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

NCT06807489 | Completed

• 1 other identifier: Evira200
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Prevalence of Disordered Eating Behaviors

  The proportion of patients exhibiting documented signs of disordered eating behaviors during or after treatment (e.g., caloric restriction, skipping meals, binge eating).

  From start of treatment to three years follow-up

• Referred patients

  The proportion of patients referred to another clinic for further evaluation of a potential eating disorder.

  From start of treatment to three years follow-up

• Diagnosis of Eating Disorder

  The proportion of patients diagnosed with an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder).

  From start of treatment to three years follow-up

Secondary Outcomes (7)

• Time of Identification of Disordered Eating or Eating Disorder Diagnosis

  From start of treatment to three years follow-up

• Age of Onset of Eating Disorder

  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

Study Arms (1)

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.

Device: Digi-physical treatment tool

Interventions

Digi-physical treatment tool DEVICE

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

Digi-physical treatment group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Evira AB: collaborator

Study Sites (1)

Childrens Hospital Martina

Stockholm, 114 28, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35641569 RESULT

MeSH Terms

Conditions

Pediatric Obesity; Binge-Eating Disorder; Anorexia Nervosa; Bulimia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Signs and Symptoms, Digestive

Study Officials

• Pernilla Danielsson Liljeqvist, Associate Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: January 1, 2025
• Primary Completion: May 8, 2025
• Study Completion: December 31, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)