Active Young, Healthy Mind. The YoungFitT Project — YoungFitT  

University Students Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 1:1:1 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 (n=58). 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 (n=15). 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. ;

Related Conditions & MeSH terms

• University Students

• NCT number: NCT06406283
• Study type: Interventional
• Source: University of Barcelona
• Contact: Maria Mataró, PhD
• Phone: +34933125052
• Email: mmataro@ub.edu
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Completion date: September 18, 2026