Back to resultsAn Evaluation of a Web-based System for Optimization of Behavioral Childhood Obesity Treatment
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CLOSS
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Mobile Health, Self-Monitoring, Behavioural Treatment
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
Sites / Locations
- National Childhood Obesity Center, Karolinska University hospital
- Outpatient paediatric clinic at Norrtälje Hospital
- Outpatient paediatric clinic at Södertälje Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Usual care
CLOSS
Arm Description
Usual care according to regular treatment routines at the clinic during 6 months.
Usual care plus using a web based support system for self-monitoring weight at physical activity.
Outcomes
Primary Outcome Measures
Familie's experience and feasibility of the treatment
CLOSS specific questionnaire, control vs intervention
Secondary Outcome Measures
Health care professional's required working time for control vs intervention
Time report
Health care professional's experience using the web based support system
CLOSS specific questions regarding the application
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03380598
Brief Title
An Evaluation of a Web-based System for Optimization of Behavioral Childhood Obesity Treatment
Official Title
An Evaluation of a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Trial of Childhood Obesity Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
September 24, 2018 (Actual)
Study Completion Date
September 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Mobile Health, Self-Monitoring, Behavioural Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care according to regular treatment routines at the clinic during 6 months.
Arm Title
CLOSS
Arm Type
Active Comparator
Arm Description
Usual care plus using a web based support system for self-monitoring weight at physical activity.
Intervention Type
Behavioral
Intervention Name(s)
CLOSS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual care. The child and parent(s) at regular visits to the nurse at the clinic
Primary Outcome Measure Information:
Title
Familie's experience and feasibility of the treatment
Description
CLOSS specific questionnaire, control vs intervention
Time Frame
6 months after baseline
Secondary Outcome Measure Information:
Title
Health care professional's required working time for control vs intervention
Description
Time report
Time Frame
During the intervention 6 months
Title
Health care professional's experience using the web based support system
Description
CLOSS specific questions regarding the application
Time Frame
During the intervention 3 and 6 months
Other Pre-specified Outcome Measures:
Title
Change in BMI Standard Deviation Score
Description
Control vs intervention
Time Frame
During the intervention 3 and 6 months
Title
Familie's compliance
Description
Control - visits to the clinic Intervention - daily weighing, daily usage of accelerometer, and visits to the clinic
Time Frame
During the intervention 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernilla Danielsson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Childhood Obesity Center, Karolinska University hospital
City
Huddinge
Country
Sweden
Facility Name
Outpatient paediatric clinic at Norrtälje Hospital
City
Norrtälje
Country
Sweden
Facility Name
Outpatient paediatric clinic at Södertälje Hospital
City
Södertälje
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
32967638
Citation
Johansson L, Hagman E, Danielsson P. A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial. BMC Pediatr. 2020 Sep 23;20(1):447. doi: 10.1186/s12887-020-02338-9.
Results Reference
derived
Learn more about this trial
An Evaluation of a Web-based System for Optimization of Behavioral Childhood Obesity Treatment
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