NCT07157566

Brief Summary

This research project aims to explore how combining e-health literacy with mindfulness practices can help university students navigate the complex landscape of e-health information and make more informed, healthier choices. Specifically, the study will assess the current levels of e-health literacy, food literacy, and media literacy among university students, and examine how these factors are related to critical thinking, decision-making confidence, and overall well-being. The project will involve a 4-arm design, including: (1) a mindfulness group, (2) an e-health group, (3) a mindfulness + e-health Group, and (4) a Control Group. Participants in the intervention groups will engage in short mindfulness exercises focused on mindful eating and movement during break times and cool-down sessions of their Physical Education (PE) classes. Additionally, digital health content (e.g., videos and articles) will be provided to enhance e-health literacy. This could lead to better-informed, more confident students who are able to make healthier choices in their daily lives, both during their university years and into the future. Study Aim To evaluate the effectiveness of an 8-week intervention delivered during PE classes, comparing the effects of: 1\. Mindfulness Group 2. E-health Group 3. Mindfulness + E-health Group 4. Control Group The intervention will assess changes in students' e-health literacy, food literacy, media literacy, critical thinking, self-compassion and decision-making self-efficacy over time, with assessments at pre-test, post-test, and 4-week follow-up. Study Hypotheses:

  1. 1.Students in the mindfulness group, e-health group, and combined group will show significantly greater improvements in all outcome measures from pre-test to post-test compared to the control group.
  2. 2.The combined group will demonstrate the greatest gains in literacy and cognitive outcomes, due to the additive effect of both interventions.
  3. 3.Improvements will be maintained at the 4-week follow-up, particularly in the combined group.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Sep 2025Jul 2027

First Submitted

Initial submission to the registry

August 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

August 27, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Randomized Controlled TrialHealth literacyMedia literacyFood LiteracyMindfulnessCritical thinkingDecision makinge-health literacy

Outcome Measures

Primary Outcomes (4)

  • eHealth Literacy Scale (eHEALS)

    This scale is designed to assess an individual's perceived comprehensive ability to use information technology to solve health-related problems, which includes skills such as searching for, evaluating, and applying online health information. Based on the e-Health Literacy Model, the scale covers six core competencies: traditional literacy, health literacy, information literacy, scientific literacy, media literacy, and computer literacy. The scale consists of 8 core items, from question 3 to question 10, each rated on a 5-point Likert scale ranging from 1 = strongly disagree to 5 = strongly agree. The total score is calculated only for the core items, with a possible range of 8 to 40 points. The scale demonstrates high internal consistency reliability, with a Cronbach's α of 0.88. The unidimensional structure is stable, with principal component analysis explaining 56% of the variance and factor loadings ranging from 0.60 to 0.84.

    From enrollment to the end of intervention at 8 weeks, and a 4-week follow up

  • Media Health Literacy Scale (MeHLit)

    This scale is designed to assess adults' abilities to interpret health-related information in the media. Its design is based on an integrated framework combining health literacy and media literacy. The final version of the scale consists of 21 items, divided into five dimensions: Goal Appraisal Skills, Content Appraisal Skills, Implied Meaning Appraisal Skills, Visual Comprehension Skills, and Audience Appraisal Skills. Scoring is conducted using a 5-point Likert scale: Never (0 points) to Always (4 points). The total score is the sum of all item scores, ranging from 0 to 84 points. The scale demonstrates excellent content validity, with a Content Validity Index (CVI) of 0.93 and a Content Validity Ratio (CVR) of 0.87. Exploratory Factor Analysis extracted a 5-factor structure that explains 60.25% of the total variance. Confirmatory Factor Analysis indicated a good model fit (RMSEA = 0.051, CFI = 0.93). The overall scale's Cronbach's α is 0.91.

    From enrollment to the end of intervention at 8 weeks, and a 4-week follow up

  • Food Literacy Evaluation Questionnaire (Chinese version, FLEQ-Ch)

    This scale is designed to assess the food literacy of Chinese residents. The questionnaire was adapted from the original FLEQ (Food Literacy Evaluation Questionnaire) and consists of 15 items divided into three main dimensions: Planning and Management, Selection, and Preparation. The "Planning and Management" dimension includes 7 items evaluating participants' ability to plan meals in advance, create shopping lists, include all food groups in meals, consider healthy choices, manage funds for purchasing healthy foods, and learn ways to access healthy foods. Scoring ranges from 0 (Never) to 3 (Always). The total score ranges from 0 to 45, with higher scores indicating higher levels of food literacy. The FLEQ-Ch demonstrates good psychometric properties, with internal consistency ranging from 0.869 to 0.955 and test-retest reliability coefficients ranging from 0.941 to 0.952.

    From enrollment to the end of intervention at 8 weeks, and a 4-week follow up

  • Assessment Tools for Critical Thinking and Decision-Making Abilities

    The tasks used in this study to assess critical thinking and decision-making abilities were executed using E-Prime 3.0 software (Psychology Software Tools, Inc.) for stimulus presentation and response data collection. E-Prime is widely used in psychological and behavioral research, with its key advantage being the ability to control the presentation timing and duration of visual and auditory stimuli with millisecond precision, while simultaneously recording participants' response times and accuracy rates. It shows potential for application in measuring critical thinking and decision-making abilities in the health domain. These two abilities are crucial for effective personal health management. Although E-Prime is not specifically designed to measure critical thinking and decision-making skills, its functionality is more oriented toward executing experimental tasks. It can indirectly assess cognitive processes related to these abilities.

    From enrollment to the end of intervention at 8 weeks, and a 4-week follow up

Secondary Outcomes (7)

  • New Media Literacy Scale (NMLS)

    From enrollment to the end of intervention at 8 weeks, and a 4-week follow up

  • Self-compassion short form (SCS-SF)

    From enrollment to the end of intervention at 8 weeks, and a 4-week follow up

  • Decision Self-Efficacy Scale

    From enrollment to the end of intervention at 8 weeks, and a 4-week follow up

  • Decisional Conflict Scale

    From enrollment to the end of intervention at 8 weeks, and a 4-week follow up

  • Five Facet Mindfulness Questionnaire (FFMQ-C-SF)

    From enrollment to the end of intervention at 8 weeks, and a 4-week follow up

  • +2 more secondary outcomes

Study Arms (4)

Mindfulness Group

EXPERIMENTAL

Participants in this group will engage in an 8-week program integrating mindful eating and mindful movement practices into their regular physical education classes. Each session includes 10 minutes of mindful eating exercises designed to enhance awareness of hunger and satiety cues, sensory experiences of food, and emotional responses to eating. The final 10 minutes of each session consist of mindful movement exercises, combining physical postures and movements with mindfulness techniques to improve food literacy, physical literacy, and social-emotional competencies.

Behavioral: Mindfulness

E-health Group

EXPERIMENTAL

Participants in this group will receive two digital health information materials per week via Moodle or email, each requiring approximately 5-10 minutes of reading time. The topics of the materials include: health literacy; nutrition; exercise and stress; mental health and sleep; and behavior change and integration. These aim to enhance participants' digital health literacy, media literacy, and related competencies.

Behavioral: e-Health Literacy

Mindfulness + E-health Group

EXPERIMENTAL

Participants in this group will engage in an 8-week program that integrates mindful eating and mindful movement practices into their regular physical education classes, while also receiving digital health information materials to enhance their e-health literacy. The program is designed to improve participants' food literacy, physical literacy, social-emotional competencies, e-health literacy, and media literacy through a combination of practical exercises and educational content.

Behavioral: MindfulnessBehavioral: e-Health Literacy

Control Group

NO INTERVENTION

Participants in this group will follow their regular physical education classes without incorporating any mindfulness practices or digital health information materials. The control group will engage in standard activities and curricula designed for university physical education, which may include various physical training, sports, and theoretical instruction related to health and fitness.

Interventions

MindfulnessBEHAVIORAL

Structured over 8 weeks (twice weekly) with dual modules (dietary + movement), this group employs Mindfulness-Based Eating Awareness Training (MB-EAT) to improve mind-body awareness. Week 1 establishes foundational practices through mindful eating concepts and introductory yoga; Weeks 2-4 systematically train awareness of hunger/satiety cues using partner breathing techniques, postural alignment, and group-assisted stretching; Week 5 analyzes emotional eating triggers while integrating therapeutic yoga for emotional regulation; Weeks 6-7 foster body acceptance and autonomous food choices; the program concludes with closing rituals. Rooted in Mindfulness-Based Stress Reduction (MBSR), it strengthens interoceptive awareness, non-judgmental self-acceptance, and emotional management to transform dysfunctional eating patterns.

Mindfulness + E-health GroupMindfulness Group

This 8-week program (twice weekly) aims to enhance participants' ability to access, evaluate, and apply digital health information. It progresses through sequential modules: Week 1 introduces e-Health literacy fundamentals and physical activity principles; Weeks 2-3 focus on nutritional assessment and personalized planning; Week 4 addresses sleep health; Weeks 5-7 train health information retrieval skills, including database navigation and source reliability verification; the final week hones critical appraisal capabilities. The intervention is based on the e-Health Literacy 3.0 model and cultivates three core competencies: digital navigation, information discernment, and evidence-based decision-making, enabling participants to independently navigate the digital health ecosystem.

E-health GroupMindfulness + E-health Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Mindfulness Group
  • Currently enrolled in a Physical Education (PE) class.
  • Aged between 18 and 25 years.
  • Willing to participate in the 8-week intervention and provide informed consent.
  • Generally healthy and able to engage in physical activity.
  • Proficient in Chinese.
  • E-health Group
  • Currently enrolled in a Physical Education (PE) class.
  • Aged between 18 and 25 years.
  • Willing to participate in the 8-week intervention and provide informed consent.
  • Generally healthy and able to engage in physical activity.
  • Proficient in Chinese.
  • Mindfulness + E-health Group
  • Currently enrolled in a Physical Education (PE) class.
  • Aged between 18 and 25 years.
  • +9 more criteria

You may not qualify if:

  • Mindfulness Group
  • Currently studying in medical, nutrition, or health-related fields.
  • Pregnant or lactating.
  • Severe mental health conditions or cognitive impairments affecting participation.
  • Currently participating in other mindfulness or digital health programs.
  • Involved in competitive sports (e.g., varsity athletes).
  • Recent major life events (e.g., trauma or major illness) within the last 6 months.
  • Unable to participate in PE classes due to medical or personal reasons.
  • E-health Group
  • Currently studying in medical, nutrition, or health-related fields.
  • Pregnant or lactating.
  • Severe mental health conditions or cognitive impairments affecting participation.
  • Currently participating in other mindfulness or digital health programs.
  • Involved in competitive sports (e.g., varsity athletes).
  • Recent major life events (e.g., trauma or major illness) within the last 6 months.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UM Sports Complex (N8) , Avenida da Universidade Taipa, Macau, China

Macao, Macau

RECRUITING

University of Macau

Macao, Macau

RECRUITING

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • SiMan LEI, Doctoral

    University of Macau

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Long Choi, Master Student

CONTACT

SiMan LEI, Doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 5, 2025

Study Start

September 20, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations