Effectiveness and Mechanisms of Lifestyle Intervention for College Students

Effectiveness and Mechanisms of Lifestyle Intervention for College Students: Competence for Lifestyle Change, Occupational Balance, Perceived Health, and Well-being

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lifestyle, Healthy
• Intervention / Treatment: Behavioral: occupation-based lifestyle intervention; Other: Other courses

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsin-Chun Yeh, MS; Phone Number: 5909 +886-6-2353535; Email: claireyeh21@gmail.com
• Study Contact Backup: Name: Ling-Hui Chang, PhD; Phone Number: 5907 +886-6-2353535; Email: lhchang@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• currently enrolled college students

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lifestyle course; Participants for the experimental group will be recruited from students who enrolled in the lifestyle course in the university during the academic years. Participants in the experimental group engage in the research by providing consent for the analysis of their learning process and by completing questionnaires.	Behavioral: occupation-based lifestyle intervention; 9 week lifestyle course
Active Comparator: other courses; The control group will be recruited from other courses in the same university, during the same academic years. The control group engages in the research by completing questionnaires.	Other: Other courses; Other courses in the same university, during the same academic years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stages of Change Ladder	The Stages of Change Ladder is a self-assessment 'readiness for action' scale, developed by Biener and Abrams in 1991 based on the Transtheoretical Model. It consists of 11 steps, scored from 0 to 10. It assesses the respondent's self-rated readiness to change a specific problem or behavior, with participants choosing which step best represents their current thoughts or behavioral state. A higher score indicates greater readiness. For instance, 0 signifies no intention to change, while 10 indicates active steps are being taken to address the problem, such as inquiring smokers, "Each step represents a smoker's thoughts or actions about quitting. Circle the step that best fits your state." Some steps have descriptive text, such as the bottom step 'not at all ready to change' (0) to the top step 'already starting to act' (10) (Biener & Abrams, 1991). The Stages of Change Ladder demonstrates good construct validity and criterion-related validity (Amodei & Lamb, 2004).	Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
Competence in Health-Promoting Lifestyle Arrangements Questionnaire	This measurement is developed by the research team. Measures attitudes towards, knowledge of, skills in, and self-efficacy in health-promoting lifestyle arrangements. The questionnaire's 11 questions correspond to the learning objectives of the 'Occupation and Health Promotion' course. It uses a 1 to 10 numerical rating scale, with higher scores indicating higher levels of perceived attitude, knowledge, skill mastery, and self-efficacy. This questionnaire was designed in 2021 for this course and established content validity through two rounds of the Delphi method (CVI = .875 ~ 1.000). Questionnaire showed good internal consistency (Cronbach's α = .921) and convergent validity (r = 0.55, df = 143, p<0.001) with Occupational Balance Questionnaire 11-Chinese version (Chen et al., 2022; Yeh & Chang, 2024).	Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occupational Balance Questionnaire 11-Chinese version (OBQ11_C)	Measures occupational balance, i.e., subjectively feeling that life consists of an appropriate amount and variety of occupations. It consists of 11 items, with a total score of 33. Each item is rated on a Likert scale for agreement with the statement: strongly disagree (0), disagree (1), agree (2), strongly agree (3). OBQ11-C has good expert validity (scale-level CVI = .93) and, with a sample of Taiwanese patients with depression, the questionnaire demonstrated good reliability, including internal consistency (Cronbach's α=0.898), test-retest reliability (ICC=0.818), and a four-point scale structure supported by Rasch analysis (Chen et al., 2022).	Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
Self-perceived Health Scale	Refers to past research on self-perceived health, selecting three questions to inquire about overall self-perceived health, health compared to others, and satisfaction with overall health (Chen et al., 2014; Hwang et al., 2018; Chang et al., 2014; Tang et al., 2015; Yeh, 2022; Yao et al., 2002). It uses a 1 to 10 numerical rating scale, with higher scores indicating better perceived health. Based on students who took the course in the 2022, the three questions on self-perceived health demonstrated good internal consistency (Cronbach's α = .913)	Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
Taiwanese Version of the World Health Organization-Five Well-Being Index (WHO-5-TW)	Measures subjective psychological well-being. It consists of five questions asking about the frequency of well-being status in the past two weeks, with higher scores indicating more frequent comfort: never (0), sometimes (1), less than half the time (2), more than half the time (3), most of the time (4), all the time (5). This scale has good clinical validity and is suitable for outcome evaluation (Topp et al., 2015). WHO-5-TW demonstrates good internal consistency (Cronbach's α = .94) (Lin et al., 2013).	Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Collaborators: Ministry of Education, Taiwan
• Investigators: Study Chair: Ling-Hui Chang, PhD, Department of Occupational Therapy, National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Estimated): February 27, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Estimated): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: lifestyle intervention; online; college student
• Other Study ID Numbers: PMN1110332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participants were not requested to consent to the sharing of their data beyond the specific scope of this study. Consequently, in adherence to privacy and confidentiality considerations, we are unable to make their individual data available for external use.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No