Evaluation of Long-term Digital Childhood Obesity Treatment

May 30, 2024 updated by: Pernilla Danielsson, Karolinska Institutet

Long-term Results of an Interactive Mobile Health Support System and Daily Home-weighing as an add-on to Pediatric Obesity Lifestyle Treatment: A 3-year Pragmatic Clinical Trial

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 present study is a continuation of the investigators previous one-year study, Clinicaltrials.gov ID: NCT04323215. In this follow-up study, the investigators aim to assess the treatment outcomes over a three-year period.

The evaluation will be carried out on 107 children who underwent digi-physical treatment for three years. The results will be compared with a matched control group (n=321) from the Swedish childhood obesity treatment register, BORIS.

Study Type

Observational

Enrollment (Actual)

428

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, 114 28
        • 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

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

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. 107 children in the digit-physical group and 321 children in the control group, aged 4-17.9 years, will be included.

Description

Inclusion Criteria:

  • Obesity according to International Obesity Task Force (IOTF)

Exclusion Criteria:

  • None

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
Digi-physical treatment group
Usual care (behavioral treatment) plus the support system for self- monitoring of weight and communication with the clinic during three years of treatment.
Device: Digi-physical support system
A support system named Evira will be used to provide behavioral treatment.
Control group
Children treated with usual care according to regular treatment routines registered in the Swedish childhood obesity treatment register, BORIS

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 three years follow-up
Measured by BMI standard deviation score. Digi-physical group vs. control group
From start of treatment to three years 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 three years follow-up
Number of weighings/week
From start of treatment to three years follow-up
The use of the support system - text messages
Time Frame: From start of treatment to three years follow-up
Number text messages/week
From start of treatment to three years follow-up
Number of physical visits
Time Frame: From start of treatment to three years follow-up
Visits to the clinic. Digi-physical group vs. control group
From start of treatment to three years follow-up
Number of cancelation of physical visits
Time Frame: From start of treatment to three years follow-up
Visits to the clinic. Digi-physical group vs. control group
From start of treatment to three years follow-up
Number of patients not showing up to physical visit
Time Frame: From start of treatment to three years follow-up
Visits to the clinic. Digi-physical group vs. control group
From start of treatment to three years 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 Liljeqvist, 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)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Evira100

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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