AzTrials
AzTrials

HealthyNCT06540898

Impact of Mindful Eating and Movement on University Students' Food and Physical Literacy, and Social-Emotional Competencies

A study testing Mindfulness-Based Eating and Movement Program in people with Healthy, run by University of Macau at 2 sites in Macau.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to investigate if the mindful eating and movement program can improve food literacy, physical literacy, and social-emotional competencies in university students aged 18-25 years. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Mindfulness-Based Eating and Movement Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
2 sitesMacau
Study dates
18 Sep 2024to 31 Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • University undergraduate students aged 18 to 25 years old who are not pregnant;
  • Chinese-speaking adults;
  • Willing to sign the consent form;
  • Willing to attend mindful practice regularly;
  • No prior experience with formal mindfulness practices such as mindful eating or mindful movement.

Who cannot join

  • Not university undergraduate students;
  • Below 18 years old or above 25;
  • Non-Chinese speaking adults;
  • Unable or refuse to sign the consent form;
  • Refuse to attend mindful practice regularly;
  • History of eating disorders;
  • Severe mental health disorders requiring ongoing treatment;
  • Physical conditions limiting participation in physical activities.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

ManCheng LEI, Master contact

+853 66878381

vivianalei71@gmail.com

SiMan LEI, Doctoral contact

alicelei@um.edu.mo

Macau2 sites, 2 recruiting
  • UM Sports Complex (N8) , Avenida da Universidade Taipa, Macau, China

    Macao

    Si Man Lei, 853 88228720, alicelei@umac.mo

    Recruiting
  • University of Macau

    Macao

    Si Man LEI, Doctoral, +853 8822 8720, alicelei@um.edu.mo

    Recruiting

About this study

Official title: The Effects of Mindful Eating and Movement on Food Literacy, Physical Literacy and Social Emotional Competencies Among University Students in Macau

The goal of this clinical trial is to investigate if the mindful eating and movement program can improve food literacy, physical literacy, and social-emotional competencies in university students aged 18-25 years. The main questions it aims to answer are:

  1. Will the mindful eating and movement program lead to significant improvements in food literacy?
  2. Will the mindful eating and movement program enhance physical literacy?
  3. Will the mindful eating and movement program improve social-emotional competencies?
Read more

Researchers will compare an intervention group receiving the combined mindful practices with a control group participating in standard physical education to see if the intervention group shows greater improvements in these areas.

Participants will:

Engage in mindful eating exercises during the break of physical education classes for 10 minutes.

Participate in mindful movement exercises before each physical education class end for 10 minutes, in pairs or in groups.

Complete baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after) assessments to measure changes in food literacy, physical literacy, and social-emotional competencies.

Conditions
Healthy
Being tested
Mindfulness-Based Eating and Movement Program
Keywords
Mindful Eating, Mindful Movement, Food Literacy, Physical Literacy, Social-Emotional Learning, Health Behavior, Nutrition
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-Based Eating and Movement ProgramBehavioural

    This intervention integrates mindful eating practices and mindful movement into physical education classes for a duration of 8 weeks.

    Each session begins with a 10-minute mindful eating practice designed to enhance participants; awareness of hunger and fullness cues, the sensory experience of eating, and their emotional responses to food. The program is to address food literacy, physical literacy, and social-emotional learning. It applied the principles of various established mindfulness and cognitive behavioral therapies and the book "The Joy of Half a Cookie: Using Mindfulness to Lose Weight and End the Struggle with Food" . It is grounded in the components of Mindfulness-Based Eating Awareness Training. The movement practices include basic poses in pairs and groups, and breath awareness techniques to facilitate a mindful connection with physical sensations and mental states.

Study groups in NCT06540898
Study groupRoleWhat they receive
Experimental GroupExperimentalParticipants in this arm engage in an 8-week program that integrates mindful eating and mindful movement practices into their regular physical education classes. Each class includes a 10-minute mindful eating practice focused on enhancing awareness of hunger and fullness cues, sensory experiences of food, and emotional responses to eating. Following this, the final 10 minutes of each class are dedicated to mindful movement exercises, which combine physical postures and movement with mindfulness techniques to promote food literacy, physical literacy and social emotional competencies.
Receives: Behavioral: Mindfulness-Based Eating and Movement Program
Control GroupNo interventionStandard Physical Education Participants in this arm continue with their regular physical education classes as usual, without the integration of any mindfulness practices. This control arm involves the standard activities and curriculum designed for physical education classes at the university, which may include a variety of physical exercises, sports, and theoretical instruction related to health and fitness.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Food Literacy Evaluation Questionnaire (FLEQ-Ch)

    Improvement in food literacy knowledge will be assessed using the Food Literacy Evaluation Questionnaire (FLEQ-Ch). This 15-item questionnaire is structured into three main dimensions: Planning and Management, Selection, and Preparation. It evaluates participants' knowledge related to making informed food choices. Participants respond to each item using a 4-point Likert scale ranging from 0 (Never) to 3 (Always). The total score ranges from 0 to 45, with higher scores indicating higher levels of food literacy.

    Measured: Baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after).

  2. Mindful Eating Questionnaire (MEQ)

    Improvement in mindful eating behaviors will be assessed using the Mindful Eating Questionnaire (MEQ), designed by Framson et al. (2009). This 28-item questionnaire evaluates eating behavior across five subscales: Awareness, Distraction, Disinhibition, Emotional Response, and External Cues. Participants rate a 4-point Likert scale from 1 (never/rarely) to 4 (usually/always). The total MEQ score is calculated as the average of all subscale scores, ranging from 28 to 112. The higher the score, the higher degree of mindful eating behavior.

    Measured: Baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after).

  3. 24-Hour Dietary Intake Records

    Improvement in food literacy will be assessed through 24-hour dietary intake records. This metric evaluates participants' ability to maintain balanced eating habits. The 24-hour dietary intake will be measured each time on the day of the mindfulness session and on the days when participants complete the questionnaires.

    Measured: Baseline, each mindfulness session, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after).

  4. Perceived Physical Literacy Instrument (PPLI)

    Enhancement in physical literacy will be assessed using the Perceived Physical Literacy Instrument (PPLI). This instrument consists of 9 items across three subscales: Knowledge and Understanding, Self-Expression and Communication with Others, and Sense of Self and Self-Confidence. The Knowledge and Understanding subscale evaluates participants' attitudes and awareness of the health benefits of sports. The Self-Expression and Communication with Others subscale evaluates participants' social skills and confidence in natural environments. The Sense of Self and Self-Confidence subscale evaluates participants' physical fitness and self-management skills. The instrument consists of 9 items that are rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The total score for the PPLI ranges from 9 to 45, with higher scores indicating higher levels of perceived physical literacy.

    Measured: Baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after).

  5. International Physical Activity Questionnaire (IPAQ-SF)

    Enhancement in physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ-SF). This metric evaluates the frequency and duration of various physical activities over the past 7 days. It contains of 7 items. The total score for the IPAQ-SF is calculated in Metabolic Equivalent of Task (MET) minutes per week, reflecting the energy expenditure for each type of activity. The minimum score is 0 MET-minutes per week, indicating no physical activity, while there is no fixed maximum score, as it depends on the reported duration and frequency of activities. Higher scores on the IPAQ-SF indicate higher levels of physical activity, reflecting greater energy expenditure.

    Measured: Baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after).

  6. International Fitness Scale (IFIS)

    Enhancement in self-reported fitness elements will be assessed using the International Fitness Scale (IFIS). This metric evaluates participants' general fitness, cardiorespiratory fitness, muscle strength, speed and agility, and flexibility (1 = very poor, 2 = poor, 3 = average, 4 = good, 5 = very good). IFIS consists of 5 items, the total score is the sum of the individual item scores ranging from 5 to 25. Higher scores represent better perceived physical fitness across the different dimensions assessed.

    Measured: Baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after).

  7. Social and Emotional Competencies Questionnaire (SEC-Q)

    Development in social-emotional competencies will be assessed using the Social and Emotional Competencies Questionnaire (SEC-Q), developed by Zych et al. (2018). This 16-item questionnaire measures social-emotional competencies across four dimensions: Self-awareness, Self-management and Motivation, Social Awareness and Prosocial Behavior, and Decision-making. Each item rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is calculated by summing all subscale scores, from 16 to 80. The higher the score, the greater the social and emotional competence.

    Measured: Baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after).

  8. Social Emotional Learning Scale-Young Adult Form (SELS-YF)

    Measured using the Social Emotional Learning Scale-Young Adult Form (SELS-YF), developed by Karacan-Özdemir and Büyükçolpan (2021). This 20-item questionnaire measures the social-emotional learning skills of individuals aged 18-24 across five dimensions based on the Collaborative for Academic, Social, and Emotional Learning (CASEL) model (2003): Self-awareness, Academic self-regulation, Social awareness, Relationship-building skills, and Responsible decision-making skills. Participants rated on a 5-point Likert scale from 1 (never) to 5 (always). Total scores range from 20 to 100, The higher the score, the greater the social-emotional learning skills.

    Measured: Baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after).

Secondary outcomes (2)
  1. Difficulties in Emotion Regulation Scale Short Form (DERS-SF)

    Improvement in emotional regulation will be assessed using the Difficulties in Emotion Regulation Scale Short Form (DERS-SF). This metric evaluates participants' abilities to regulate their emotions effectively. Participants rate each item on a 5-point Likert scale, indicating how often the items apply to them, from 1 (almost never) to 5 (almost always). Each subscale score is computed as the sum of its corresponding items, with the total DERS-SF score calculated by summing all 18 items. This results in a range from 18 to 90, with higher scores indicating greater difficulties in emotion regulation.

    Measured: Baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after).

  2. Perceived Stress Scale (PSS-10)

    Reduction in stress levels will be assessed using the Perceived Stress Scale (PSS-10). This metric evaluates the degree to which participants perceive their lives as unpredictable, uncontrollable, and overloaded. Each question scores from 0 (never) to 4 (very often). Questions 1 to 3 are assessed using a direct scoring method, whereas questions 4 to 8 are evaluated using a reverse scoring method. The total PSS-10 score is calculated by adding up the scores of each item, with individual scores ranging from 0 to 40. Greater scores correspond to greater levels of perceived stress.

    Measured: Baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start18 Sep 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06540898
Sponsor's protocol ID
HE-0138-2024
Status last verified
Sep 2024
First submitted
24 Jul 2024
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Eating and Movement Program in people with Healthy, run by University of Macau at 2 sites in Macau.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Macau. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ManCheng LEI, Master (+853 66878381, vivianalei71@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Food Literacy Evaluation Questionnaire (FLEQ-Ch) (time frame: Baseline, immediately post-intervention (8 weeks), and one month post-intervention (4 weeks after).). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in