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
• Status: Completed
• 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
• 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
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• Obesity according to International Obesity Task Force (IOTF)

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity
• Treatment Adherence

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