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NCT03380598 Clinical Trial

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

Childhood Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03380598
Other study ID # CLOSS100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2017
Est. completion date September 24, 2018

Study information
Verified date April 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date September 24, 2018
Est. primary completion date September 24, 2018
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• CLOSS
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.
• Usual care
Usual care. The child and parent(s) at regular visits to the nurse at the clinic

Locations
Country Name City State
Sweden National Childhood Obesity Center, Karolinska University hospital Huddinge
Sweden Outpatient paediatric clinic at Norrtälje Hospital Norrtälje
Sweden Outpatient paediatric clinic at Södertälje Hospital Södertälje

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Other Change in BMI Standard Deviation Score Control vs intervention During the intervention 3 and 6 months
Other Familie's compliance Control - visits to the clinic Intervention - daily weighing, daily usage of accelerometer, and visits to the clinic During the intervention 6 months
Primary Familie's experience and feasibility of the treatment CLOSS specific questionnaire, control vs intervention 6 months after baseline
Secondary Health care professional's required working time for control vs intervention Time report During the intervention 6 months
Secondary Health care professional's experience using the web based support system CLOSS specific questions regarding the application During the intervention 3 and 6 months
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