Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434259
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-05-23
Brief Title:
Evaluation of Long-term Digital Childhood Obesity Treatment
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 present study is a continuation of the investigators previous one-year study Clinicaltrialsgov 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 n321 from the Swedish childhood obesity treatment register BORIS
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 Clinicaltrialsgov 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 n321 from the Swedish childhood obesity treatment register BORIS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None