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

April 7, 2020 updated by: Pernilla Danielsson, Karolinska Institutet

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Huddinge, Sweden
        • National Childhood Obesity Center, Karolinska University hospital
      • Norrtälje, Sweden
        • Outpatient paediatric clinic at Norrtälje Hospital
      • Södertälje, Sweden
        • Outpatient paediatric clinic at Södertälje Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Familie's experience and feasibility of the treatment
Time Frame: 6 months after baseline
CLOSS specific questionnaire, control vs intervention
6 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health care professional's required working time for control vs intervention
Time Frame: During the intervention 6 months
Time report
During the intervention 6 months
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
During the intervention 3 and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI Standard Deviation Score
Time Frame: During the intervention 3 and 6 months
Control vs intervention
During the intervention 3 and 6 months
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
During the intervention 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Pernilla Danielsson, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2017

Primary Completion (Actual)

September 24, 2018

Study Completion (Actual)

September 24, 2018

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOSS100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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