Evaluation of a Digital Childhood Obesity Treatment

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT04323215
Collaborator
(none)
156
1
20
7.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Support system

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 Design

Study Type:
Observational
Actual Enrollment :
156 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
One Year Evaluation of a Web-based System for Optimization of Behavioural Childhood Obesity Treatment
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. The use of the support system - weighings [From start of treatment to one year follow-up]

    Number of weighings/week

  2. The use of the support system - text messages [From start of treatment to one year follow-up]

    Number text messages/week

  3. Number of physical visits [From start of treatment to one year follow-up]

    Visits to the clinic. Support system users vs control

  4. Number of cancelation of physical visits [From start of treatment to one year follow-up]

    Visits to the clinic. Support system users vs control

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Obesity according to International Obesity Task Force (IOTF)
Exclusion Criteria:
  • No

Contacts and Locations

Locations

Site City State Country Postal Code
1 Childrens hospital Martina Stockholm Sweden

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pernilla Danielsson, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04323215
Other Study ID Numbers:
  • Provement100
First Posted:
Mar 26, 2020
Last Update Posted:
Nov 23, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pernilla Danielsson, Principal Investigator, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2020