Disordered Eating Risk in Pediatric Obesity Treatment Using a Digi-Physical Tool

NCT ID: NCT06807489

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-12-31

Brief 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.

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.

Conditions

Childhood Obesity; Disordered Eating; Binge Eating Disorder; Anorexia Nervosa; Bulimia Nervosa

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Digi-physical treatment tool

Intervention Type: DEVICE

A digital treatment tool named Evira will be used to provide the treatment.

Interventions

Digi-physical treatment tool

A digital treatment tool named Evira will be used to provide the treatment.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Obesity according to International Obesity Task Force (IOTF)
• Patients aged 6 years and older who have been treated with the digi-physical treatment tool

Exclusion Criteria

• Patients with documented disordered eating behaviors or a diagnosed eating disorder prior to the start of treatment.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evira AB

INDUSTRY

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Pernilla Danielsson

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pernilla Danielsson Liljeqvist, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Childrens Hospital Martina

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 35641569 (View on PubMed)

Other Identifiers

Evira200

Identifier Type: -

Identifier Source: org_study_id