Evaluation of Long-term Digital Childhood Obesity Treatment
NCT ID: NCT06434259
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
428 participants
OBSERVATIONAL
2018-09-01
2022-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Digi-physical support system
A support system named Evira will be used to provide behavioral treatment.
Control group
Children treated with usual care according to regular treatment routines registered in the Swedish childhood obesity treatment register, BORIS
No interventions assigned to this group
Interventions
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Digi-physical support system
A support system named Evira will be used to provide behavioral treatment.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Years
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Pernilla Danielsson
Principal Investigator
Principal Investigators
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Pernilla Danielsson Liljeqvist, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet, CLINTEC, Division of pediatrics
Locations
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Childrens Hospital Martina
Stockholm, , Sweden
Countries
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References
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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.
Other Identifiers
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Evira100
Identifier Type: -
Identifier Source: org_study_id
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