NCT06540898

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable healthy

Timeline
40mo left

Started Sep 2024

Longer than P75 for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Progress33%
Sep 2024Aug 2029

First Submitted

Initial submission to the registry

July 24, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 18, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

May 15, 2025

Status Verified

September 1, 2024

Enrollment Period

2.3 years

First QC Date

July 24, 2024

Last Update Submit

May 12, 2025

Conditions

Keywords

Mindful EatingMindful MovementFood LiteracyPhysical LiteracySocial-Emotional LearningHealth BehaviorNutrition

Outcome Measures

Primary Outcomes (8)

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

Secondary Outcomes (2)

  • Difficulties in Emotion Regulation Scale Short Form (DERS-SF)

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

  • Perceived Stress Scale (PSS-10)

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants 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.

Behavioral: Mindfulness-Based Eating and Movement Program

Control Group

NO INTERVENTION

Standard 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.

Interventions

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.

Experimental Group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • SiMan LEI, Doctoral

    University of Macau

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ManCheng LEI, Master

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

July 24, 2024

First Posted

August 6, 2024

Study Start

September 18, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 31, 2029

Last Updated

May 15, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations