Effectiveness and Mechanisms of Lifestyle Intervention for College Students

NCT06239597 | Active Not Recruiting

• 1 other identifier: PMN1110332
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Lifestyle, Healthy

Keywords

lifestyle intervention; college student; online

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  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

  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)

  Questionnaires will be administered at pre-test, post-test, follow-up test after 2 months, follow-up test after 6 months.

Study Arms (2)

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.

Behavioral: occupation-based lifestyle intervention

Control

ACTIVE COMPARATOR

Ordinary college courses

Other: Other courses

Interventions

occupation-based lifestyle intervention BEHAVIORAL

9 week lifestyle course

Online lifestyle course

Other courses OTHER

Other courses in the same university, during the same academic years.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently enrolled college students

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng Kung University: lead
• Ministry of Education, Taiwan: collaborator

Study Sites (1)

National Cheng Kung University

Tainan, Taiwan

Location

Study Officials

• Ling-Hui Chang, PhD

  Department of Occupational Therapy, National Cheng Kung University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The intervention providers are not masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: an experimental group and a control group will be applied.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: February 27, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)