Evaluation of a Digital Childhood Obesity Treatment
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|ClinicalTrials.gov Identifier: NCT04323215|
Recruitment Status : Completed
First Posted : March 26, 2020
Last Update Posted : November 23, 2020
|Condition or disease||Intervention/treatment|
|Childhood Obesity Treatment Adherence||Device: Support system|
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.
|Study Type :||Observational|
|Actual Enrollment :||156 participants|
|Official Title:||One Year Evaluation of a Web-based System for Optimization of Behavioural Childhood Obesity Treatment|
|Actual Study Start Date :||September 1, 2018|
|Actual Primary Completion Date :||March 31, 2020|
|Actual Study Completion Date :||May 1, 2020|
Support system users
Usual care (behavioral treatment) plus the support system for self-monitoring of weight and communication with the clinic during one year of treatment.
Device: Support system
A support system named Provement will be used to provide behavioral treatment.
Children treated with usual care according to regular treatment routines registred in BORIS the Swedish childhood obesity treatment register
- Change in degree of obesity [ Time Frame: From start of treatment to one year follow-up ]Measured by BMI standard deviation score. Support system users vs control
- The use of the support system - weighings [ Time Frame: From start of treatment to one year follow-up ]Number of weighings/week
- The use of the support system - text messages [ Time Frame: From start of treatment to one year follow-up ]Number text messages/week
- Number of physical visits [ Time Frame: From start of treatment to one year follow-up ]Visits to the clinic. Support system users vs control
- Number of cancelation of physical visits [ Time Frame: From start of treatment to one year follow-up ]Visits to the clinic. Support system users vs control
- Number of patients not showing up to physical visit [ Time Frame: From start of treatment to one year follow-up ]Visits to the clinic. Support system users vs control
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323215
|Childrens hospital Martina|
|Principal Investigator:||Pernilla Danielsson, PhD||Karolinska Institutet, CLINTEC, Division of pediatrics|