Treatment Results and Health Care Consumption From a Web-based Support System in Behavioural Childhood Obesity Treatment
1 other identifier
interventional
82
1 country
10
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2018
CompletedFirst Submitted
Initial submission to the registry
June 7, 2018
CompletedFirst Posted
Study publicly available on registry
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2019
CompletedApril 8, 2020
April 1, 2020
1.6 years
June 7, 2018
April 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in degree of obesity
Measured by BMI standard deviation score control vs intervention
6 and 12 months after baseline
Secondary Outcomes (6)
Number of physical visits
During the intervention 12 months
Cancelation of physical visits
During the intervention 12 months
Time consumption for the health care professionals
During the intervention 12 months
Parental experience of treatment
During the intervention 3, 6 and 12 months
Health care professional's experiences using the web-based support system
During the intervention 3, 6 and 12 months
- +1 more secondary outcomes
Study Arms (2)
Usual care
ACTIVE COMPARATORUsual care according to regular treatment routines at the clinic during 12 months
CLOSS
ACTIVE COMPARATORUsual care plus using a web-based support system for self-monitoring weight, physical activity and communication with the clinic during 12 months
Interventions
The child and parent(s) at regular visits to the pediatric clinic for childhood obesity treatment
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diagnosed with or undergoing assessment of neuropsychiatric disorder
- Hypothalamic obesity
- Pharmacological treatment that could intervene the obesity treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Outpatient pediatric clinic at Hisingen
Gothenburg, Sweden
Outpatient pediatric clinic in Kungshöjd
Gothenburg, Sweden
Outpatient pediatric clinic at Hässleholm hospital
Hässleholm, Sweden
Outpatient pediatric clinic at Helsingborg hospital
Helsingborg, Sweden
Outpatient pediatric clinic, Hälsan Barnmottagning
Jönköping, Sweden
Outpatient pediatric clinic at Karlstad hospital
Karlstad, Sweden
Outpatient pediatric clinic at Nacka hospital
Stockholm, Sweden
Pediatric clinic, Umeå University Hospital
Umeå, Sweden
Outpatient pediatric clinic at Västerås central hospital
Västerås, Sweden
Outpatient pediatric clinic at Ystad hospital
Ystad, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pernilla Danielsson, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 7, 2018
First Posted
June 25, 2018
Study Start
April 11, 2018
Primary Completion
November 26, 2019
Study Completion
November 26, 2019
Last Updated
April 8, 2020
Record last verified: 2020-04