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

NCT ID: NCT06447883

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-26
• Study Completion Date: 2019-05-24

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.

Detailed Description

This study investigates the impact of a Lifestyle Modification Program (LMP) on the quality of life and meaningful participation of independent Taiwanese older adults. As the global and Taiwanese populations age rapidly, there's an urgent need to address the challenges posed by aging, including deteriorations in physical and mental health that affect independent living and well-being. Inspired by USC's Lifestyle Redesign® Program, this research aimed to adapt and evaluate a similar intervention in a Taiwanese context, considering cultural differences and specific needs.

Participants in the experimental and control groups were required to be over 55 years old, independently living in the community, proficient in Mandarin Chinese or Taiwanese, and showing no overt signs of psychosis or dementia. The study was conducted with ethical approval from Kaohsiung Medical University's IRB, ensuring confidentiality and informed consent.

The experimental group received the LMP which included 12 treatment modules delivered in 24 weekly group sessions, emphasizing active engagement, knowledge sharing, and personal exploration. The intervention aimed to foster psychophysical health, increase daily activity participation, and enhance overall quality of life through a large group format over a shorter timeframe than traditional interventions. The control group participants were selected from the same community without engaged in the LMP.

The study used the SF-36 Taiwan version to measure health-related quality of life and the Taiwanese Meaningful Activity Participation Assessment (T-MAPA) to evaluate the frequency and degree of meaningful participation, and then to compared the changed scores between the two groups in order to examine the efficacy of the LMP. Additionally, individual semi-structured interviews were conducted to acquire qualitative insights into participants' subjective experiences before, during, and after the intervention among the experimental group.

Conditions

Quality of Life

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Lifestyle modification program

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.

Group Type: EXPERIMENTAL

Lifestyle modification program

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle modification program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-show overt signs of psychosis or dementia

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaohsiung Medical University

OTHER

Sponsor Role: collaborator

Hui-Jen Shyu

OTHER

Sponsor Role: lead

Responsible Party

Hui-Jen Shyu

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kaohsiung Medical University

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KMUHIRB-E(I)-20170158

Identifier Type: -

Identifier Source: org_study_id