Clinical trial NCT06807489: Disordered Eating Risk in Pediatric Obesity Treatment Using a Digi-Physical Tool
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Evira AB
First posted: 2025-02-04
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Primary outcomes:
measure: Prevalence of Disordered Eating Behaviors
timeFrame: From start of treatment to three years follow-up
measure: Referred patients
timeFrame: From start of treatment to three years follow-up
measure: Diagnosis of Eating Disorder
timeFrame: From start of treatment to three years follow-up
Secondary outcomes:
measure: Time of Identification of Disordered Eating or Eating Disorder Diagnosis
timeFrame: From start of treatment to three years follow-up
measure: Age of Onset of Eating Disorder
timeFrame: From start of treatment to three years follow-up
measure: Association with Neurodevelopmental Disorders
timeFrame: From start of treatment to three years follow-up
measure: Association with Mental Health Issues
timeFrame: From start of treatment to three years follow-up
measure: Change in BMI SDS During Treatment
timeFrame: From start of treatment to the last measurement, up to three-years
measure: Measurement Frequency and Adherence
timeFrame: From start of treatment to three-years follow-up
measure: Association with Curve Patterns
timeFrame: From start of treatment to the last measurement, up to three-years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Childrens Hospital Martina
Study officials:
affiliation: Karolinska Institutet
name: Pernilla Danielsson Liljeqvist, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.