Active Young, Healthy Mind. The YoungFitT Project

NCT ID: NCT06406283

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2026-09-18

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 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.

Conditions

University Students

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High-Intensity Functional Training (HIFT) Group

Group Type: EXPERIMENTAL

High-Intensity Functional Training (HIFT)

Intervention Type: BEHAVIORAL

This intervention will include three sessions per week: two group 60-minute zoom online synchronous sessions guided by experts and one individual autonomous session (a repetition of a chosen session of that week).

The training protocol will be designed based on Cross-Training workouts, emphasizing high-intensity interval training combined with functional resistance-training movements.

Mindfulness Group

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction Program (MBSR)

Intervention Type: BEHAVIORAL

This intervention follows the official MBSR program designed by Jon Kabat-Zinn with some adaptations, as we did in Bermudo-Gallaguet, et al. (2022). The intervention will occur three days a week, including one 120-minute online synchronous session and two 20-40 min individual practices. The intensity of physical exercise will be adjusted to personal baseline characteristics.

Qigong Group

Group Type: EXPERIMENTAL

Qigong

Intervention Type: BEHAVIORAL

This intervention will include three sessions per week: two group 60-minute zoom online synchronous sessions guided by experts and one individual autonomous session (a repetition of a chosen session of that week).

The program includes the Baduanjin sequence, considered one of the most ancient and beneficial forms for physical and mental health within the Qigong tradition.

Interventions

High-Intensity Functional Training (HIFT)

This intervention will include three sessions per week: two group 60-minute zoom online synchronous sessions guided by experts and one individual autonomous session (a repetition of a chosen session of that week).

The training protocol will be designed based on Cross-Training workouts, emphasizing high-intensity interval training combined with functional resistance-training movements.

Intervention Type: BEHAVIORAL

Mindfulness-Based Stress Reduction Program (MBSR)

This intervention follows the official MBSR program designed by Jon Kabat-Zinn with some adaptations, as we did in Bermudo-Gallaguet, et al. (2022). The intervention will occur three days a week, including one 120-minute online synchronous session and two 20-40 min individual practices. The intensity of physical exercise will be adjusted to personal baseline characteristics.

Intervention Type: BEHAVIORAL

Qigong

This intervention will include three sessions per week: two group 60-minute zoom online synchronous sessions guided by experts and one individual autonomous session (a repetition of a chosen session of that week).

The program includes the Baduanjin sequence, considered one of the most ancient and beneficial forms for physical and mental health within the Qigong tradition.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ramon Llull

OTHER

Sponsor Role: collaborator

ICREA Academia

UNKNOWN

Sponsor Role: collaborator

Institut de Neurociències de la Universitat de Barcelona

UNKNOWN

Sponsor Role: collaborator

Institut de Recerca Sant Joan de Déu (CERCA center)

UNKNOWN

Sponsor Role: collaborator

EventLab

UNKNOWN

Sponsor Role: collaborator

INEFC

UNKNOWN

Sponsor Role: collaborator

Nirakara Lab

INDUSTRY

Sponsor Role: collaborator

Adventhealth Research Institute, Neuroscience

UNKNOWN

Sponsor Role: collaborator

University of Murdock

UNKNOWN

Sponsor Role: collaborator

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Maria Mataro Serrat

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Mataró, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Locations

Maria Mataro

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Maria Mataró, PhD

Role: CONTACT

mmataro@ub.edu

+34933125052

Samira Rostami, PhD

Role: CONTACT

Samira7rostami@gmail.com

Facility Contacts

Maria Mataro, PhD

Role: primary

mmataro@ub.edu

+34933125052

References

Rostami S, Bermudo-Gallaguet A, Camins-Vila N, Ferrer-Uris B, Busquets A, Ribera M, Coll L, Gallego Vila J, Oliva Martinez R, Slater M, Garcia Diez G, Perales Castellanos N, Larrosa M, Bielsa-Pascual J, Toran-Montserrat P, Bruna Rabassa O, Guerra-Balic M, Erickson KI, Brown B, Serrat MM. The YoungFitT project: Study protocol for a randomized mixed-methods trial of physical exercise and mind-body interventions, with or without virtual reality, in university students. PLoS One. 2025 Aug 1;20(8):e0328538. doi: 10.1371/journal.pone.0328538. eCollection 2025.

Reference Type: DERIVED

PMID: 40748900 (View on PubMed)

Other Identifiers

PID2022-137776OB-100

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UB

Identifier Type: -

Identifier Source: org_study_id