Evaluation of Long-term Digital Childhood Obesity Treatment

NCT06434259 | Completed

• 1 other identifier: Evira100
• Study Type: observational
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the number of missed visits.

Conditions

Childhood Obesity; Treatment Adherence

Keywords

Mobile Health; Support System; Behavioral Treatment; Self-Monitoring

Outcome Measures

Primary Outcomes (1)

• Change in degree of obesity

  Measured by BMI standard deviation score. Digi-physical group vs. control group

  From start of treatment to three years follow-up

Secondary Outcomes (5)

• The use of the support system - weighings

  From start of treatment to three years follow-up

• The use of the support system - text messages

  From start of treatment to three years follow-up

• Number of physical visits

  From start of treatment to three years follow-up

• Number of cancelation of physical visits

  From start of treatment to three years follow-up

• Number of patients not showing up to physical visit

  From start of treatment to three years follow-up

Study Arms (2)

Digi-physical treatment group

Usual care (behavioral treatment) plus the support system for self- monitoring of weight and communication with the clinic during three years of treatment.

Device: Digi-physical support system

Control group

Children treated with usual care according to regular treatment routines registered in the Swedish childhood obesity treatment register, BORIS

Interventions

Digi-physical support system DEVICE

A support system named Evira will be used to provide behavioral treatment.

Digi-physical treatment group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children who start treatment for childhood obesity at Martina children Hospital will use a digital support system as a complement to behavioral treatment. 107 children in the digit-physical group and 321 children in the control group, aged 4-17.9 years, will be included.

You may qualify if:

• Obesity according to International Obesity Task Force (IOTF)

You may not qualify if:

• None

Sponsors & Collaborators

• Karolinska Institutet: lead

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; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

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

Study Officials

• Pernilla Danielsson Liljeqvist, PhD

  Karolinska Institutet, CLINTEC, Division of pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: September 1, 2018
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

SE (1)