Childhood ObesityNCT06807489
Disordered Eating Risk in Pediatric Obesity Treatment Using a Digi-Physical Tool
An observational study of Childhood Obesity and Disordered Eating, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The goal of this observational study is to evaluate the risk of developing disordered eating behavior or an eating disorder among children and adolescents with obesity who have used a digi-physical treatment tool with daily measurements conducted at home. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Childhood Obesity, Disordered Eating, Binge Eating Disorder
- What is being tested?
- Digi-physical treatment tool
- Type of treatment
- Medical device
- How many people
- 312 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children aged 4-18 years who begin treatment for childhood obesity at Martina Children's Hospital in Stockholm, Sweden, and are treated with a digi-physical tool as a complement to behavioral therapy will be included. Only children with the possibility of receiving treatment for three years or more will be eligible.
Who may be able to join
- Obesity according to International Obesity Task Force (IOTF)
- Patients aged 6 years and older who have been treated with the digi-physical treatment tool
Who cannot join
- Patients with documented disordered eating behaviors or a diagnosed eating disorder prior to the start of treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Risk of Developing Disordered Eating Behaviors or Eating Disorders in Children and Adolescents With Obesity Using a Digi-Physical Treatment Tool
The goal of this observational study is to evaluate the risk of developing disordered eating behavior or an eating disorder among children and adolescents with obesity who have used a digi-physical treatment tool with daily measurements conducted at home.
The primary outcomes are to:
Read more
- Evaluate the proportion of patients exhibiting documented signs of disordered eating behaviors during or after treatment (e.g., caloric restriction, skipping meals, binge eating).
- Evaluate the proportion of patients diagnosed with an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder) during or after treatment.
Patients at Martina Childrens Hospital, Stockholm, Sweden, who have been treated with the digi-physical treatment tool will be included and their patient records will be reviewed for eating disorder diagnosis or a disturbed eating behavior.
Read the detailed description
Children with chronic illnesses involving dietary restrictions as part of their treatment - such as obesity, diabetes mellitus, and celiac disease- are at an increased risk of developing eating disorders (ED) or disordered eating behaviors (DEB). Children with obesity are more likely to engage in unhealthy weight-control behaviors. Evidence-based, structured treatment programs for obesity do not elevate the risk of ED. On the contrary, such programs often intend to improve overall well-being. Professionally guided obesity treatment for children enhance self-esteem and has been shown to reduce both binge eating and loss of control over eating.
In this study, all participating children undergoing treatment for obesity will use a digi-physical treatment tool as a complement to behavioral treatment. This treatment tool includes daily measurements on a scale that does not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individualized target curve, visualizing the expected weight trajectory. Since weight changes in growing children are complex to interpret, BMI SDS is used as a standard metric. Objective data from the measuring device are automatically transferred to the database. Furthermore, direct communication between the clinic and the family is possible via the clinic interface and the app.
This study builds upon the investigators' previous one-year and three-year studies (ClinicalTrials.gov IDs: NCT04323215 and NCT06434259. The current follow-up study aims to evaluate the risk of developing DEB or an ED over a three-year period following the start of obesity treatment.
Approximately 400 children who have been treated with the digi-physical treatment tool will be included in the evaluation. Diagnoses and symptoms of DEB and ED will be retrieved from patient records.
- Conditions
- Childhood Obesity, Disordered Eating, Binge Eating Disorder, Anorexia Nervosa, Bulimia Nervosa
- Being tested
- Digi-physical treatment tool
- Keywords
- Mobile Health, Support System, Self-Monitoring, Childhood Obesity, Childhood Obesity Treatment, Eating Disorder, Disordered Eating
- Medical subject headings
- Pediatric Obesity, Binge-Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digi-physical treatment toolDevice
A digital treatment tool named Evira will be used to provide the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Digi-physical treatment group | Behavioral treatment combined with a digi-physical treatment tool for self- monitoring of weight and facilitating communication with the clinic. The patients are followed for three years from the start of treatment. Receives: Device: Digi-physical treatment tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Disordered Eating Behaviors
The proportion of patients exhibiting documented signs of disordered eating behaviors during or after treatment (e.g., caloric restriction, skipping meals, binge eating).
Measured: From start of treatment to three years follow-up
Referred patients
The proportion of patients referred to another clinic for further evaluation of a potential eating disorder.
Measured: From start of treatment to three years follow-up
Diagnosis of Eating Disorder
The proportion of patients diagnosed with an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder).
Measured: From start of treatment to three years follow-up
Secondary outcomes (7)
Time of Identification of Disordered Eating or Eating Disorder Diagnosis
Identification of when, during the treatment process, signs of disordered eating or an eating disorder diagnosis are documented
Measured: From start of treatment to three years follow-up
Age of Onset of Eating Disorder
The age at which the first documented signs of disordered eating behaviors or a diagnosed eating disorder occured.
Measured: From start of treatment to three years follow-up
Association with Neurodevelopmental Disorders
Evaluation of the relationship between documented disordered eating behaviors or eating disorders and neurodevelopmental diagnoses, such as ADHD or autism.
Measured: From start of treatment to three years follow-up
Association with Mental Health Issues
Examination of how documented signs of disordered eating behaviors or eating disorders are related to other mental health issues, such as stress, anxiety, or depression.
Measured: From start of treatment to three years follow-up
Change in BMI SDS During Treatment
Change in BMI SDS from the start of treatment as an indicator of treatment efficacy and its potential connection to disordered eating behaviors.
Measured: From start of treatment to the last measurement, up to three-years
Measurement Frequency and Adherence
Analysis of how frequently patients perform the recommended daily measurements and how this correlates with the risk of disordered eating behaviors or other treatment outcomes.
Measured: From start of treatment to three-years follow-up
Association with Curve Patterns
Analysis of the growth or weight curve patterns to identify potential factors indicating disordered eating behaviors or eating disorders.
Measured: From start of treatment to the last measurement, up to three-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Jan 2025
- Primary completion8 May 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Evira AB
- Responsible party
- Principal investigator, Pernilla Danielsson, Karolinska Institutet
- Investigators
- Pernilla Danielsson Liljeqvist, Associate Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807489
- Sponsor's protocol ID
- Evira200
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from Evira AB but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Evira AB.
Publications
Hagman E, Johansson L, Kollin C, Marcus E, Drangel A, Marcus L, Marcus C, Danielsson P. Effect of an interactive mobile health support system and daily weight measurements for pediatric obesity treatment, a 1-year pragmatical clinical trial. Int J Obes (Lond). 2022 Aug;46(8):1527-1533. doi: 10.1038/s41366-022-01146-8. Epub 2022 May 31.
PubMed 35641569
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Risk of Developing Disordered Eating Behaviors or Eating Disorders in Children and Adolescents With Obesity Using a Digi-Physical Treatment Tool
- ClinicalTrials.gov ID
- NCT06807489
- Acronym / sponsor ID
- Evira200
- Conditions
- Childhood Obesity, Disordered Eating, Binge Eating Disorder, Anorexia Nervosa, Bulimia Nervosa
- Keywords
- Mobile Health, Support System, Self-Monitoring, Childhood Obesity, Childhood Obesity Treatment, Eating Disorder, Disordered Eating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Evira AB
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 4 Feb 2025 (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.
The goal of this observational study is to evaluate the risk of developing disordered eating behavior or an eating disorder among children and adolescents with obesity who have used a digi-physical treatment tool with daily measurements conducted at home.
The primary outcomes are to:
- Evaluate the proportion of patients exhibiting documented signs of disordered eating behaviors during or after treatment (e.g., caloric restriction, skipping meals, binge eating).
- Evaluate the proportion of patients diagnosed with an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder) during or after treatment.
Patients at Martina Childrens Hospital, Stockholm, Sweden, who have been treated with the digi-physical treatment tool will be included and their patient records will be reviewed for eating disorder diagnosis or a disturbed eating behavior.
Detailed description
Children with chronic illnesses involving dietary restrictions as part of their treatment - such as obesity, diabetes mellitus, and celiac disease- are at an increased risk of developing eating disorders (ED) or disordered eating behaviors (DEB). Children with obesity are more likely to engage in unhealthy weight-control behaviors. Evidence-based, structured treatment programs for obesity do not elevate the risk of ED. On the contrary, such programs often intend to improve overall well-being. Professionally guided obesity treatment for children enhance self-esteem and has been shown to reduce both binge eating and loss of control over eating.
In this study, all participating children undergoing treatment for obesity will use a digi-physical treatment tool as a complement to behavioral treatment. This treatment tool includes daily measurements on a scale that does not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individualized target curve, visualizing the expected weight trajectory. Since weight changes in growing children are complex to interpret, BMI SDS is used as a standard metric. Objective data from the measuring device are automatically transferred to the database. Furthermore, direct communication between the clinic and the family is possible via the clinic interface and the app.
This study builds upon the investigators' previous one-year and three-year studies (ClinicalTrials.gov IDs: NCT04323215 and NCT06434259. The current follow-up study aims to evaluate the risk of developing DEB or an ED over a three-year period following the start of obesity treatment.
Approximately 400 children who have been treated with the digi-physical treatment tool will be included in the evaluation. Diagnoses and symptoms of DEB and ED will be retrieved from patient records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digi-physical treatment group | – | Device: Digi-physical treatment toolBehavioral treatment combined with a digi-physical treatment tool for self- monitoring of weight and facilitating communication with the clinic. The patients are followed for three years from the start of treatment. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children aged 4-18 years who begin treatment for childhood obesity at Martina Children's Hospital in Stockholm, Sweden, and are treated with a digi-physical tool as a complement to behavioral therapy will be included. Only children with the possibility of receiving treatment for three years or more will be eligible.
Key inclusion criteria (2 listed)
- Obesity according to International Obesity Task Force (IOTF)
- Patients aged 6 years and older who have been treated with the digi-physical treatment tool
Key exclusion criteria (1 listed)
- Patients with documented disordered eating behaviors or a diagnosed eating disorder prior to the start of treatment.
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 |
|---|---|---|
| Digi-physical treatment toolA digital treatment tool named Evira will be used to provide the treatment. | Device | Digi-physical treatment group |
Primary outcome
Prevalence of Disordered Eating Behaviors
Time frame: From start of treatment to three years follow-up
The proportion of patients exhibiting documented signs of disordered eating behaviors during or after treatment (e.g., caloric restriction, skipping meals, binge eating).
Referred patients
Time frame: From start of treatment to three years follow-up
The proportion of patients referred to another clinic for further evaluation of a potential eating disorder.
Diagnosis of Eating Disorder
Time frame: From start of treatment to three years follow-up
The proportion of patients diagnosed with an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder).
7 secondary outcomes
Time of Identification of Disordered Eating or Eating Disorder Diagnosis
Time frame: From start of treatment to three years follow-up
Age of Onset of Eating Disorder
Time frame: From start of treatment to three years follow-up
Association with Neurodevelopmental Disorders
Time frame: From start of treatment to three years follow-up
Association with Mental Health Issues
Time frame: From start of treatment to three years follow-up
Change in BMI SDS During Treatment
Time frame: From start of treatment to the last measurement, up to three-years
Measurement Frequency and Adherence
Time frame: From start of treatment to three-years follow-up
Association with Curve Patterns
Time frame: From start of treatment to the last measurement, up to three-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Results publication: PubMed 35641569Hagman E, Johansson L, Kollin C, Marcus E, Drangel A, Marcus L, Marcus C, Danielsson P. Effect of an interactive mobile health support system and daily weight measurements for pediatric obesity treatment, a 1-year pragmatical clinical trial. Int J Obes (Lond). 2022 Aug;46(8):1527-1533. doi: 10.1038/s41366-022-01146-8. Epub 2022 May 31.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from Evira AB but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Evira AB.
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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. This study is not recruiting at the moment.
Pernilla Danielsson Liljeqvist, Associate Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity and Disordered Eating, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Disordered Eating Behaviors (time frame: From start of treatment to three years follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06807489, which also lists 1 linked publication.
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 30 Apr 2026.