Clinical trial NCT06239597: Effectiveness and Mechanisms of Lifestyle Intervention for College Students
Official title: Effectiveness and Mechanisms of Lifestyle Intervention for College Students: Competence for Lifestyle Change, Occupational Balance, Perceived Health, and Well-being
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lifestyle, Healthy
Keywords: lifestyle intervention
college student
online
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Taiwan
First posted: 2024-02-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: an experimental group and a control group will be applied.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* currently enrolled college students

Exclusion Criteria:

* students who are unable to complete the questionnaires smoothly due to language barriers with Traditional Chinese.

Primary outcomes:
measure: Stages of Change Ladder
timeFrame: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
measure: Competence in Health-Promoting Lifestyle Arrangements Questionnaire
timeFrame: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
Secondary outcomes:
measure: Occupational Balance Questionnaire 11-Chinese version (OBQ11_C)
timeFrame: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
measure: Self-perceived Health Scale
timeFrame: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
measure: Taiwanese Version of the World Health Organization-Five Well-Being Index (WHO-5-TW)
timeFrame: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Occupational Therapy, National Cheng Kung University
name: Ling-Hui Chang, PhD
role: STUDY_CHAIR
References: