Evaluation of Long-term Digital Childhood Obesity Treatment

Karolinska Institute

Status: Completed

Conditions: Childhood Obesity; Treatment Adherence

Treatments: Device: Digi-physical support system

Study type: Observational

Funder types: Other

Identifiers

NCT06434259

Evira100

Details and patient eligibility

About

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.

Full description

Childhood obesity treatment is time consuming for both the health care system, and for the involved families. There is an association between the intensity and the outcome of treatment.

In this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. The digital support system includes daily weighing on scales that do 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 individual target curve visualizing the expected weight journey. Weight in growing children is complex to interpret why BMI SDS is used. Objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app.

The present study is a continuation of the investigators previous one-year study, Clinicaltrials.gov ID: NCT04323215. In this follow-up study, the investigators aim to assess the treatment outcomes over a three-year period.

The evaluation will be carried out on 107 children who underwent digi-physical treatment for three years. The results will be compared with a matched control group (n=321) from the Swedish childhood obesity treatment register, BORIS.

Enrollment: 428 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obesity according to International Obesity Task Force (IOTF)

Exclusion criteria

• None

Trial design

428 participants in 2 patient groups

Digi-physical treatment group

Description:

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

Treatment:

Device: Digi-physical support system

Control group

Description:

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