after randomization, the families will get one or two scales, depending on the family situation. The parent's will also have the mobile app installed in their smart phones and, depending on the age of the child, in the child's phone as well. The individual weight loss target curve for the first three months of treatment will be installed in the database and presented in the application. The control group will receive Standard Lifestyle Care without any restriction in visits or clinical support.
The following clinical investigations will be completed in both groups: 1) Physical examination including puberty, cardio-respiratory, thyroid status, skin (e.g. acanthosis nigricans) and abdominal examinations, and 2) Weight, height, and blood pressure. Blood sampling in accordance with local routine can be reported at any time-point.
In addition to the clinical investigation, all participants will be asked to answer questionnaires including quality of life, eating disorders, and treatment satisfaction. Background information and negative side effects will be reported in the electronic case report form (e-crf).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Evira Care treatment | Experimental | Behavioral: Evira Care treatmentThe 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. |
| Standard Lifestyle Care | Active comparator | Behavioral: Standard Lifestyle CareThe 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. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
- Parents having a smart phone and an email address
Key exclusion criteria (8 listed)
- 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
- Pharmacological treatment of importance for weight control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evira Care treatmentThe 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. | Behavioural | Evira Care treatment |
| Standard Lifestyle CareThe 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. | Behavioural | Standard Lifestyle Care |
Primary outcome
Change in degree of obesity
Time frame: Baseline, 12-month follow-up
Measured by BMI standard deviation score. Support system users vs. control
2 secondary outcomes
Treatment compliance
Time frame: Baseline, 12-month follow-up
Psycho-social health measures
Time frame: Baseline, 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pernilla Danielsson Liljeqvist, Associate Professor contact
Pernilla Danielsson, PhD principal investigator
Karolinska Institutet
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evira Care treatment and Standard Lifestyle Care in people with Childhood Obesity and Adolescent Obesity, run by Karolinska Institutet at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Norway, Poland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pernilla Danielsson Liljeqvist, Associate Professor (+46 708 377734, pernilla.danielsson-liljeqvist@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in degree of obesity (time frame: Baseline, 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.