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

Childhood Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566771
• Other study ID #: CLOSS200
• Status: Completed
• Phase: N/A
• Start date: April 11, 2018
• Est. completion date: November 26, 2019

Study information

• Verified date: April 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Usual care
The child and parent(s) at regular visits to the pediatric clinic for childhood obesity treatment
• CLOSS
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.

Locations

Country	Name	City	State
Sweden	Outpatient pediatric clinic at Hisingen	Göteborg
Sweden	Outpatient pediatric clinic in Kungshöjd	Göteborg
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

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in degree of obesity	Measured by BMI standard deviation score control vs intervention	6 and 12 months after baseline
Secondary	Number of physical visits	Control vs intervention	During the intervention 12 months
Secondary	Cancelation of physical visits	Control vs intervention	During the intervention 12 months
Secondary	Time consumption for the health care professionals	Time for physical visits, communication and documentation reported by health care professionals. Control vs intervention	During the intervention 12 months
Secondary	Parental experience of treatment	Measured by web-based CLOSS specific questions. Control vs intervention	During the intervention 3, 6 and 12 months
Secondary	Health care professional's experiences using the web-based support system	CLOSS specific questions regarding the application	During the intervention 3, 6 and 12 months
Secondary	Physical activity level	Measured by time and intensity through the activity measuring wrist-band. Only intervention	During the intervention 12 months