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Clinical Trials/NCT03380598
NCT03380598
Completed
Not Applicable

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

Karolinska Institutet3 sites in 1 country28 target enrollmentSeptember 20, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Obesity
Sponsor
Karolinska Institutet
Enrollment
28
Locations
3
Primary Endpoint
Familie's experience and feasibility of the treatment
Status
Completed
Last Updated
6 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2017
End Date
September 24, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pernilla Danielsson

PhD Pediatric Nurse

Karolinska Institutet

Eligibility Criteria

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

Outcomes

Primary Outcomes

Familie's experience and feasibility of the treatment

Time Frame: 6 months after baseline

CLOSS specific questionnaire, control vs intervention

Secondary Outcomes

  • Health care professional's experience using the web based support system(During the intervention 3 and 6 months)
  • Health care professional's required working time for control vs intervention(During the intervention 6 months)

Study Sites (3)

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