Evaluation of a Digital Childhood Obesity Treatment

November 19, 2020 updated by: Pernilla Danielsson, Karolinska Institutet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Childrens hospital Martina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children who start treatment for childhood obesity at Martina children Hospital will use a digital support system as a complement to behavioral treatment. Approximately 120 children 3-18 years will be included in this first evaluation.

Description

Inclusion Criteria:

  • Obesity according to International Obesity Task Force (IOTF)

Exclusion Criteria:

  • No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Control group
Children treated with usual care according to regular treatment routines registred in BORIS the Swedish childhood obesity treatment register

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From start of treatment to one year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The use of the support system - weighings
Time Frame: From start of treatment to one year follow-up
Number of weighings/week
From start of treatment to one year follow-up
The use of the support system - text messages
Time Frame: From start of treatment to one year follow-up
Number text messages/week
From start of treatment to one year follow-up
Number of physical visits
Time Frame: From start of treatment to one year follow-up
Visits to the clinic. Support system users vs control
From start of treatment to one year follow-up
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
From start of treatment to one year follow-up
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
From start of treatment to one year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Pernilla Danielsson, PhD, Karolinska Institutet, CLINTEC, Division of pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 26, 2020

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Provement100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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