Clinical trial NCT03566771: 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
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Mobile Health
Self-Monitoring
Behavioural Treatment
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 82
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 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.

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

Primary outcomes:
measure: Changes in degree of obesity
timeFrame: 6 and 12 months after baseline
Secondary outcomes:
measure: Number of physical visits
timeFrame: During the intervention 12 months
measure: Cancelation of physical visits
timeFrame: During the intervention 12 months
measure: Time consumption for the health care professionals
timeFrame: During the intervention 12 months
measure: Parental experience of treatment
timeFrame: During the intervention 3, 6 and 12 months
measure: Health care professional's experiences using the web-based support system
timeFrame: During the intervention 3, 6 and 12 months
measure: Physical activity level
timeFrame: During the intervention 12 months
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Outpatient pediatric clinic at Hisingen
city: Göteborg
country: Sweden
facility: Outpatient pediatric clinic in Kungshöjd
city: Helsingborg
country: Sweden
facility: Outpatient pediatric clinic at Helsingborg hospital
city: Hässleholm
country: Sweden
facility: Outpatient pediatric clinic at Hässleholm hospital
city: Jönköping
country: Sweden
facility: Outpatient pediatric clinic, Hälsan Barnmottagning
city: Karlstad
country: Sweden
facility: Outpatient pediatric clinic at Karlstad hospital
city: Stockholm
country: Sweden
facility: Outpatient pediatric clinic at Nacka hospital
city: Umeå
country: Sweden
facility: Pediatric clinic, Umeå University Hospital
city: Västerås
country: Sweden
facility: Outpatient pediatric clinic at Västerås central hospital
city: Ystad
country: Sweden
facility: Outpatient pediatric clinic at Ystad hospital
Study officials:
affiliation: Karolinska Institutet
name: Pernilla Danielsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: