Active Young, Healthy Mind. The YoungFitT Project

University of Barcelona

Status: Enrolling

Conditions: University Students

Treatments: Behavioral: Mindfulness-Based Stress Reduction Program (MBSR); Behavioral: Qigong; Behavioral: High-Intensity Functional Training (HIFT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06406283

PID2022-137776OB-100 (Other Grant/Funding Number)

UB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals aged 18-25 years old
• Fluency in Catalan or Spanish (I.e., able to understand and speak)
• Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki.

Exclusion criteria

• Severe Neurological or psychiatric history
• Alcohol or drug abuse history
• Injury that prevents exercise

Exclusion criteria only for MRI examination:

• Claustrophobia
• Medical device (e.g., pacemaker implants, stents)
• Other metal objects in the body

Exclusion criteria only for VR study:

• Dizziness
• Contraindications or troubles that could condition the use of VR

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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219 participants in 3 patient groups

High-Intensity Functional Training (HIFT) Group

Experimental group

Treatment:

Behavioral: High-Intensity Functional Training (HIFT)

Mindfulness Group

Experimental group

Treatment:

Behavioral: Mindfulness-Based Stress Reduction Program (MBSR)

Qigong Group

Experimental group

Treatment:

Behavioral: Qigong