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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03380598
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : April 8, 2020
Information provided by (Responsible Party):
Pernilla Danielsson, Karolinska Institutet

Brief 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).

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: CLOSS Behavioral: Usual care Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Trial of Childhood Obesity Treatment
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : September 24, 2018
Actual Study Completion Date : September 24, 2018

Arm Intervention/treatment
Active Comparator: Usual care
Usual care according to regular treatment routines at the clinic during 6 months.
Behavioral: Usual care
Usual care. The child and parent(s) at regular visits to the nurse at the clinic

Active Comparator: CLOSS
Usual care plus using a web based support system for self-monitoring weight at physical activity.
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.

Primary Outcome Measures :
  1. Familie's experience and feasibility of the treatment [ Time Frame: 6 months after baseline ]
    CLOSS specific questionnaire, control vs intervention

Secondary Outcome Measures :
  1. Health care professional's required working time for control vs intervention [ Time Frame: During the intervention 6 months ]
    Time report

  2. Health care professional's experience using the web based support system [ Time Frame: During the intervention 3 and 6 months ]
    CLOSS specific questions regarding the application

Other Outcome Measures:
  1. Change in BMI Standard Deviation Score [ Time Frame: During the intervention 3 and 6 months ]
    Control vs intervention

  2. Familie's compliance [ Time Frame: During the intervention 6 months ]
    Control - visits to the clinic Intervention - daily weighing, daily usage of accelerometer, and visits to the clinic

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03380598

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National Childhood Obesity Center, Karolinska University hospital
Huddinge, Sweden
Outpatient paediatric clinic at Norrtälje Hospital
Norrtälje, Sweden
Outpatient paediatric clinic at Södertälje Hospital
Södertälje, Sweden
Sponsors and Collaborators
Karolinska Institutet
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Principal Investigator: Pernilla Danielsson, PhD Karolinska Institutet
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pernilla Danielsson, PhD Pediatric Nurse, Karolinska Institutet Identifier: NCT03380598    
Other Study ID Numbers: CLOSS100
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pernilla Danielsson, Karolinska Institutet:
Mobile Health, Self-Monitoring, Behavioural Treatment
Additional relevant MeSH terms:
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Pediatric Obesity
Nutrition Disorders
Body Weight