Evaluation of a Digital Childhood Obesity Treatment

Childhood Obesity Clinical Trial

Official title:

One Year Evaluation of a Web-based System for Optimization of Behavioural Childhood Obesity Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323215
• Other study ID #: Provement100
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: May 1, 2020

Study information

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

Clinical Trial Summary

This study aims to evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the number of missed visits.

Description:

Childhood obesity treatment is time consuming for both the health care system, and for the involved families. There is an association between the intensity and the outcome of treatment. In this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. The digital support system includes daily weighing on scales that do not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individual target curve visualizing the expected weight journey. Weight in growing children is complex to interpret why BMI SDS is used. Objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app. The evaluation will be carried out when approximately 120 children have had the opportunity to be treated with the support system for one year. The results will be compared with a matched control group from the BORIS childhood obesity treatment register.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: May 1, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• Obesity according to International Obesity Task Force (IOTF)

Exclusion Criteria:

• No

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity
• Treatment Adherence

Intervention

Device:
• Support system
A support system named Provement will be used to provide behavioral treatment.

Locations

Country	Name	City	State
Sweden	Childrens hospital Martina	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in degree of obesity	Measured by BMI standard deviation score. Support system users vs control	From start of treatment to one year follow-up
Secondary	The use of the support system - weighings	Number of weighings/week	From start of treatment to one year follow-up
Secondary	The use of the support system - text messages	Number text messages/week	From start of treatment to one year follow-up
Secondary	Number of physical visits	Visits to the clinic. Support system users vs control	From start of treatment to one year follow-up
Secondary	Number of cancelation of physical visits	Visits to the clinic. Support system users vs control	From start of treatment to one year follow-up
Secondary	Number of patients not showing up to physical visit	Visits to the clinic. Support system users vs control	From start of treatment to one year follow-up