Influence of Lifestyle Modification Program on Meaningful Participation and Quality of Life of Independent Taiwanese Older Adults

NCT06447883 | Completed

• 1 other identifier: KMUHIRB-E(I)-20170158
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the differences between health-related quality of life and meaningful participation among two groups. The main question it aimed to answer are: whether the older adults from experimental group who received 24-week lifestyle modification program would have higher level of health-related quality of life and meaningful participation compared to those who did not receive the program from the control group. Participants in experimental group had to attend in a 24-week lifestyle modification program. Researchers will compare the experimental and control group to see if there were differences between their health-related quality of life and meaningful participation.

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (3)

• SF-36 Taiwan version

  Health-related quality of life (QoL) was measured by the SF-36 Taiwan version, a, standardized, self-report questionnaire commonly used to determine the effect of medical and community-based health intervention. Comprising 36 questions, it gauges self-perceived physical health and mental well-being over the past four weeks across eight domains: Physical Functioning, Role Limitations due to Physical Health Problems (Role-Physical), Bodily Pain, General Health, Vitality, Social Functioning, Role Limitations due to Emotional Problems (Role-Emotional), and Mental Health. Responses within each domain were summed and transformed, generating dimension scores ranging from 0 (poor health) to 100 (good health). The experimental and control groups completed the measurement pre-intervention and immediately after the experimental group received the intervention.

  pre-intervention and immediately after the intervention

• Taiwanese version of the Meaningful Activity Participation Assessment

  This study assessed the frequency and degree of meaningful participation using the Taiwanese version of the Meaningful Activity Participation Assessment (T-MAPA). This 25-item tool, yields scores ranging from 0 to 300, with higher scores denoting increased meaningful participation over the past three months. Culturally adapted to Taiwan, the T-MAPA has demonstrated robust reliability and validity.The experimental and control groups completed the measurement pre-intervention and immediately after the experimental group received the intervention.

  pre-intervention and immediately after the intervention

• Individual semi-structured interviews

  Individual semi-structured interviews were conducted with participants in the experimental group at three stages during the study, including pre-intervention, during the intervention, and immediately after the intervention, each lasting 30 to 90 minutes.

  pre-intervention, during the intervention, and immediately after the intervention

Study Arms (2)

Lifestyle modification program

EXPERIMENTAL

The LMP included 12 treatment modules which was administered by the occupational therapist with a national occupational therapist license and a certification from the USC Lifestyle Redesign® course in 2001. The experimental group engaged in 24 weekly group sessions, each lasting approximately 2 hours. Each session started with stretching, followed by knowledge sharing, group discussion, and activities participation which aligned with the session's themes and discussion topics. The four strategies, including didactic presentation, peer exchange, direct experience, and personal exploration, were employed to deliver the treatment module content. Following these strategies, the primary researcher emphasized the connection between participants' personal meanings, individual contexts, and occupations. Afterward, participants were encouraged to formulate a personalized action plan and integrate what they had learnt into their daily routine.

Behavioral: Lifestyle modification program

Control group

NO INTERVENTION

The control group participants were selected from the same community as the experimental group but did not receive the LMP.

Interventions

Lifestyle modification program BEHAVIORAL

The LMP included 12 treatment modules which was administered by the occupational therapist with a national occupational therapist license and a certification from the USC Lifestyle Redesign® course in 2001. The experimental group engaged in 24 weekly group sessions, each lasting approximately 2 hours. Each session started with stretching, followed by knowledge sharing, group discussion, and activities participation which aligned with the session's themes and discussion topics. The four strategies, including didactic presentation, peer exchange, direct experience, and personal exploration, were employed to deliver the treatment module content. Following these strategies, the primary researcher emphasized the connection between participants' personal meanings, individual contexts, and occupations. Afterward, participants were encouraged to formulate a personalized action plan and integrate what they had learnt into their daily routine.

Lifestyle modification program

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 55 years old
• independently community-dwelling
• proficient in Mandarin Chinese or Taiwanese

You may not qualify if:

• show overt signs of psychosis or dementia

Sponsors & Collaborators

• Hui-Jen Shyu: lead
• Kaohsiung Medical University: collaborator

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 80756, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: June 7, 2024
• Study Start: September 26, 2017
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)