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Completed

NCT Number: NCT06807489

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

* 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.

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Key information

Conditions

Childhood Obesity Anorexia Nervosa Binge Eating Disorder Binge-Eating Disorder Body Weight Bulimia Nervosa Disordered Eating Feeding and Eating Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Hospital Martina

Stockholm, 114 28, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digi-physical treatment tool

Device

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

Primary outcomes

  1. 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).

  2. 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.

  3. 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).

Secondary outcomes

  1. Time of Identification of Disordered Eating or Eating Disorder Diagnosis

    Time frame: 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

  2. Age of Onset of Eating Disorder

    Time frame: 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.

  3. Association with Neurodevelopmental Disorders

    Time frame: 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.

  4. Association with Mental Health Issues

    Time frame: 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.

  5. Change in BMI SDS During Treatment

    Time frame: 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.

  6. Measurement Frequency and Adherence

    Time frame: 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.

  7. Association with Curve Patterns

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Evira AB

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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