Clinical trial NCT06434259: Evaluation of Long-term Digital Childhood Obesity Treatment
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
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: 2024-05-30
Enrollment: 428
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
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. 107 children in the digit-physical group and 321 children in the control group, aged 4-17.9 years, will be included.

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.

Eligibility criteria: Inclusion Criteria:

* Obesity according to International Obesity Task Force (IOTF)

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in degree of obesity
timeFrame: From start of treatment to three years follow-up
Secondary outcomes:
measure: The use of the support system - weighings
timeFrame: From start of treatment to three years follow-up
measure: The use of the support system - text messages
timeFrame: From start of treatment to three years follow-up
measure: Number of physical visits
timeFrame: From start of treatment to three years follow-up
measure: Number of cancelation of physical visits
timeFrame: From start of treatment to three years follow-up
measure: Number of patients not showing up to physical visit
timeFrame: From start of treatment to three years 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 Liljeqvist, 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.