Evaluation of Long-term Digital Childhood Obesity Treatment

Completed

• Conditions: Childhood Obesity; Treatment Adherence
• Interventions: Device: Digi-physical support system

• Registration Number: NCT06434259
• Lead Sponsor: Karolinska Institutet

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.

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.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-30
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

Inclusion Criteria

• Obesity according to International Obesity Task Force (IOTF)

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in degree of obesity	From start of treatment to three years follow-up	Measured by BMI standard deviation score. Digi-physical group vs. control group

Secondary Outcome Measures

Name	Time	Method
Number of physical visits	From start of treatment to three years follow-up	Visits to the clinic. Digi-physical group vs. control group
The use of the support system - weighings	From start of treatment to three years follow-up	Number of weighings/week
The use of the support system - text messages	From start of treatment to three years follow-up	Number text messages/week
Number of cancelation of physical visits	From start of treatment to three years follow-up	Visits to the clinic. Digi-physical group vs. control group
Number of patients not showing up to physical visit	From start of treatment to three years follow-up	Visits to the clinic. Digi-physical group vs. control group

Trial Locations

Locations (1)

Childrens Hospital Martina; 🇸🇪 Stockholm, Sweden