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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Usual care according to regular treatment routines at the clinic during 12 months |
|
| CLOSS | Active Comparator | Usual care plus using a web-based support system for self-monitoring weight, physical activity and communication with the clinic during 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Behavioral | The child and parent(s) at regular visits to the pediatric clinic for childhood obesity treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in degree of obesity | Measured by BMI standard deviation score control vs intervention | 6 and 12 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of physical visits | Control vs intervention | During the intervention 12 months |
| Cancelation of physical visits | Control vs intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pernilla Danielsson, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient pediatric clinic at Hisingen | Gothenburg | Sweden | ||||
| Outpatient pediatric clinic in Kungshöjd |
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| CLOSS | Behavioral | 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. |
|
| 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 |
| Gothenburg |
| Sweden |
| Outpatient pediatric clinic at Hässleholm hospital | Hässleholm | Sweden |
| Outpatient pediatric clinic at Helsingborg hospital | Helsingborg | Sweden |
| Outpatient pediatric clinic, Hälsan Barnmottagning | Jönköping | Sweden |
| Outpatient pediatric clinic at Karlstad hospital | Karlstad | Sweden |
| Outpatient pediatric clinic at Nacka hospital | Stockholm | Sweden |
| Pediatric clinic, Umeå University Hospital | Umeå | Sweden |
| Outpatient pediatric clinic at Västerås central hospital | Västerås | Sweden |
| Outpatient pediatric clinic at Ystad hospital | Ystad | Sweden |
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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