NCT07282626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 18, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
Last Updated

December 15, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

November 18, 2024

Last Update Submit

December 1, 2025

Conditions

Keywords

ElderlyCommunity healthLifestyle interventionBehavior Change Techniquecoaching

Outcome Measures

Primary Outcomes (1)

  • 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.

    Perioperative/Periprocedural

Secondary Outcomes (2)

  • Outcome Measurement of Health-Promotion Program for Community-Dwelling Elderly

    Perioperative/Periprocedural

  • Integrated care for older people (ICOPE)

    Perioperative/Periprocedural

Study Arms (3)

ABC program with coaching

EXPERIMENTAL

ABC program with coaching techniques

Behavioral: Active comparator (ABC Program)

ABC program

ACTIVE COMPARATOR

ABC program without coaching techniques

Behavioral: ABC program with coaching

others

SHAM COMPARATOR

other programs such as exercise or art program

Behavioral: ABC program with coaching

Interventions

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.

ABC programothers

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 with coaching

Eligibility Criteria

Age55 Years - 99 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals diagnosed with neurological conditions
  • dementia
  • mild cognitive impairment
  • stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Communities

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2024

First Posted

December 15, 2025

Study Start

November 9, 2023

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

December 15, 2025

Record last verified: 2025-11

Locations