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Treatment Results and Health Care Consumption From a Web-based Support System in Behavioural Childhood Obesity Treatment

Treatment Results and Health Care Consumption From a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Multicentre Trial of Childhood Obesity Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03566771
Enrollment
82
Registered
2018-06-25
Start date
2018-04-11
Completion date
2019-11-26
Last updated
2020-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Keywords

Mobile Health, Self-Monitoring, Behavioural 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.

Interventions

BEHAVIORALUsual care

The child and parent(s) at regular visits to the pediatric clinic for childhood obesity treatment

BEHAVIORALCLOSS

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.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in degree of obesity6 and 12 months after baselineMeasured by BMI standard deviation score control vs intervention

Secondary

MeasureTime frameDescription
Cancelation of physical visitsDuring the intervention 12 monthsControl vs intervention
Time consumption for the health care professionalsDuring the intervention 12 monthsTime for physical visits, communication and documentation reported by health care professionals. Control vs intervention
Number of physical visitsDuring the intervention 12 monthsControl vs intervention
Health care professional's experiences using the web-based support systemDuring the intervention 3, 6 and 12 monthsCLOSS specific questions regarding the application
Physical activity levelDuring the intervention 12 monthsMeasured by time and intensity through the activity measuring wrist-band. Only intervention
Parental experience of treatmentDuring the intervention 3, 6 and 12 monthsMeasured by web-based CLOSS specific questions. Control vs intervention

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026