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

Active, not recruiting

• Conditions: Childhood Obesity; Disordered Eating; Binge Eating Disorder; Anorexia Nervosa; Bulimia Nervosa

• Registration Number: NCT06807489
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Disordered Eating Behaviors	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	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	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).

Secondary Outcome Measures

Name	Time	Method
Time of Identification of Disordered Eating or Eating Disorder Diagnosis	From start of treatment to three years follow-up	Identification of when, during the treatment process, signs of disordered eating or an eating disorder diagnosis are documented
Age of Onset of Eating Disorder	From start of treatment to three years follow-up	The age at which the first documented signs of disordered eating behaviors or a diagnosed eating disorder occured.
Association with Neurodevelopmental Disorders	From start of treatment to three years follow-up	Evaluation of the relationship between documented disordered eating behaviors or eating disorders and neurodevelopmental diagnoses, such as ADHD or autism.
Association with Mental Health Issues	From start of treatment to three years follow-up	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.
Change in BMI SDS During Treatment	From start of treatment to the last measurement, up to three-years	Change in BMI SDS from the start of treatment as an indicator of treatment efficacy and its potential connection to disordered eating behaviors.
Measurement Frequency and Adherence	From start of treatment to three-years follow-up	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.
Association with Curve Patterns	From start of treatment to the last measurement, up to three-years	Analysis of the growth or weight curve patterns to identify potential factors indicating disordered eating behaviors or eating disorders.

Trial Locations

Locations (1)

Childrens Hospital Martina; 🇸🇪 Stockholm, Sweden