NCT06434259

Evaluation of Long-term Digital Childhood Obesity Treatment

Long-term Results of an Interactive Mobile Health Support System and Daily Home-weighing as an add-on to Pediatric Obesity Lifestyle Treatment: A 3-year Pragmatic Clinical Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 428 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Childhood Obesity
• Treatment Adherence

Interventions

Type	Name	Description
DEVICE	Digi-physical support system	A support system named Evira will be used to provide behavioral treatment.

Timeline

• Start date: 2018-09-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2024-05-30
• Last updated: 2024-05-31

Locations

1 site across 1 country: Sweden