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NCT06434259 Clinical Trial

Evaluation of Long-term Digital Childhood Obesity Treatment

Childhood Obesity Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06434259
Other study ID # Evira100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date September 30, 2022

Study information
Verified date May 2024
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 428
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria: - Obesity according to International Obesity Task Force (IOTF) Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Digi-physical support system
A support system named Evira will be used to provide behavioral treatment.

Locations
Country Name City State
Sweden Childrens Hospital Martina Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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 (L — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in degree of obesity Measured by BMI standard deviation score. Digi-physical group vs. control group From start of treatment to three years follow-up
Secondary The use of the support system - weighings Number of weighings/week From start of treatment to three years follow-up
Secondary The use of the support system - text messages Number text messages/week From start of treatment to three years follow-up
Secondary Number of physical visits Visits to the clinic. Digi-physical group vs. control group From start of treatment to three years follow-up
Secondary Number of cancelation of physical visits Visits to the clinic. Digi-physical group vs. control group From start of treatment to three years follow-up
Secondary Number of patients not showing up to physical visit Visits to the clinic. Digi-physical group vs. control group From start of treatment to three years follow-up
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