Community DwellingNCT07282626
Effectiveness of Active Brain Construction Program in Community-Dwelling Older Adults
A study testing ABC program with coaching and Active comparator (ABC Program) in people with Community Dwelling and Elderly Adults, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The urgency of health promotion and dementia prevention is paramount. In 2019, the World Health Organization announced the "Risk reduction of cognitive decline and dementia," which reviewed evidence-based prevention aspects and deduced 12 preventative dimensions, all related to lifestyle adjustments. Read more about this study
- Who is it for?
- Ages 55 to 99 years
- Conditions the study is for
- Community Dwelling, Elderly Adults, Lifestyle Risk Reduction
- What is being tested?
- ABC program with coaching and Active comparator (ABC Program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Nov 2023to 30 Nov 2025
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 55 and older
- reside in the community
- independently care for themselves and go outside to attend activities.
- can read and write sentences, comprehend conversations, and communicate appropriately.
Who cannot join
- Individuals diagnosed with neurological conditions
- dementia
- mild cognitive impairment
- stroke.
Trial locations and contacts
1 site in 1 country.
About this study
The urgency of health promotion and dementia prevention is paramount. In 2019, the World Health Organization announced the "Risk reduction of cognitive decline and dementia," which reviewed evidence-based prevention aspects and deduced 12 preventative dimensions, all related to lifestyle adjustments. Several are also related to chronic disease management. Therefore, referencing the theoretical foundation of chronic disease management and lifestyle interventions, and through the use of coaching skills-including goal setting, action planning, problem-solving, etc.-as indicators of effective behavior change, a 12-week group intervention program is developed for the prevention and delay of disability and dementia. This program aims to promote healthy behaviors, lifestyle changes, and cognitive function effects.
This study aims to investigate whether the "Active Brain Construction Program (ABC Program)," led by trainers with coaching skills, can promote behavior participation in a dementia-preventive healthy lifestyle among community-dwelling elders, as well as enhance their health status and cognitive function. Furthermore, it compares the cognitive enhancement effects on community-dwelling elders between the coached and non-coached "Active Brain Construction Program (ABC Program)" against a control group.
This study is a quasi-experimental non-randomized controlled trial, arranging three groups (experimental group, active control group, and control group) for comparison: 1) the coached "Brain-Healthy Lifestyle Reformation Course" group, 2) the general "Brain-Healthy Lifestyle Reformation Course" group, and 3) the control group (e.g., physical fitness class, nutrition courses). The elders undergo assessments before and after the course, including the collection of basic data. The primary effectiveness indicators are: the Health-Promoting Lifestyle Profile-Taiwan Short Form (HELP-T-SF) and the Goal Achievement Scale (GAS), with GAS measuring the experimental and active control groups; the secondary indicators include: the questionnaire for the Prevention and Delay of Disability Care for the Elderly (program effectiveness evaluation), the ICOPE Function Self-Assessment Scale for the Elderly - Self-Rating version, and the WHO-5 Well-Being Index. Data analysis collected includes: descriptive statistics of demographic baseline data, paired t-test comparisons of pre- and post-test differences within groups, ANOVA for between-group differences and post-hoc comparisons, and qualitative observational records to aid interpretation during the intervention process.
- Conditions
- Community Dwelling, Elderly Adults, Lifestyle Risk Reduction
- Being tested
- ABC program with coaching, Active comparator (ABC Program)
- Keywords
- Elderly, Community health, Lifestyle intervention, Behavior Change Technique, coaching
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABC program with coachingBehavioural
This program lasts 12 weeks and 2 hours per week and targets community-dwelling older adults aged 60 and above, conducted by a trained occupational therapist or other professionals. The program consists of exercise (muscle strength, aerobic exercise, balance, and cognicise), cognition (attention, memory, spatial concept, language, calculation ability, and cognitive flexibility), and lifestyle factors modification (topics about cognition, exercise, sleep, health and Mediterranean diet, leisure activities, lifestyle arrangement, medication usage, chronic-disease management, fall prevention, emotion, stress, communication, social resources, and closing). Homework was assigned to the participants every week. Based on motivation theory and behavior change techniques, this program adopts behavior change techniques.
Active comparator (ABC Program)Behavioural
This program lasts 12 weeks and 2 hours per week and targets community-dwelling older adults aged 55 and above, conducted by a trained occupational therapist or other professionals. The program consists of exercise (muscle strength, aerobic exercise, balance, and cognicise), cognition (attention, memory, spatial concept, language, calculation ability, and cognitive flexibility), and lifestyle factors modification (topics about cognition, exercise, sleep, health and Mediterranean diet, leisure activities, lifestyle arrangement, medication usage, chronic-disease management, fall prevention, emotion, stress, communication, social resources, and closing). Homework was assigned to the participants every week. Compared to the experiment group, there is no coaching techniques involved.
| Study group | Role | What they receive |
|---|---|---|
| ABC program with coaching | Experimental | ABC program with coaching techniques Receives: Behavioral: Active comparator (ABC Program) |
| ABC program | Active comparator | ABC program without coaching techniques Receives: Behavioral: ABC program with coaching |
| others | Sham comparator | other programs such as exercise or art program Receives: Behavioral: ABC program with coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Enhancement Lifestyle Profile -Taiwanese Version -Short Form
The original version contains a total of 56 items, categorized into the following subscales: 1) Exercise, 2) Diet, 3) Productive or Social Activities, 4) Leisure, 5) Activities of Daily Living, 6) Stress Management and Spiritual Participation, and 7) Other Health Promotion and Risk Behaviors. The complete original Taiwanese version consists of 59 items using a 3-point scale, and the HELP-T-SF consisted of 20 items, demonstrating acceptable internal consistency (Cronbach's alpha = 0.781) and test-retest reliability (ICC = 0.782). All items significantly correlated with the total score (0.303 to 0.535) and with the original HELP-T (0.749). Criterion-related validity showed moderate correlations with well-being and quality of life. The short form also resulted in significant time savings, requiring only 15-20 minutes to complete.
Measured: Perioperative/Periprocedural
Secondary outcomes (2)
Outcome Measurement of Health-Promotion Program for Community-Dwelling Elderly
The questionnaire consists of 20 items encompassing five dimensions: cognition, muscle strength, functional living, nutritional oral health, and psychosocial aspects, with four items dedicated to each dimension. The overall reliability and validity are good, with internal consistency (Cronbach's α = 0.82) and test-retest reliability (ICC = 0.927). The questionnaire shows a moderate correlation with the Kihon Checklist and can significantly distinguish between healthy individuals and those with dementia.
Measured: Perioperative/Periprocedural
Integrated care for older people (ICOPE)
The assessment includes a total of 8 items across six key dimensions: cognition, behavior, nutrition, hearing, vision, and depression. If any responses indicate abnormalities, functional issues can be detected early, allowing for timely interventions such as exercise and nutritional management.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start9 Nov 2023
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community DwellingStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282626
- Sponsor's protocol ID
- 202310063RINA
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Active Brain Construction Program in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT07282626
- Acronym / sponsor ID
- 202310063RINA
- Conditions
- Community Dwelling, Elderly Adults, Lifestyle Risk Reduction
- Keywords
- Elderly, Community health, Lifestyle intervention, Behavior Change Technique, coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 15 Dec 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.
The urgency of health promotion and dementia prevention is paramount. In 2019, the World Health Organization announced the "Risk reduction of cognitive decline and dementia," which reviewed evidence-based prevention aspects and deduced 12 preventative dimensions, all related to lifestyle adjustments. Several are also related to chronic disease management. Therefore, referencing the theoretical foundation of chronic disease management and lifestyle interventions, and through the use of coaching skills-including goal setting, action planning, problem-solving, etc.-as indicators of effective behavior change, a 12-week group intervention program is developed for the prevention and delay of disability and dementia. This program aims to promote healthy behaviors, lifestyle changes, and cognitive function effects.
This study aims to investigate whether the "Active Brain Construction Program (ABC Program)," led by trainers with coaching skills, can promote behavior participation in a dementia-preventive healthy lifestyle among community-dwelling elders, as well as enhance their health status and cognitive function. Furthermore, it compares the cognitive enhancement effects on community-dwelling elders between the coached and non-coached "Active Brain Construction Program (ABC Program)" against a control group.
This study is a quasi-experimental non-randomized controlled trial, arranging three groups (experimental group, active control group, and control group) for comparison: 1) the coached "Brain-Healthy Lifestyle Reformation Course" group, 2) the general "Brain-Healthy Lifestyle Reformation Course" group, and 3) the control group (e.g., physical fitness class, nutrition courses). The elders undergo assessments before and after the course, including the collection of basic data. The primary effectiveness indicators are: the Health-Promoting Lifestyle Profile-Taiwan Short Form (HELP-T-SF) and the Goal Achievement Scale (GAS), with GAS measuring the experimental and active control groups; the secondary indicators include: the questionnaire for the Prevention and Delay of Disability Care for the Elderly (program effectiveness evaluation), the ICOPE Function Self-Assessment Scale for the Elderly - Self-Rating version, and the WHO-5 Well-Being Index. Data analysis collected includes: descriptive statistics of demographic baseline data, paired t-test comparisons of pre- and post-test differences within groups, ANOVA for between-group differences and post-hoc comparisons, and qualitative observational records to aid interpretation during the intervention process.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABC program with coaching | Experimental | Behavioral: Active comparator (ABC Program)ABC program with coaching techniques |
| ABC program | Active comparator | Behavioral: ABC program with coachingABC program without coaching techniques |
| others | Sham comparator | Behavioral: ABC program with coachingother programs such as exercise or art program |
Who may qualify
- Ages
- 55 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 55 and older
- reside in the community
- independently care for themselves and go outside to attend activities.
- can read and write sentences, comprehend conversations, and communicate appropriately.
Key exclusion criteria (4 listed)
- Individuals diagnosed with neurological conditions
- dementia
- mild cognitive impairment
- stroke.
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 |
|---|---|---|
| ABC program with coachingThis program lasts 12 weeks and 2 hours per week and targets community-dwelling older adults aged 60 and above, conducted by a trained occupational therapist or other professionals. The program consists of exercise (muscle strength, aerobic exercise, balance, and cognicise), cognition (attention, memory, spatial concept, language, calculation ability, and cognitive flexibility), and lifestyle factors modification (topics about cognition, exercise, sleep, health and Mediterranean diet, leisure activities, lifestyle arrangement, medication usage, chronic-disease management, fall prevention, emotion, stress, communication, social resources, and closing). Homework was assigned to the participants every week. Based on motivation theory and behavior change techniques, this program adopts behavior change techniques. | Behavioural | ABC program, others |
| Active comparator (ABC Program)This program lasts 12 weeks and 2 hours per week and targets community-dwelling older adults aged 55 and above, conducted by a trained occupational therapist or other professionals. The program consists of exercise (muscle strength, aerobic exercise, balance, and cognicise), cognition (attention, memory, spatial concept, language, calculation ability, and cognitive flexibility), and lifestyle factors modification (topics about cognition, exercise, sleep, health and Mediterranean diet, leisure activities, lifestyle arrangement, medication usage, chronic-disease management, fall prevention, emotion, stress, communication, social resources, and closing). Homework was assigned to the participants every week. Compared to the experiment group, there is no coaching techniques involved. | Behavioural | ABC program with coaching |
Primary outcome
Health Enhancement Lifestyle Profile -Taiwanese Version -Short Form
Time frame: Perioperative/Periprocedural
The original version contains a total of 56 items, categorized into the following subscales: 1) Exercise, 2) Diet, 3) Productive or Social Activities, 4) Leisure, 5) Activities of Daily Living, 6) Stress Management and Spiritual Participation, and 7) Other Health Promotion and Risk Behaviors. The complete original Taiwanese version consists of 59 items using a 3-point scale, and the HELP-T-SF consisted of 20 items, demonstrating acceptable internal consistency (Cronbach's alpha = 0.781) and test-retest reliability (ICC = 0.782). All items significantly correlated with the total score (0.303 to 0.535) and with the original HELP-T (0.749). Criterion-related validity showed moderate correlations with well-being and quality of life. The short form also resulted in significant time savings, requiring only 15-20 minutes to complete.
2 secondary outcomes
Outcome Measurement of Health-Promotion Program for Community-Dwelling Elderly
Time frame: Perioperative/Periprocedural
Integrated care for older people (ICOPE)
Time frame: Perioperative/Periprocedural
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 15 Dec 2025.
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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 ABC program with coaching and Active comparator (ABC Program) in people with Community Dwelling and Elderly Adults, run by National Taiwan University Hospital 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 4 inclusion and 4 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 15 Dec 2025. 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. 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?
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?
Health Enhancement Lifestyle Profile -Taiwanese Version -Short Form (time frame: Perioperative/Periprocedural). 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 15 Dec 2025.