Evaluation of a Digital Childhood Obesity Treatment
One Year Evaluation of a Web-based System for Optimization of Behavioural Childhood Obesity Treatment
1 other identifier
observational
156
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 17, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedNovember 23, 2020
November 1, 2020
1.6 years
March 17, 2020
November 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in degree of obesity
Measured by BMI standard deviation score. Support system users vs control
From start of treatment to one year follow-up
Secondary Outcomes (5)
The use of the support system - weighings
From start of treatment to one year follow-up
The use of the support system - text messages
From start of treatment to one year follow-up
Number of physical visits
From start of treatment to one year follow-up
Number of cancelation of physical visits
From start of treatment to one year follow-up
Number of patients not showing up to physical visit
From start of treatment to one year follow-up
Study Arms (2)
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.
Control group
Children treated with usual care according to regular treatment routines registred in BORIS the Swedish childhood obesity treatment register
Interventions
A support system named Provement will be used to provide behavioral treatment.
Eligibility Criteria
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.
You may qualify if:
- Obesity according to International Obesity Task Force (IOTF)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Childrens hospital Martina
Stockholm, Sweden
Related Publications (1)
Hagman E, Johansson L, Kollin C, Marcus E, Drangel A, Marcus L, Marcus C, Danielsson P. Effect of an interactive mobile health support system and daily weight measurements for pediatric obesity treatment, a 1-year pragmatical clinical trial. Int J Obes (Lond). 2022 Aug;46(8):1527-1533. doi: 10.1038/s41366-022-01146-8. Epub 2022 May 31.
PMID: 35641569DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pernilla Danielsson, PhD
Karolinska Institutet, CLINTEC, Division of pediatrics
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 17, 2020
First Posted
March 26, 2020
Study Start
September 1, 2018
Primary Completion
March 31, 2020
Study Completion
May 1, 2020
Last Updated
November 23, 2020
Record last verified: 2020-11