MindfulnessMMP-DTLANCT07025655
Effectiveness of a Mindfulness and Digital Technology Program for Healthy Aging (MMP-DTLA)
A study testing Multifaceted Mindfulness Program in people with Mindfulness and Healthy Aging, run by Chang Gung University of Science and Technology.
Trial summary
This study aims to evaluate the effectiveness of a mindfulness program integrated with digital technology-assisted learning on healthy aging among community-dwelling older adults. In a randomized controlled trial, 100 participants will be randomly assigned to either an experimental or a control group. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mindfulness, Healthy Aging
- What is being tested?
- Multifaceted Mindfulness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 11 Jun 2025to 30 Apr 2027
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ability to communicate in Mandarin or Taiwanese
- aged 65 years or older in the community
- Currently using a mobile phone and the LINE application as a means of communication.
Who cannot join
- Individuals with cognitive impairments
- Unable to communicate verbally
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of a Multifaceted Mindfulness Program Integrated With Digital Technology-Assisted Learning on Healthy Aging in Community-Dwelling Older Adults: A Randomized Controlled Trial
This study aims to evaluate the effectiveness of a mindfulness program integrated with digital technology-assisted learning on healthy aging among community-dwelling older adults. In a randomized controlled trial, 100 participants will be randomly assigned to either an experimental or a control group. The experimental group will receive a ten-week mindfulness program supported by digital tools such as educational videos and LINE Bot messaging. Primary outcomes include mindfulness awareness, physical activity, heart rate variability, cognitive function, sleep quality, perception of aging, and healthy aging perspectives. Additionally, qualitative interviews will be conducted with 10 experimental group participants to explore their intervention experiences.
- Conditions
- Mindfulness, Healthy Aging
- Being tested
- Multifaceted Mindfulness Program, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted Mindfulness ProgramBehavioural
Also called Mindfulness
Ten-week mindfulness classes
PlaceboBehavioural
Regular daily activity
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Ten-week mindfulness programs supported by digital technology-assisted teaching materials Receives: Behavioral: Multifaceted Mindfulness Program |
| Control | Placebo comparator | No intervention Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mindfulness awareness
The Five Facet Mindfulness Questionnaire (FFMQ) will be used. Items are rated on a 5-point Likert scale ranging from 5 (almost always) to 1 (never), with higher scores indicating greater frequency. Certain items are reverse-coded, and total scores are computed after adjusting for these items. A higher total score reflects a greater level of mindfulness.
Measured: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Physical activity: PASE-C
The PASE-C encompasses domains including total physical activity, leisure activities, household activities, and occupational activities. Higher scores indicate greater levels of physical activity.
Measured: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Physical activity: SPPB
The SPPB comprises three components: balance tests, gait speed tests, and chair stand tests. A total score ranging from 0 to 9 indicates mobility impairment, whereas a score between 10 and 12 reflects normal mobility function.
Measured: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Cognitive function
The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive function among community-dwelling older adults. The total score ranges from 0 to 30, with higher scores indicating better overall cognitive functioning. A score of 26 or above is generally considered within the normal range.
Measured: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Heart rate variability: SDNN
Heart rate variability (HRV) was assessed using a monitoring device to evaluate autonomic nervous system activity. The standard deviation of normal-to-normal intervals (SDNN) reflects the variability in RR intervals from electrocardiogram recordings, with higher SDNN values indicating greater heart rate variability.
Measured: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Heart rate variability: LF/HF ratio
Heart rate variability (HRV) was assessed using a monitoring device to evaluate autonomic nervous system activity. Sympathetic and parasympathetic activity were assessed through frequency-domain measures, including low-frequency (LF) and high-frequency (HF) components. The LF/HF ratio was calculated to evaluate the balance of autonomic nervous system activity.
Measured: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Sleep quality
The study utilized the Pittsburgh Sleep Quality Index (PSQI) to measure sleep quality. The Pittsburgh Sleep Quality Index (PSQI) yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 is indicative of clinically significant sleep disturbance.
Measured: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Perception of ageing
The perception of ageing was measured using the Brief Aging Perceptions Questionnaire (B-APQ). A 5-point Likert scale was used for scoring, with 1 indicating 'strongly disagree,' 2 'disagree,' 3 'neutral,' 4 'agree,' and 5 'strongly agree.' Higher scores reflect more positive perceptions of aging.
Measured: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Healthy ageing perspectives
The Healthy Aging Perspectives Questionnaire (HAPQ) will be used. This questionnaire adopts a 5-point Likert scale, where 1 indicates 'strongly disagree,' 2 'disagree,' 3 'neutral,' 4 'agree,' and 5 'strongly agree.' Higher scores indicate more positive perspective of healthy aging.
Measured: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start11 Jun 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Yu-Rung Wang, Chang Gung University of Science and Technology
- Investigators
- Yu-Rung Wang, PhD, Principal investigator, Chang Gung University of Science and Technology, Chiayi Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025655
- Sponsor's protocol ID
- 202400087B0C6001
- Other IDs
- NSTC 113-2410-H-255 -001 -MY2
- Acronym
- MMP-DTLA
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is for the participants' privacy and research ethics.
Publications
Wang YR, Lee HF, Hsieh PL, Chang CH, Chen CM. Relationship between physical activity and perceptions of ageing from the perspective of healthy ageing among older people with frailty with chronic disease: a cross-sectional study. BMC Nurs. 2023 Sep 16;22(1):319. doi: 10.1186/s12912-023-01481-9.
PubMed 37716946
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Multifaceted Mindfulness Program Integrated With Digital Technology-Assisted Learning on Healthy Aging in Community-Dwelling Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07025655
- Acronym / sponsor ID
- MMP-DTLA / 202400087B0C6001
- Conditions
- Mindfulness, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 11 Jun 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Jun 2025 (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.
This study aims to evaluate the effectiveness of a mindfulness program integrated with digital technology-assisted learning on healthy aging among community-dwelling older adults. In a randomized controlled trial, 100 participants will be randomly assigned to either an experimental or a control group. The experimental group will receive a ten-week mindfulness program supported by digital tools such as educational videos and LINE Bot messaging. Primary outcomes include mindfulness awareness, physical activity, heart rate variability, cognitive function, sleep quality, perception of aging, and healthy aging perspectives. Additionally, qualitative interviews will be conducted with 10 experimental group participants to explore their intervention experiences.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Multifaceted Mindfulness ProgramTen-week mindfulness programs supported by digital technology-assisted teaching materials |
| Control | Placebo comparator | Behavioral: PlaceboNo intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ability to communicate in Mandarin or Taiwanese
- aged 65 years or older in the community
- Currently using a mobile phone and the LINE application as a means of communication.
Key exclusion criteria (2 listed)
- Individuals with cognitive impairments
- Unable to communicate verbally
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 |
|---|---|---|
| Multifaceted Mindfulness ProgramAlso: MindfulnessTen-week mindfulness classes | Behavioural | Mindfulness |
| PlaceboRegular daily activity | Behavioural | Control |
Primary outcome
mindfulness awareness
Time frame: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The Five Facet Mindfulness Questionnaire (FFMQ) will be used. Items are rated on a 5-point Likert scale ranging from 5 (almost always) to 1 (never), with higher scores indicating greater frequency. Certain items are reverse-coded, and total scores are computed after adjusting for these items. A higher total score reflects a greater level of mindfulness.
Physical activity: PASE-C
Time frame: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The PASE-C encompasses domains including total physical activity, leisure activities, household activities, and occupational activities. Higher scores indicate greater levels of physical activity.
Physical activity: SPPB
Time frame: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The SPPB comprises three components: balance tests, gait speed tests, and chair stand tests. A total score ranging from 0 to 9 indicates mobility impairment, whereas a score between 10 and 12 reflects normal mobility function.
Cognitive function
Time frame: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive function among community-dwelling older adults. The total score ranges from 0 to 30, with higher scores indicating better overall cognitive functioning. A score of 26 or above is generally considered within the normal range.
Heart rate variability: SDNN
Time frame: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Heart rate variability (HRV) was assessed using a monitoring device to evaluate autonomic nervous system activity. The standard deviation of normal-to-normal intervals (SDNN) reflects the variability in RR intervals from electrocardiogram recordings, with higher SDNN values indicating greater heart rate variability.
Heart rate variability: LF/HF ratio
Time frame: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Heart rate variability (HRV) was assessed using a monitoring device to evaluate autonomic nervous system activity. Sympathetic and parasympathetic activity were assessed through frequency-domain measures, including low-frequency (LF) and high-frequency (HF) components. The LF/HF ratio was calculated to evaluate the balance of autonomic nervous system activity.
Sleep quality
Time frame: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The study utilized the Pittsburgh Sleep Quality Index (PSQI) to measure sleep quality. The Pittsburgh Sleep Quality Index (PSQI) yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 is indicative of clinically significant sleep disturbance.
Perception of ageing
Time frame: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The perception of ageing was measured using the Brief Aging Perceptions Questionnaire (B-APQ). A 5-point Likert scale was used for scoring, with 1 indicating 'strongly disagree,' 2 'disagree,' 3 'neutral,' 4 'agree,' and 5 'strongly agree.' Higher scores reflect more positive perceptions of aging.
Healthy ageing perspectives
Time frame: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The Healthy Aging Perspectives Questionnaire (HAPQ) will be used. This questionnaire adopts a 5-point Likert scale, where 1 indicates 'strongly disagree,' 2 'disagree,' 3 'neutral,' 4 'agree,' and 5 'strongly agree.' Higher scores indicate more positive perspective of healthy aging.
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 17 Jun 2025.
- Results publication: PubMed 37716946Wang YR, Lee HF, Hsieh PL, Chang CH, Chen CM. Relationship between physical activity and perceptions of ageing from the perspective of healthy ageing among older people with frailty with chronic disease: a cross-sectional study. BMC Nurs. 2023 Sep 16;22(1):319. doi: 10.1186/s12912-023-01481-9.
- Using the mindfullness practice for the development of the programLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This is for the participants' privacy and research ethics.
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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.
Yu-Rung Wang, PhD principal investigator
Chang Gung University of Science and Technology, Chiayi Campus
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted Mindfulness Program in people with Mindfulness and Healthy Aging, run by Chang Gung University of Science and Technology.
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 2 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: opening soon, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Yu-Rung Wang, PhD (88653628800, daisy025@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mindfulness awareness (time frame: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07025655, which also lists 1 linked publication.
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 17 Jun 2025.