Treatment Results and Health Care Consumption From a Web-based Support System in Behavioural Childhood Obesity Treatment

Study Overview
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Brief Summary
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This study aims to evaluate if a web-based support system with daily self-monitoring of weight, use of an activity measuring wrist-band, and communication between the clinic and the parents gives better results on degree of obesity compared with usual care. Changes in BMI standard deviation score (SDS) 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 will be randomized to either usual care according to regular routine (control) or to usual care plus a web-based support system (intervention). Based on previous reviews on mobile health and obesity in combination with the investigators' experiences of childhood obesity treatment components were identified which the researchers hypothesize are of major importance for a web-based system for childhood obesity treatment: Frequent self-monitoring of weight and physical activity, goals for weight loss, and feedback from the treatment team. The system is based on a smart phone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smart phone, where data is presented graphically. The data is further transferred to the clinic for support and communication between the clinic and the parents. The randomization will be done at the start of individual treatment and will last for 12 months. The main aim is to evaluate if use of the web-based support system will give better results on degree of obesity compared with usual care.

Official Title
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Treatment Results and Health Care Consumption From a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Multicentre Trial of Childhood Obesity Treatment

Conditions
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Childhood Obesity

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


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 Patients new in treatment or in treatment during the past 9-15 months with a decrease of BMI SDS with ≤0.25 Exclusion Criteria: Diagnosed with or undergoing assessment of neuropsychiatric disorder Hypothalamic obesity Pharmacological treatment that could intervene the obesity treatment

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 12 months | Behavioral: Usual care<br>* The child and parent(s) at regular visits to the pediatric clinic for childhood obesity treatment<br>|
| Active Comparator: CLOSS<br>Usual care plus using a web-based support system for self-monitoring weight, physical activity and communication with the clinic during 12 months | Behavioral: CLOSS<br>* Usual care plus using mobile applications to register weight and physical activity as well as for communication with the clinic. A web-based support system enables health care professionals to follow the patient's daily objectively measured weight and physical activity online.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in degree of obesity | Measured by BMI standard deviation score control vs intervention | 6 and 12 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of physical visits | Control vs intervention | During the intervention 12 months | 
| Cancelation of physical visits | Control vs intervention | During the intervention 12 months | 
| Time consumption for the health care professionals | Time for physical visits, communication and documentation reported by health care professionals. Control vs intervention | During the intervention 12 months | 
| Parental experience of treatment | Measured by web-based CLOSS specific questions. Control vs intervention | During the intervention 3, 6 and 12 months | 
| Health care professional's experiences using the web-based support system | CLOSS specific questions regarding the application | During the intervention 3, 6 and 12 months | 
| Physical activity level | Measured by time and intensity through the activity measuring wrist-band. Only intervention | During the intervention 12 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