Clinical trial NCT03380598: 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
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Mobile Health, Self-Monitoring, Behavioural Treatment
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 28
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Familie's experience and feasibility of the treatment
timeFrame: 6 months after baseline
Secondary outcomes:
measure: Health care professional's required working time for control vs intervention
timeFrame: During the intervention 6 months
measure: Health care professional's experience using the web based support system
timeFrame: During the intervention 3 and 6 months
Other outcomes:
measure: Change in BMI Standard Deviation Score
timeFrame: During the intervention 3 and 6 months
measure: Familie's compliance
timeFrame: During the intervention 6 months
Locations:
city: Huddinge
country: Sweden
facility: National Childhood Obesity Center, Karolinska University hospital
city: Norrtälje
country: Sweden
facility: Outpatient paediatric clinic at Norrtälje Hospital
city: Södertälje
country: Sweden
facility: Outpatient paediatric clinic at Södertälje Hospital
Study officials:
affiliation: Karolinska Institutet
name: Pernilla Danielsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.