Back to resultsTreatment Results and Health Care Consumption From a Web-based Support System in Behavioural Childhood Obesity Treatment
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Usual care
CLOSS
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
- Patients new in treatment or in treatment during the past 9-15 months with a decrease of BMI SDS with ≤0.25
Exclusion Criteria:
- Diagnosed with or undergoing assessment of neuropsychiatric disorder
- Hypothalamic obesity
- Pharmacological treatment that could intervene the obesity treatment
Sites / Locations
- Outpatient pediatric clinic at Hisingen
- Outpatient pediatric clinic in Kungshöjd
- Outpatient pediatric clinic at Helsingborg hospital
- Outpatient pediatric clinic at Hässleholm hospital
- Outpatient pediatric clinic, Hälsan Barnmottagning
- Outpatient pediatric clinic at Karlstad hospital
- Outpatient pediatric clinic at Nacka hospital
- Pediatric clinic, Umeå University Hospital
- Outpatient pediatric clinic at Västerås central hospital
- Outpatient pediatric clinic at Ystad 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 12 months
Usual care plus using a web-based support system for self-monitoring weight, physical activity and communication with the clinic during 12 months
Outcomes
Primary Outcome Measures
Changes in degree of obesity
Measured by BMI standard deviation score control vs intervention
Secondary Outcome Measures
Number of physical visits
Control vs intervention
Cancelation of physical visits
Control vs intervention
Time consumption for the health care professionals
Time for physical visits, communication and documentation reported by health care professionals. Control vs intervention
Parental experience of treatment
Measured by web-based CLOSS specific questions. Control vs intervention
Health care professional's experiences using the web-based support system
CLOSS specific questions regarding the application
Physical activity level
Measured by time and intensity through the activity measuring wrist-band. Only intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03566771
Brief Title
Treatment Results and Health Care Consumption From a Web-based Support System in Behavioural Childhood Obesity Treatment
Official Title
Treatment Results and Health Care Consumption From a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Multicentre Trial of Childhood Obesity Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
November 26, 2019 (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 aims to evaluate if a web-based support system with daily self-monitoring of weight, use of an activity measuring wrist-band, and communication between the clinic and the parents gives better results on degree of obesity compared with usual care. Changes in BMI standard deviation score (SDS) are compared between usual care (control) and usual care with complementary web-based support system (intervention).
Detailed Description
In this study children with obesity will be randomized to either usual care according to regular routine (control) or to usual care plus a web-based support system (intervention). Based on previous reviews on mobile health and obesity in combination with the investigators' experiences of childhood obesity treatment components were identified which the researchers hypothesize are of major importance for a web-based system for childhood obesity treatment: Frequent self-monitoring of weight and physical activity, goals for weight loss, and feedback from the treatment team. The system is based on a smart phone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smart phone, where data is presented graphically. The data is further transferred to the clinic for support and communication between the clinic and the parents. The randomization will be done at the start of individual treatment and will last for 12 months. The main aim is to evaluate if use of the web-based support system will give better results on degree of obesity compared with usual care.
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
82 (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 12 months
Arm Title
CLOSS
Arm Type
Active Comparator
Arm Description
Usual care plus using a web-based support system for self-monitoring weight, physical activity and communication with the clinic during 12 months
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
The child and parent(s) at regular visits to the pediatric clinic for childhood obesity treatment
Intervention Type
Behavioral
Intervention Name(s)
CLOSS
Intervention Description
Usual care plus using mobile applications to register weight and physical activity as well as for communication with the clinic. A web-based support system enables health care professionals to follow the patient's daily objectively measured weight and physical activity online.
Primary Outcome Measure Information:
Title
Changes in degree of obesity
Description
Measured by BMI standard deviation score control vs intervention
Time Frame
6 and 12 months after baseline
Secondary Outcome Measure Information:
Title
Number of physical visits
Description
Control vs intervention
Time Frame
During the intervention 12 months
Title
Cancelation of physical visits
Description
Control vs intervention
Time Frame
During the intervention 12 months
Title
Time consumption for the health care professionals
Description
Time for physical visits, communication and documentation reported by health care professionals. Control vs intervention
Time Frame
During the intervention 12 months
Title
Parental experience of treatment
Description
Measured by web-based CLOSS specific questions. Control vs intervention
Time Frame
During the intervention 3, 6 and 12 months
Title
Health care professional's experiences using the web-based support system
Description
CLOSS specific questions regarding the application
Time Frame
During the intervention 3, 6 and 12 months
Title
Physical activity level
Description
Measured by time and intensity through the activity measuring wrist-band. Only intervention
Time Frame
During the intervention 12 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
Patients new in treatment or in treatment during the past 9-15 months with a decrease of BMI SDS with ≤0.25
Exclusion Criteria:
Diagnosed with or undergoing assessment of neuropsychiatric disorder
Hypothalamic obesity
Pharmacological treatment that could intervene the obesity treatment
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
Outpatient pediatric clinic at Hisingen
City
Göteborg
Country
Sweden
Facility Name
Outpatient pediatric clinic in Kungshöjd
City
Göteborg
Country
Sweden
Facility Name
Outpatient pediatric clinic at Helsingborg hospital
City
Helsingborg
Country
Sweden
Facility Name
Outpatient pediatric clinic at Hässleholm hospital
City
Hässleholm
Country
Sweden
Facility Name
Outpatient pediatric clinic, Hälsan Barnmottagning
City
Jönköping
Country
Sweden
Facility Name
Outpatient pediatric clinic at Karlstad hospital
City
Karlstad
Country
Sweden
Facility Name
Outpatient pediatric clinic at Nacka hospital
City
Stockholm
Country
Sweden
Facility Name
Pediatric clinic, Umeå University Hospital
City
Umeå
Country
Sweden
Facility Name
Outpatient pediatric clinic at Västerås central hospital
City
Västerås
Country
Sweden
Facility Name
Outpatient pediatric clinic at Ystad hospital
City
Ystad
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Treatment Results and Health Care Consumption From a Web-based Support System in Behavioural Childhood Obesity Treatment
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