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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Control group | Children treated with usual care according to regular treatment routines registered in the Swedish childhood obesity treatment register, BORIS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digi-physical support system | Device | A support system named Evira will be used to provide behavioral treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The use of the support system - weighings | Number of weighings/week | From start of treatment to three years follow-up |
| The use of the support system - text messages | Number text messages/week |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pernilla Danielsson Liljeqvist, PhD | Karolinska Institutet, CLINTEC, Division of pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Martina | Stockholm | 114 28 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35641569 | Result | 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. | |
| 40075128 |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| From start of treatment to three years follow-up |
| Number of physical visits | Visits to the clinic. Digi-physical group vs. control group | From start of treatment to three years follow-up |
| 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 |
| 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 |
| Hagman E, Lindberg L, Putri RR, Drangel A, Marcus C, Danielsson P. Long-term results of a digital treatment tool as an add-on to pediatric obesity lifestyle treatment: a 3-year pragmatic clinical trial. Int J Obes (Lond). 2025 May;49(5):973-976. doi: 10.1038/s41366-025-01738-0. Epub 2025 Mar 12. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015438 | Health Behavior |
| D001519 | Behavior |