Evaluation of the Risk of Developing Disordered Eating Behaviors or Eating Disorders in Children and Adolescents With Obesity Using a Digi-Physical Treatment Tool
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 312
- Locations
- 1
- Primary Endpoint
- Referred patients
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Digi-physical treatment tool (Device)
Outcomes
Primary Outcomes
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).
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).
Secondary Outcomes
- Age of Onset of Eating Disorder(From start of treatment to three years follow-up)
- Time of Identification of Disordered Eating or Eating Disorder Diagnosis(From start of treatment to three years follow-up)
- Association with Neurodevelopmental Disorders(From start of treatment to three years follow-up)
- Association with Mental Health Issues(From start of treatment to three years follow-up)
- Change in BMI SDS During Treatment(From start of treatment to the last measurement, up to three-years)
- Measurement Frequency and Adherence(From start of treatment to three-years follow-up)
- Association with Curve Patterns(From start of treatment to the last measurement, up to three-years)
Investigators
Pernilla Danielsson
Principal investigator
Karolinska Institutet