Evaluation of a Digital Childhood Obesity Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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One Year Evaluation of a Web-based System for Optimization of Behavioural Childhood Obesity Treatment

Conditions
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Childhood Obesity, Treatment Adherence

Intervention / Treatment
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* Device: Support system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obesity according to International Obesity Task Force (IOTF) Exclusion Criteria: No

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Support system users<br>Usual care (behavioral treatment) plus the support system for self-monitoring of weight and communication with the clinic during one year of treatment. | Device: Support system<br>* A support system named Provement will be used to provide behavioral treatment.<br>|
| Control group<br>Children treated with usual care according to regular treatment routines registred in BORIS the Swedish childhood obesity treatment register | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in degree of obesity | Measured by BMI standard deviation score. Support system users vs control | From start of treatment to one year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The use of the support system - weighings | Number of weighings/week | From start of treatment to one year follow-up | 
| The use of the support system - text messages | Number text messages/week | From start of treatment to one year follow-up | 
| Number of physical visits | Visits to the clinic. Support system users vs control | From start of treatment to one year follow-up | 
| Number of cancelation of physical visits | Visits to the clinic. Support system users vs control | From start of treatment to one year follow-up | 
| Number of patients not showing up to physical visit | Visits to the clinic. Support system users vs control | From start of treatment to one year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile Health, Support System, Behavioral treatment, Self-Monitoring