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

NCT ID: NCT07282626

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-09
• Study Completion Date: 2025-11-30

Brief 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. 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ABC program with coaching

ABC program with coaching techniques

Group Type: EXPERIMENTAL

Active comparator (ABC Program)

Intervention Type: BEHAVIORAL

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.

ABC program

ABC program without coaching techniques

Group Type: ACTIVE_COMPARATOR

ABC program with coaching

Intervention Type: BEHAVIORAL

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.

others

other programs such as exercise or art program

Group Type: SHAM_COMPARATOR

ABC program with coaching

Intervention Type: BEHAVIORAL

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.

Interventions

ABC program with coaching

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Communities

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

202310063RINA

Identifier Type: -

Identifier Source: org_study_id