Zinde Zihin Program to Reduce Alzheimer's Disease Risk in Adults Aged 65 and Older (ZZ-MIND)

November 20, 2025 updated by: Ayse Sezer Balci, Burdur Mehmet Akif Ersoy University

Effects of the Zinde Zihin Multidomain Lifestyle Program on Alzheimer's Disease Risk: A Two-Center Controlled Intervention Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Zinde Zihin ("Fit Mind") Program is a multidomain lifestyle intervention designed to promote healthy cognitive aging among older adults. The intervention integrates cognitive training, physical activity, nutritional education, psychosocial engagement, and sleep/stress management techniques within a group-based framework. The program is delivered in eight structured sessions over four weeks, with each session lasting approximately 60-75 minutes.

Study Rationale Lifestyle factors such as cognitive stimulation, physical activity, sleep, and social engagement play an important role in cognitive health. Multidomain interventions involving these components may support healthy aging. This study was developed to examine the feasibility of such an intervention in Turkish nursing home settings.

Study Design This is an individually randomized, controlled pretest-posttest study conducted in two public nursing homes. Randomization is performed at the individual level after eligibility screening. The protocol follows CONSORT guidelines for individually randomized trials.

Participants Eligible participants are adults aged 65 years or older with a Mini-Mental State Examination (MMSE) score ≥23 who are able to communicate verbally and volunteer to participate. Exclusion criteria include diagnosed dementia, major psychiatric illness, severe sensory impairment preventing participation, or unwillingness to attend intervention sessions.

Intervention

Eight structured sessions are delivered to the intervention group:

  • Orientation and baseline assessment
  • Cognitive stimulation activities
  • Emotional well-being and social interaction activities
  • Physical activity and brain-health education
  • Creative expression and art-based engagement
  • Nutrition and brain-healthy dietary education
  • Sleep education and relaxation techniques
  • Reflection, feedback, and post-test assessment

The control group receives routine nursing home activities only.

Outcome Measures

Primary Outcome:

The Alzheimer's Disease Risk Index-Short Form (ANU-ADRI-SF), a self-report instrument assessing demographic, lifestyle, and medical factors associated with Alzheimer's disease risk. Scores are collected at baseline and at 4 weeks.

Secondary Outcomes:

Measures assessing cognitive activity participation and affect-related lifestyle factors, collected at baseline and 4 weeks.

Randomization and Allocation Concealment Participants are randomized using a computer-generated list stratified by institution. Allocation is concealed through sequentially numbered, opaque, sealed envelopes prepared by an independent researcher.

Blinding Due to the nature of the intervention, participants and facilitators cannot be blinded. Outcome assessors and data analysts remain blinded.

Ethics The study was approved by the Burdur Mehmet Akif Ersoy University Ethics Committee (GO 2025/1069). Written informed consent is obtained from all participants.

Data Collection and Timing Baseline and post-intervention assessments are administered individually by the researcher in a private room within the nursing homes.

Statistical Analysis Plan Descriptive statistics and statistical procedures appropriate to the data structure will be applied. Analyses will be conducted according to the predefined analysis plan.

Study Type

Interventional

Enrollment (Actual)

62

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

  • Turkey (Türkiye)
      • Burdur, Turkey (Türkiye), 15030
        • Burdur Mehmet Akif Ersoy University Faculty of Health Science

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

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Ages Eligible for Study:

65 Years to 80 Years (Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Exclusion Criteria:

  • 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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention
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

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

Other Names:
  • Fit Mind Program
  • Multidomain Lifestyle Intervention
  • Cognitive Health Promotion Program
  • Healthy Aging Behavioral Program
No Intervention: Control Group - Routine Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ANU-ADRI-SF Total Risk Score
Time Frame: Baseline (Week 0) to Post-intervention (Week 4)
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)

Collaborators and Investigators

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

Sponsor

Burdur Mehmet Akif Ersoy University

Investigators

  • Principal Investigator: Ayse Sezer Balci, PhD, Burdur Mehmet Akif Ersoy University

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)

April 1, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAKU-ZINDEZIHIN-2025
  • Ethics Approval No: GO-2025/10 (Other Identifier: Burdur Mehmet Akif Ersoy University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data will not be shared because the dataset contains sensitive personal health information collected from older adults living in nursing homes. Only aggregate (group-level) data will be published in scientific journals upon request.

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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