Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406283
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-10
Brief Title:
Active Young Healthy Mind The YoungFitT Project
Sponsor:
University of Barcelona
Organization:
University of Barcelona
Study Overview
Official Title:
Active Young Healthy Mind Strategies for Brain Health and Psychological Well-being in Young Adults A Randomized Mixed-method Study With and Without Virtual Reality VR YoungFitT Young Fitness Technology
Status:
RECRUITING
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:
YoungFitT
Brief Summary:
The main objective of YoungFitT Project is to study the effect and neuro-psycho-biological mechanisms of mind and body interventions also in the form of virtual reality VR on brain health cognitive and psychological well-being of college students The investigators have adopted an inter and multidisciplinary and multimodal approach to provide a more integrative perspective using cognitive psychological biochemical and neuroimaging measurements The investigators hypothesize that all three interventions Mindfulness-Based Stress Reduction MBSR Qigong and High-Intensity Functional Training HIFT will produce gains in cognitive functions and psychological well-being at three months compared to baseline Also all three interventions will induce changes in the microbiota and brain structure and function Finally using a VR environment for these interventions will provide greater adherence and cognitive and psychological well-being benefits than conventional training
Detailed Description:
The YoungFitT Project is a multicentric prospective parallel single-blinded three-arm mixed-method randomized clinical trial with a sample of 219 participants All of participants are university students aged 18 to 25 years old and will be randomized through a computer-generated allocation sequence with a 111 ratio and stratified by sex
The YoungFitT Project is divided into two Studies
Study 1 Online-based mind and body interventions A total of 174 eligible university students will be randomized into three groups of HIFT Qigong and MBSR n58 All interventions last 12 weeks
Study 2 VR-based mind and body interventions A total of 45 eligible university students will be randomized into three groups of HIFT-VR Qigong-VR and MBSR-VR n15 All interventions last 12 weeks
In both within two weeks before and after the interventions medical cognitive and physical assessments will be performed Neuroimaging and biological samples will be collected in Study 1 only There will be a follow-up 12 weeks after the end of the trials This follow-up will assess online questionnaires about physical and psychological well-being
The objectives of this project are
To evaluate the effectiveness of HIFT Qigong and MBSR interventions on the cognitive and psychological well-being of college students
To study the intervention-induced changes in the microbiome and brain structure and function volume of gray and white matter microstructural integrity functional connectivity and their potential mediator effect on cognitive and psychological well-being outcomes
To study the intervention-induced changes in the physical physical activity and fitness status mental mindful thinking sleep quality and fatigue and physiological stress HRV components and their potential mediator effect on cognitive and psychological well-being outcomes
To determine the potential moderator effects of demographic sex age and educational level and individual factors cognitive reserve general intelligence with intervention-induced changes in cognitive and psychological well-being outcomes
In addition the Study 2 also has these objectives
To generate the virtual environment of the designed interventions HIFT-VR Qigong-VR and MBSR-VR
To evaluate the usability acceptability and outcomes of the newly developed VR interventions in relation to cognitive and emotional health to explore the feasibility of each VR intervention
To study the intervention-induced changes in the physical physical activity and fitness status mental mindful thinking and sleep quality and physiological stress HRV components and their potential mediator effect
To compare effects and adherences of traditional versus VR-based interventions
The YoungFitT Project is divided into two Studies
Study 1 Online-based mind and body interventions A total of 174 eligible university students will be randomized into three groups of HIFT Qigong and MBSR n58 All interventions last 12 weeks
Study 2 VR-based mind and body interventions A total of 45 eligible university students will be randomized into three groups of HIFT-VR Qigong-VR and MBSR-VR n15 All interventions last 12 weeks
In both within two weeks before and after the interventions medical cognitive and physical assessments will be performed Neuroimaging and biological samples will be collected in Study 1 only There will be a follow-up 12 weeks after the end of the trials This follow-up will assess online questionnaires about physical and psychological well-being
The objectives of this project are
To evaluate the effectiveness of HIFT Qigong and MBSR interventions on the cognitive and psychological well-being of college students
To study the intervention-induced changes in the microbiome and brain structure and function volume of gray and white matter microstructural integrity functional connectivity and their potential mediator effect on cognitive and psychological well-being outcomes
To study the intervention-induced changes in the physical physical activity and fitness status mental mindful thinking sleep quality and fatigue and physiological stress HRV components and their potential mediator effect on cognitive and psychological well-being outcomes
To determine the potential moderator effects of demographic sex age and educational level and individual factors cognitive reserve general intelligence with intervention-induced changes in cognitive and psychological well-being outcomes
In addition the Study 2 also has these objectives
To generate the virtual environment of the designed interventions HIFT-VR Qigong-VR and MBSR-VR
To evaluate the usability acceptability and outcomes of the newly developed VR interventions in relation to cognitive and emotional health to explore the feasibility of each VR intervention
To study the intervention-induced changes in the physical physical activity and fitness status mental mindful thinking and sleep quality and physiological stress HRV components and their potential mediator effect
To compare effects and adherences of traditional versus VR-based interventions
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PID2022-137776OB-100 | OTHER_GRANT | Ministerio de Ciencia e Innovación Gobierno de España | None |