Zinde Zihin Program to Reduce Alzheimer's Disease Risk in Adults Aged 65 and Older

NCT07244848 | Completed

• 2 other identifiers: MAKU-ZINDEZIHIN-2025Ethics Approval No: GO-2025/10
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the feasibility and implementation of the Zinde Zihin ("Fit Mind") multidomain lifestyle program for older adults aged 65 years and older living in public nursing homes. The program includes cognitive activities, physical exercises, nutrition education, psychosocial engagement, sleep education, and stress-management components delivered in eight structured sessions over four weeks. The primary objective is to examine changes in Alzheimer's Disease Risk Index-Short Form (ANU-ADRI-SF) scores from baseline to post-intervention. Secondary objectives include assessing changes in cognitive activity engagement and affect-related lifestyle factors.

Conditions

Cognitive Decline; Aging; Alzheimer Disease

Keywords

Alzheimer's Disease Risk; Cognitive Health; Aging; Multidomain Lifestyle Intervention; Older Adults

Outcome Measures

Primary Outcomes (1)

• Change in ANU-ADRI-SF Total Risk Score

  The Alzheimer's Disease Risk Index - Short Form (ANU-ADRI-SF; 45 items, 15 subscales) is a self-report instrument summing risk and protective factors; higher total scores indicate higher Alzheimer's disease risk. The primary endpoint is the change score (post - baseline). Negative values indicate risk reduction. Analyses will compare groups adjusting for cluster randomization (ICC).

  Baseline (Week 0) to Post-intervention (Week 4)

Study Arms (2)

Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention

EXPERIMENTAL

Participants in the intervention group received the eight-session Zinde Zihin (Fit Mind) multidomain lifestyle program, which combined cognitive training, moderate physical exercise, nutritional education, and psychosocial stimulation. Sessions were conducted twice weekly for four weeks in small group settings at nursing homes.

Behavioral: Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention

Control Group - Routine Care

NO INTERVENTION

Participants assigned to the control group continued their usual daily activities and standard care routines in the nursing home. They did not receive any structured sessions of the Zinde Zihin (Fit Mind) program or other organized lifestyle interventions during the study period.

Interventions

Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention BEHAVIORAL

The Zinde Zihin (Fit Mind) program is a culturally adapted multidomain lifestyle intervention developed to enhance cognitive health, emotional well-being, and daily functioning in older adults. The program combines four evidence-based components-cognitive training, physical activity, nutritional education, and psychosocial stimulation-delivered in eight 60-75-minute sessions over four weeks. Activities included memory and problem-solving games, balance and stretching exercises, discussions on brain-healthy diets, and group-based art, music, and storytelling exercises to strengthen social engagement and mental resilience. What distinguishes the Zinde Zihin program from other interventions is its cultural adaptation for Turkish older adults living in institutional settings. It integrates traditional Turkish music, storytelling, and collective art creation to increase emotional connection and sustainability. Sessions were held in small groups at nursing homes and facilitated by trained p

Also known as: Fit Mind Program, Multidomain Lifestyle Intervention, Cognitive Health Promotion Program, Healthy Aging Behavioral Program

Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Ages Eligible for Study:
• Years to 80 Years (Older Adult)
• Sexes Eligible for Study:
• All
• Accepts Healthy Volunteers:
• Yes

You may not qualify if:

• Diagnosis of dementia or severe cognitive impairment.
• History of depression or major psychiatric disorder.
• Physical disability or medical condition prevents participation in exercise.
• Attendance in less than two-thirds of the planned intervention sessions.

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Burdur Mehmet Akif Ersoy University Faculty of Health Science

Burdur, 15030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Ayse Sezer Balci, PhD

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the behavioral nature of the intervention, participants and facilitators were aware of group assignments. However, data collection and statistical analysis were conducted by independent researchers who were blinded to group allocation to minimize bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD, RN - Department of Public Health Nursing, Burdur Mehmet Akif Ersoy University

Model Details: Intervention Model Description: Participants are individually randomized into two parallel groups (intervention and control). The intervention group receives the Zinde Zihin multidomain lifestyle program, delivered in eight structured sessions over four weeks. The program includes cognitive stimulation, physical activity, nutrition education, psychosocial engagement, and sleep/stress management activities. Sessions are group-based and facilitated by a trained researcher. The control group receives routine nursing home activities without any additional structured intervention. Baseline and post-intervention assessments are administered to all participants. The model aims to examine changes in Alzheimer's Disease Risk Index scores and related lifestyle factors under a parallel assignment design.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: April 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: August 1, 2024
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)