Active Young, Healthy Mind. The YoungFitT Project
- Conditions
- University Students
- Interventions
- Behavioral: Mindfulness-Based Stress Reduction Program (MBSR)Behavioral: QigongBehavioral: High-Intensity Functional Training (HIFT)
- Registration Number
- NCT06406283
- Lead Sponsor
- University of Barcelona
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 219
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness Group Mindfulness-Based Stress Reduction Program (MBSR) - Qigong Group Qigong - High-Intensity Functional Training (HIFT) Group High-Intensity Functional Training (HIFT) -
- Primary Outcome Measures
Name Time Method Changes in Executive Function - Flexibility Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Trail Making Test Part B. Seconds to complete the alphanumeric sequence. Direct score. More time indicates worse performance.
Changes in visual attention Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Trail Making Test Part A. Seconds to complete the numerical sequence. Direct score. More time indicates worse performance.
Changes in verbal memory Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Rey Auditory Verbal Learning Test. Direct score. Range 0-75. Higher scores indicate better performance.
Changes in processing speed Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Symbol-Digit Coding subtest from the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III). Direct score. Range 0-133. Higher scores indicate better performance.
Changes in immediate verbal attention Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Direct Digit Span, subtest from the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III). Span. Direct score. Range 0-9. Higher scores indicate better performance.
Changes in Depression, anxiety and stress Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Depression, Anxiety and Stress Scale-21 (DASS-21). Direct score. Range 0-126. Higher scores indicate more global symptoms
Changes in visual memory Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Rey-Osterrieth Complex Figure. The memory drawing accuracy at 3-5 minutes. Direct score. Range 0-36. Higher scores indicate better performance.
Changes in Executive Function - Inhibition Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Stroop Color and Word Test. Interference of the Stroop Color and Word Test. Interference is calculated as follows: CW - ((W \* C) / (W + C)). Higher scores indicate better performance. Negative values are possible, meaning a bad performance.
Changes in Executive Function - Verbal Fluency Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Phonetic Fluency is measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animal. The total number of evoked words starting with the letters P, M, and R (60 seconds for each letter) and animals (60 seconds). Direct score. Higher scores indicate better performance.
Changes in Self-esteem Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Rosenberg Self-esteem scale (RSE). Direct scores from 10 to 40. Higher scores indicate higher self-esteem.
Change in verbal digit working memory Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Backward Digit Span subtest from the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III). Span. Direct score. Range 0-8. Higher scores indicate better performance.
Changes in Verbal Comprehension Baseline (2 weeks before) Vocabulary subtest from the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III). Direct score. Range 0-66. Higher scores indicate better performance.
Changes in Psychological symptoms Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) 90 Symptoms Inventory (90-SCL-R). Direct scores from 0 to 4. Higher scores indicate more symptomatology.
Changes in Mindfulness Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Five facet mindfulness questionnaire (FFMQ). Direct scores from 39 to 195. Higher scores indicate more Mindfulness levels.
Changes in Self-efficacy Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) General self-efficacy scale (GSE). Direct scores from 10 to 40. Higher scores indicate more self-eficacy.
Changes in Sleep quality Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Pittsburgh Sleep Quality Index (PSQI). Direct score. Range 0-21. Lower scores indicate better sleep quality.
Changes in Diet Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Mediterranean Diet Assessment Tool (PREDIMED). Direct score. Range 0-14. Higher scores indicate more adherence to a Mediterranean diet.
- Secondary Outcome Measures
Name Time Method Changes in Anthropometric Measurements - Body Mass Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Body mass index (BMI)
Changes in Anthropometric Measurements - Height Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Height in meters
Changes in Physiological stress - blood pressure Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Blood pressure. Sistolic and diastolic blood pressure in millimeters of mercury.
Changes in lower body muscle power Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Countermovement jump. Initial velocity and power output in countermovement jump in meters per second.
Changes in strength of the hand flexor muscles Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Han-grip test. Right and left hand grip strength in kilogram-force.
Changes in balance Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Y-balance test. Composite score of left leg Y Balance Test (% of leg length) (in cm). Formula = ((YBALANCE_L_ANTERIOR + YBALANCE_L_POSTEROMEDIAL + YBALANCE_L_POSTEROLATERAL) / (3 \* LEG_LENGTH)) \* 100
Microbiota data Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Quantification of different bacterial species from the fresh stool samples
Changes in Anthropometric Measurements - Waist and hip circumference Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Waist and hip circumference. Waist-to-hip ratio.
Changes in Physiological stress - Heart rate variability Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) RMSSD
Changes in brain volumetry Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Grey and white matter volume measured by MRI
Changes in Physical activity Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) International Physical Activity Questionnaire (IPAQ). Total physical activity measured in MET-min/week through the International Physical Activity Questionnaire - Short Form. Direct score. Higher scores indicate more physical activity.
Changes in Anthropometric Measurements - Weight Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Weight in Kg
Changes in aerobic capacity Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Submaximal oxygen consumption test. Estimated VO2 score from submaximal step test.
Changes in flexibility Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Sit-and-reach test. Corrected sit and reach distance in centimeters.
Changes in Resting-state connectivity Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) Resting state brain activity using fMRI
Changes in White matter integrity Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) White matter integrity: tractography
Changes in emotional status Follow-up (2 weeks after completing interventions) Semi-structured interview with qualitative content and sentiment analysis
Usability Virtual Reality System: Follow-up (2 weeks after completing interventions) System Usability Scale (SUS). Direct scores from 0 to 100. Higher scores indicate more usability
Trial Locations
- Locations (1)
Maria Mataro
🇪🇸Barcelona, Spain