Lifestyle, HealthyNCT06239597
Effectiveness and Mechanisms of Lifestyle Intervention for College Students
A study testing occupation-based lifestyle intervention and Other courses in people with Lifestyle, Healthy, run by National Cheng Kung University at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lifestyle, Healthy
- What is being tested?
- occupation-based lifestyle intervention and Other courses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Feb 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- currently enrolled college students
Who cannot join
- students who are unable to complete the questionnaires smoothly due to language barriers with Traditional Chinese.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- Background: College students demonstrate a need for enhanced engagement in health-related lifestyles, including physical activities, nutritional behaviors, and stress management. 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. 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.
- Research purpose:
- 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.
- To explore the mechanisms between the course design and the students' learning.
- 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.
- Research Design: Mixed-method approach was selected. Three phases of the research protocol are as follows:
- 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.
- 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, Lifestyle Redesign, self-management program, and the Transtheoretical Model of Behavioral Change, 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 IBM SPSS 17.0.
- 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.
- Expected contribution:
- 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.
- This research will contribute to the knowledge of concrete, feasible, and effective behavior change intervention targeting young adults, aiming at health promotion.
- 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.
- Conditions
- Lifestyle, Healthy
- Being tested
- occupation-based lifestyle intervention, Other courses
- Keywords
- lifestyle intervention, college student, online
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occupation-based lifestyle interventionBehavioural
9 week lifestyle course
Other coursesOther
Other courses in the same university, during the same academic years.
| Study group | Role | What they receive |
|---|---|---|
| Online lifestyle course | Experimental | 2 hours/session, one session/week, for 9 weeks. Online discussions, reflections, and activities are designed based on the Lifestyle Redesign literature and the health self-management knowledge. Receives: Behavioral: occupation-based lifestyle intervention |
| Control | Active comparator | Ordinary college courses Receives: Other: Other courses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stages of Change Ladder
The Stages of Change Ladder is a self-assessment 'readiness for action' scale, developed based on the Transtheoretical Model of Behavior Change. 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 behaviors are being taken.
Measured: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
Healthy Occupation and Lifestyle Competence Scale (HoLCS)
Measures the willingness for a healthy lifestyle (5 items) and the lifestyle adjustment skills (4 items). Using numerical rating scale scoring from 1 to 10, higher scores indicate higher levels of lifestyle competence. HoLCS demonstrated good content validity, good internal consistency, good convergent validity, and good construct validity based on confirmatory factor analysis.
Measured: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
Secondary outcomes (3)
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.
Measured: 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. 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)
Measured: 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.
Measured: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start27 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- an experimental group and a control group will be applied.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Taiwan
- Responsible party
- Principal investigator, Ling-Hui Chang, National Cheng Kung University
- Investigators
- Ling-Hui Chang, PhD, Study chair, Department of Occupational Therapy, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239597
- Sponsor's protocol ID
- PMN1110332
- Status last verified
- Jun 2025
- First submitted
- 25 Jan 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Mechanisms of Lifestyle Intervention for College Students: Competence for Lifestyle Change, Occupational Balance, Perceived Health, and Well-being
- ClinicalTrials.gov ID
- NCT06239597
- Acronym / sponsor ID
- PMN1110332
- Conditions
- Lifestyle, Healthy
- Keywords
- lifestyle intervention, college student, online
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Collaborators
- Ministry of Education, Taiwan
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Background: College students demonstrate a need for enhanced engagement in health-related lifestyles, including physical activities, nutritional behaviors, and stress management. 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. 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.
- Research purpose:
- 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.
- To explore the mechanisms between the course design and the students' learning.
- 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.
- Research Design: Mixed-method approach was selected. Three phases of the research protocol are as follows:
- 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.
- 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, Lifestyle Redesign, self-management program, and the Transtheoretical Model of Behavioral Change, 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 IBM SPSS 17.0.
- 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.
- Expected contribution:
- 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.
- This research will contribute to the knowledge of concrete, feasible, and effective behavior change intervention targeting young adults, aiming at health promotion.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- an experimental group and a control group will be applied.
| Arm | Type | Receives |
|---|---|---|
| Online lifestyle course | Experimental | Behavioral: occupation-based lifestyle intervention2 hours/session, one session/week, for 9 weeks. Online discussions, reflections, and activities are designed based on the Lifestyle Redesign literature and the health self-management knowledge. |
| Control | Active comparator | Other: Other coursesOrdinary college courses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- currently enrolled college students
Key exclusion criteria (1 listed)
- students who are unable to complete the questionnaires smoothly due to language barriers with Traditional Chinese.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| occupation-based lifestyle intervention9 week lifestyle course | Behavioural | Online lifestyle course |
| Other coursesOther courses in the same university, during the same academic years. | Other | Control |
Primary outcome
Stages of Change Ladder
Time frame: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
The Stages of Change Ladder is a self-assessment 'readiness for action' scale, developed based on the Transtheoretical Model of Behavior Change. 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 behaviors are being taken.
Healthy Occupation and Lifestyle Competence Scale (HoLCS)
Time frame: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
Measures the willingness for a healthy lifestyle (5 items) and the lifestyle adjustment skills (4 items). Using numerical rating scale scoring from 1 to 10, higher scores indicate higher levels of lifestyle competence. HoLCS demonstrated good content validity, good internal consistency, good convergent validity, and good construct validity based on confirmatory factor analysis.
3 secondary outcomes
Occupational Balance Questionnaire 11-Chinese version (OBQ11_C)
Time frame: 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
Time frame: 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)
Time frame: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling-Hui Chang, PhD study chair
Department of Occupational Therapy, National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occupation-based lifestyle intervention and Other courses in people with Lifestyle, Healthy, run by National Cheng Kung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stages of Change Ladder (time frame: Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.