Clinical trial NCT04323215: Evaluation of a Digital Childhood Obesity Treatment
Official title: One Year Evaluation of a Web-based System for Optimization of Behavioural Childhood Obesity Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Treatment Adherence
Keywords: Mobile Health
Support System
Behavioral treatment
Self-Monitoring
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 156
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children who start treatment for childhood obesity at Martina children Hospital will use a digital support system as a complement to behavioral treatment. Approximately 120 children 3-18 years will be included in this first evaluation.

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 evaluation will be carried out when approximately 120 children have had the opportunity to be treated with the support system for one year. The results will be compared with a matched control group from the BORIS childhood obesity treatment register.

Eligibility criteria: Inclusion Criteria:

* Obesity according to International Obesity Task Force (IOTF)

Exclusion Criteria:

* No

Primary outcomes:
measure: Change in degree of obesity
timeFrame: From start of treatment to one year follow-up
Secondary outcomes:
measure: The use of the support system - weighings
timeFrame: From start of treatment to one year follow-up
measure: The use of the support system - text messages
timeFrame: From start of treatment to one year follow-up
measure: Number of physical visits
timeFrame: From start of treatment to one year follow-up
measure: Number of cancelation of physical visits
timeFrame: From start of treatment to one year follow-up
measure: Number of patients not showing up to physical visit
timeFrame: From start of treatment to one year follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Childrens hospital Martina
Study officials:
affiliation: Karolinska Institutet, CLINTEC, Division of pediatrics
name: Pernilla Danielsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.