Effectiveness of Active Brain Construction Program in Community-Dwelling Older Adults

December 1, 2025 updated by: National Taiwan University Hospital

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 Overview

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kaohsiung City, Taiwan, 807
        • Communities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

Individuals diagnosed with neurological conditions

  • dementia
  • mild cognitive impairment
  • stroke.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABC program with coaching
ABC program with coaching techniques
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.
Active Comparator: ABC program
ABC program without coaching techniques
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.
Sham Comparator: others
other programs such as exercise or art program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Perioperative/Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome Measurement of Health-Promotion Program for Community-Dwelling Elderly
Time Frame: Perioperative/Periprocedural
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.
Perioperative/Periprocedural
Integrated care for older people (ICOPE)
Time Frame: Perioperative/Periprocedural
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.
Perioperative/Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202310063RINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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