An Evaluation of a Web-based System for Optimization of Behavioral Childhood Obesity Treatment

Study Overview
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Brief Summary
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This study evaluates the families' and health care professional's experience from using a web based support system including mobile applications for self-monitoring weight and physical activity. Changes in BMI standard deviation score are compared between usual care (control) and usual care with complementary web-based support system (intervention).

Detailed Description
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In this study children with obesity were randomized to either usual care according to regular routine (control group) or to usual care plus a web-based support system (intervention group). The system is based on a smartphone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smartphone, where data is presented graphically. The data is transferred to the clinic for support. The system is developed for communication between the clinic and family. The randomization was done at the start of individual treatment and lasted for 6 months. Investigators studied the families and health care professional's experience of using the web-based support system as well as changes in BMI standard deviation score in the control and intervention group.

Official Title
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An Evaluation of a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Trial of Childhood Obesity Treatment

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: CLOSS
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obesity according to International Obesity Task Force (IOTF) Swedish speaking parents Parents able to use a smart phone No pharmacological treatment that could intervene the obesity treatment Exclusion Criteria: Diagnosed with or undergoing assessment of neuropsychiatric disorder Structured obesity treatment the past 6 months Hypothalamic obesity

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Usual care according to regular treatment routines at the clinic during 6 months. | Behavioral: Usual care<br>* Usual care. The child and parent(s) at regular visits to the nurse at the clinic<br>|
| Active Comparator: CLOSS<br>Usual care plus using a web based support system for self-monitoring weight at physical activity. | Behavioral: CLOSS<br>* Usual care plus using mobile application's to register weight and physical activity as well as for communication with the clinic. A web-based system enables health care professionals to follow the the patient's daily weight registration online.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Familie's experience and feasibility of the treatment | CLOSS specific questionnaire, control vs intervention | 6 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care professional's required working time for control vs intervention | Time report | During the intervention 6 months | 
| Health care professional's experience using the web based support system | CLOSS specific questions regarding the application | During the intervention 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile Health, Self-Monitoring, Behavioural Treatment