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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06434259
Enrollment
428
Registered
2024-05-30
Start date
2018-09-01
Completion date
2022-09-30
Last updated
2024-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Treatment Adherence

Keywords

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

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.

Interventions

DEVICEDigi-physical support system

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

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years

Inclusion criteria

* Obesity according to International Obesity Task Force (IOTF)

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Change in degree of obesityFrom start of treatment to three years follow-upMeasured by BMI standard deviation score. Digi-physical group vs. control group

Secondary

MeasureTime frameDescription
The use of the support system - weighingsFrom start of treatment to three years follow-upNumber of weighings/week
The use of the support system - text messagesFrom start of treatment to three years follow-upNumber text messages/week
Number of physical visitsFrom start of treatment to three years follow-upVisits to the clinic. Digi-physical group vs. control group
Number of cancelation of physical visitsFrom start of treatment to three years follow-upVisits to the clinic. Digi-physical group vs. control group
Number of patients not showing up to physical visitFrom start of treatment to three years follow-upVisits to the clinic. Digi-physical group vs. control group

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026