Evaluation of a Digital Childhood Obesity Treatment

Completed

• Conditions: Treatment Adherence; Childhood Obesity
• Interventions: Device: Support system

• Registration Number: NCT04323215
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Primary Completion: 2020-03-31
• Study Completion: 2020-05-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Obesity according to International Obesity Task Force (IOTF)

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Exclusion Criteria

• No

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Support system users	Support system	Usual care (behavioral treatment) plus the support system for self-monitoring of weight and communication with the clinic during one year of treatment.

Primary Outcome Measures

Name	Time	Method
Change in degree of obesity	From start of treatment to one year follow-up	Measured by BMI standard deviation score. Support system users vs control

Secondary Outcome Measures

Name	Time	Method
Number of cancelation of physical visits	From start of treatment to one year follow-up	Visits to the clinic. Support system users vs control
The use of the support system - text messages	From start of treatment to one year follow-up	Number text messages/week
Number of physical visits	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	From start of treatment to one year follow-up	Visits to the clinic. Support system users vs control
The use of the support system - weighings	From start of treatment to one year follow-up	Number of weighings/week

Trial Locations

Locations (1)

Childrens hospital Martina; 🇸🇪 Stockholm, Sweden