- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07280078
Yoga, Meditation and Mindful Eating Intervention in University Students (Yoga-UDEA)
Evaluation of a Yoga, Meditation and Mindful Eating Intervention for the Control of Stress, Anxiety, Depression, and Mindfulness in University Students
The aim of this study is to learn whether a program that combines yoga, meditation, and mindful eating can help reduce stress, anxiety, and depression, and improve mindfulness in university students.
The main questions the study aims to answer are:
- Does participating in yoga, meditation, and mindful eating sessions lower students' levels of stress, anxiety, and depression?
- Does the program improve students' mindfulness and general well-being?
What will happen in the study:
Participants will:
- Attend weekly sessions of yoga, meditation, and mindful eating for 32 hours total.
- Practice physical postures (Asanas), breathing exercises (Pranayama), relaxation, and meditation.
- Receive short lessons about mindful nutrition and healthy lifestyle habits.
- Complete questionnaires before and after the program to measure stress, anxiety, depression, and mindfulness.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Javier M Ceballos Rrueda, PhD
- Phone Number: +57 3174268448
- Email: javier.ceballos@udea.edu.co
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergraduate students enrolled in the curso "Yoga, Meditation, and Mindful Eating" at the Faculty of Pharmaceutical and Food Sciences (CIFAL), University of Antioquia.
- Willing to participate voluntarily and complete all study assessments.
- Able to attend the full program (32 hours over one academic semester).
Exclusion Criteria:
- Students currently practicing yoga or meditation regularly.
- Pregnant women or participants with any medical condition that prevents safe participation in yoga practice.
- Individuals with severe psychiatric disorders requiring pharmacological treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Yoga and Meditation Gruop
University students enrolled in the course "Yoga, Meditation, and Mindful Eating" will participate in a 32-hour holistic intervention.
The program integrates theoretical and practical sessions focused on yoga postures (asanas), breathing exercises (pranayamas), meditation, relaxation, and mindful eating practices based on Ayurvedic principles.
|
The behavioral intervention combines weekly 2-hour sessions for 16-weeks.
Each class includes warm-up exercises, yoga postures for balance and flexibility, breathing techniques (pranayamas), guided meditation, and relaxation.
Additionally, participants receive recommendations on healthy habits, conscious nutrition, and physical well-being.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in academic stress levels measured by the Academic Stress Scale
Time Frame: Baseline (Week 1, pre-test) and Week 16 (post-intervention).
|
Academic stress will be assessed using the Academic Stress Scale, a 54-item self-report questionnaire that evaluates methodological, social, and emotional stressors related to academic activities. Each item is scored on a Likert-type scale. Total scores range from 54 to 270, with higher scores indicating higher levels of perceived academic stress. |
Baseline (Week 1, pre-test) and Week 16 (post-intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in anxiety levels measured by the State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline (Week 1, pre-test) and Week 16 (post-intervention).
|
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), a 40-item self-report instrument consisting of two subscales: State Anxiety (20 items) and Trait Anxiety (20 items). Each subscale score ranges from 20 to 80, with higher scores indicating greater anxiety levels. |
Baseline (Week 1, pre-test) and Week 16 (post-intervention).
|
|
Change in depressive symptoms measured by the Beck Depression Inventory-II (BDI-II)
Time Frame: Baseline (Week 1, pre-test) and Week 16 (post-intervention).
|
Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire. Each item is scored from 0 to 3. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms. |
Baseline (Week 1, pre-test) and Week 16 (post-intervention).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Behavioral Symptoms
- Behavior
- Anxiety Disorders
- Depression
- Stress, Psychological
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Relaxation Therapy
- Yoga
- Meditation
Other Study ID Numbers
- Acta Nº 254 CEI-FE (UDEA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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