Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06239597 |
| Other study ID # |
PMN1110332 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 27, 2024 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
National Cheng Kung University |
| Contact |
Hsin-Chun Yeh, MS |
| Phone |
+886-6-2353535 |
| Email |
claireyeh21[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this trial is to test the effectiveness and learn about the mechanisms and
effectiveness of lifestyle intervention for college students. The main questions it aims to
answer are:
- Is the lifestyle course for college students effective in improving the skills and
confidence for changing lifestyle, occupational balance, perceived health, as well as
well-being for college students?
- What are the mechanisms between the course design and the students' learning?
Participants will join a 9-week online course that aims to facilitate college students to
create health-promoting and satisfying habits and routines. Potentially a mixed format of
online and in-person course design will be applied, depending on the university requirements
and student feedback. Researchers will compare the experimental group and control group to
see if the lifestyle tele-course improves college students' skills and confidence for
changing lifestyle, occupational balance, perceived health, as well as well-being.
Description:
1. Background:
College students demonstrate a need for enhanced engagement in health-related
lifestyles, including physical activities, nutritional behaviors, and stress management
(Ho et al., 2021; Tang et al., 2015). In addition, past surveys reported that college
students are frequently faced with adjustment problems in time management, a propensity
for oversleeping, irregular sleep patterns, lack of life focus, ineffective study
habits, academic stress, lack of motivation for studying, poor physical stamina, and
easily experience fatigue in their functional arrangements (Ting, 2019). These
lifestyle-related challenges can compromise health and quality of life. Although many
college students have tried hard to "make changes" to their daily life, only some of
them smoothly make the change.
Our pilot study found that "Occupation and Health Promotion," a practice-oriented 8-week
lifestyle course delivered by distance learning, could promote college students' skills
and confidence for lifestyle change, occupational balance, and perceived-health.
However, we also observed that the students did not consistently make behavioral changes
in different lifestyle topics. Besides, some topics were perceived as more helpful,
while others were not. Therefore, this study uses a systematic approach to explore the
process of behavioral changes or no-changes, in order to look into the mechanism between
the course design and the facilitated behavioral changes. In addition, the effectiveness
shown in the pilot studies is expected to be replicated in this study.
2. Research purpose:
1. To examine the effectiveness of the lifestyle course for college students, in terms
of the skills and confidence for changing lifestyle, occupational balance,
perceived health and well-being.
2. To explore the mechanisms between the course design and the students' learning.
3. Research hypothesis:
Intervention group will demonstrate greater efficacy in skills and confidence for
changing lifestyle, occupational balance, perceived health and well-being compared to
the control group.
4. Research Design:
Mixed-method approach was selected. Three phases of the research protocol are as
follows:
1. Phase 1: Optimization of the course The optimization of the course will be grounded
upon the detailed observations and documents of the course in the pilot studies,
focus group of the participating students, one-on-one interview of college
students, and expert reviews. Narrative analysis will be used to explore the
process of behavioral changes, and the results will be triangulated with the
Transtheoretical Model of Behavioral Changes, in order to improve the course
design, such as effective teaching strategies and weekly teaching protocols.
2. Phase 2: Effectiveness of the course The effectiveness of the course will be
examined by non-randomized design with an experimental group and a control group.
Questionnaires will be administered at pre-test, post-test, follow-up test after 2
months, follow-up test after 6 months. Sample size was calculated with G*Power
3.1.9.7. Attrition rate is estimated to be 87.5% at the second follow-up test.
Consequently, 100 participants will be recruited in each group.
The experimental group's intervention is an online course, potentially a mixed
format of online and in-person, depending on the university requirements and
student feedback; the control group participates in other university courses. The
course of the experimental group consists of 100-minute weekly sessions for a total
of nine weeks. The course is tailored to bolster students' ability to modify their
lifestyles, thereby enriching their university experience with greater satisfaction
and health. The course design is grounded in Experiential Learning (Kolb et al.,
2001; Kurt, 2020/12/28), Lifestyle Redesign (Clark et al., 2015; Pyatak et al.,
2022), self-management program (Lorig & Holman, 2013), and the Transtheoretical
Model of Behavioral Change (Prochaska, 2020), ensuring a comprehensive and
practical learning experience.
Self-rated online questionnaires will be used to assess motivation to behavioral
changes, knowledge, attitude, skills, and self-efficacy for lifestyle change,
occupational balance, health, as well as well-being. Descriptive analysis and
two-way repeated-measures ANOVA will be conducted with Jamovi 2.3.26(R Core Team,
2021; The jamovi project, 2022).
3. Phase 3: Mechanisms of change Qualitative narrative analysis of the class
materials, including group discussion records, self-reflection papers, and final
reports, will be used to explore the mechanisms between the teaching strategies and
the facilitated behavioral changes.
5. Expected contribution:
1. This research will develop a distance lifestyle intervention approach which is
effective in facilitating college students to gain competence in making lifestyle
change, adopting a healthy lifestyle, as well as improving health and well-being.
2. This research will contribute to the knowledge of concrete, feasible, and effective
behavior change intervention targeting young adults, aiming at health promotion.
3. Distance learning lifestyle courses can transcend spatial limitations, thereby
enhancing student motivation to participate. Practical and executable lifestyle
online courses will facilitate future health promotion for college students.
