Quality of LifeNCT06447883
Influence of Lifestyle Modification Program on Meaningful Participation and Quality of Life of Independent Taiwanese Older Adults
A study testing Lifestyle modification program in people with Quality of Life, run by Hui-Jen Shyu at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Lifestyle modification program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Sep 2017to 24 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 55 years old
- independently community-dwelling
- proficient in Mandarin Chinese or Taiwanese
Who cannot join
- -show overt signs of psychosis or dementia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Lifestyle modification program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modification programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: pre-intervention, during the intervention, and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start26 Sep 2017
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hui-Jen Shyu
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Medical University
- Responsible party
- Sponsor-investigator, Hui-Jen Shyu, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447883
- Sponsor's protocol ID
- KMUHIRB-E(I)-20170158
- Status last verified
- Jun 2024
- First submitted
- 15 Feb 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Lifestyle Modification Program on Meaningful Participation and Quality of Life of Independent Taiwanese Older Adults
- ClinicalTrials.gov ID
- NCT06447883
- Acronym / sponsor ID
- KMUHIRB-E(I)-20170158
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hui-Jen ShyuUniversity, hospital or other
- Collaborators
- Kaohsiung Medical University
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 7 Jun 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification program | Experimental | Behavioral: Lifestyle modification programThe 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 | No intervention | –The control group participants were selected from the same community as the experimental group but did not receive the LMP. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 55 years old
- independently community-dwelling
- proficient in Mandarin Chinese or Taiwanese
Key exclusion criteria (1 listed)
- -show overt signs of psychosis or dementia
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 |
|---|---|---|
| Lifestyle modification programThe 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. | Behavioural | Lifestyle modification program |
Primary outcome
SF-36 Taiwan version
Time frame: pre-intervention and immediately after the intervention
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.
Taiwanese version of the Meaningful Activity Participation Assessment
Time frame: pre-intervention and immediately after the intervention
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.
Individual semi-structured interviews
Time frame: pre-intervention, during the intervention, and immediately after the intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification program in people with Quality of Life, run by Hui-Jen Shyu 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 3 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: finished, as of the sponsor's last update on 7 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SF-36 Taiwan version (time frame: pre-intervention and immediately after the intervention). The study lists 3 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 7 Jun 2024.