Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
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. 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. The combined group will demonstrate the greatest gains in literacy and cognitive outcomes, due to the additive effect of both interventions.
3. Improvements will be maintained at the 4-week follow-up, particularly in the combined group.
Detailed Description:
This study aims to explore the effects of mindfulness practice and e-health interventions on e-health literacy, media literacy, food literacy, critical thinking, and decision-making abilities among university students.
Research Objectives: To investigate the impact of mindfulness practice and e-health interventions on university students' e-health literacy, media literacy, food literacy, critical thinking, and decision-making abilities, and to evaluate their short-term effectiveness.
Participants: 268 university students aged between 18 and 25 who are willing to participate in mindfulness activities during and after class and receive e-health-related information.
Study Procedure:
1. Baseline Assessment: Includes questionnaires on e-health literacy, media literacy, critical thinking, and food literacy, as well as tests conducted using E-Prime software.
2. Intervention: Participants will take part in an 8-week program during their physical education classes and leisure time. They will be randomly assigned to one of four groups:
Mindfulness Group: Engage in mindful eating and mindful movement exercises during each physical education class (approximately 20 minutes).
E-health Group: Read or listen to two push notifications of e-health information per week, covering topics such as health management, stress and sleep, nutrition, and behavior change.
Combined Group: Participate in both mindfulness practice and receive e-health information.
Control Group: Receive no additional intervention and participate only in regular physical education classes.
3. Post-Intervention Assessment: Immediately after the 8-week intervention, participants will complete the same questionnaires and E-Prime tests as at baseline to assess immediate effects.
4. Follow-Up Assessment: Four weeks after the intervention ends, the same set of measurements will be conducted again to evaluate the sustainability of the intervention effects.
5. Interviews (Optional): With your consent, semi-structured or unstructured interviews may be conducted during and after the intervention to gain in-depth insights into your experiences and perceptions.
Statistical Analysis: A mixed-design analysis of variance (ANOVA) or analysis of covariance (ANCOVA) will be used to compare the effects across different time points. Post-hoc tests will be conducted to identify specific differences between the various groups and across different time points. The significance level will be set at a p-value of less than 0.05.
Study:
NCT07157566
Study Brief:
Protocol Section:
NCT07157566