Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT05247918
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2021-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OBDIPHY (OBesity DIgital-PHYsical Care Study)
Sponsor:
Göteborg University
Organization:
Study Overview
Official Title:
OBDIPHY (OBesity DIgital-PHYsical Care Study) - Effects of Digi-physical Care for Families
Status:
COMPLETED
Status Verified Date:
2025-02
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:
OBDIPHY
Brief Summary:
This is a prospective randomized controlled multicentre non-inferiority trial. The aim of this study to evaluate digi-physical care compared to regular physical/in person care and investigate if digi-physical care can be an equal or even better treatment alternative among families with children or adolescents living with obesity in Sweden. The study participants will either get treatment as usual or treatment as usual combined with digi-physical solution. The digi-physical solution includes thar half of the session is digital and they get an app where they can self-monitoring health data, have an overview over they treatment plan and easy communicate with theirs caregivers.
Detailed Description:
This study is multi centre in three different county council in southwest of Sweden which include children and adolescents in the age of 10-16 year. The study participants will either get treatment as usual, which includes four in person session with healthcare professionals as doctor, nurse or dietitian (the control group) or treatment as usual combined with digi-physical solution (intervention group). The intervention group will beyond treatment as usual get a digital communication platform (including an app) where the patient has a good overview of their treatment plan, can report self-monitored health data as daily steps and weight once a week and monitor the daily work with their selected health goal. Everything in the app is individually tailored together with the patient. The patient with digi-physical care will also have assess to a chat for communication with their caregivers. The app has a high degree of authentication and classified as a journal system. Half of yearly treatment as usual sessions will be digital for the intervention group.
The digi-physical method of treatment is developed and based on the desire from the patient association HOBS (hälsa oberoende av storlek). In parts of Sweden people have long distance to the clinic which makes it difficult to be present at the treatment in-clinic sessions and the families loses many hours away from school and work. The null hypothesis is that digi-physical care will have a positive effect on BMI SDS, however inferior to treatment as usual.
In addition to evaluate that this new treatment alternative is safe will also ISO-BMI, weight development and metabolic risk factors be evaluated. The study does not include any extra blood samples or visits to the clinic thus everything is collected according to regular care programs. To evaluate the food intake and possible changes there will be three 24-h recalls, combined with riksmaten flex, performed. There will also be questions about their physical activity and a survey (PEDS-QL) for mental health. For a few volunteered patient families, approximate 15-20, will participate in semi-structured deep interviews.
The digi-physical method of treatment is developed and based on the desire from the patient association HOBS (hälsa oberoende av storlek). In parts of Sweden people have long distance to the clinic which makes it difficult to be present at the treatment in-clinic sessions and the families loses many hours away from school and work. The null hypothesis is that digi-physical care will have a positive effect on BMI SDS, however inferior to treatment as usual.
In addition to evaluate that this new treatment alternative is safe will also ISO-BMI, weight development and metabolic risk factors be evaluated. The study does not include any extra blood samples or visits to the clinic thus everything is collected according to regular care programs. To evaluate the food intake and possible changes there will be three 24-h recalls, combined with riksmaten flex, performed. There will also be questions about their physical activity and a survey (PEDS-QL) for mental health. For a few volunteered patient families, approximate 15-20, will participate in semi-structured deep interviews.
Study Oversight
Has Oversight DMC:
False
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?: