Development and Empirical Evaluation of a Brief Lifestyle Intervention for Older Adults at Risk of Dementia Within an Integrated Medical-Preventive Grid-Based Service Model

September 15, 2026 updated by: Chen Yunzhen, Fujian Medical University

Lifestyle factors are among the most important modifiable risk factors for dementia, and primary prevention through lifestyle interventions is considered the most cost-effective approach to reducing the incidence of dementia. However, traditional face-to-face interventions have limitations that hinder large-scale implementation. With the development of primary healthcare systems, the delivery of simple, feasible, and brief lifestyle interventions within primary care settings offers a promising avenue for the continuous management and early prevention of dementia risk in older adults.

In this study, brief lifestyle interventions were administered to older adults at risk of dementia by registered physicians at community health service centers.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 60 years
  • CAIDE dementia risk score ≥ 6
  • Possessing basic comprehension and verbal expression abilities
  • Voluntarily participating in the study and signing the informed consent form
  • Not participating in other clinical trials during the intervention period.

Exclusion Criteria:

  • Individuals already diagnosed with dementia
  • individuals with severe heart, liver, or kidney disease
  • individuals with severe chronic diseases and comorbidities (e.g., congestive heart failure, or hypertension or diabetes with severe complications)
  • individuals with severe visual or hearing impairment.

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Only assessment
Active Comparator: brief lifestyle intervention
Behavioral: Brief lifestyle intervention

Primary care physicians provide brief lifestyle interventions to older adults at risk of dementia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lifestyle Scale for Reducing Dementia Risk
Time Frame: From the start through the end of the 12-week intervention
From the start through the end of the 12-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scale of Motivation to Change Lifestyle and Health Behaviors to Reduce Dementia Risk
Time Frame: From the beginning to the end of the 12-week intervention
From the beginning to the end of the 12-week intervention
Adherence-related outcomes
Time Frame: From the start through the end of the 12-week intervention

Adherence-related outcomes included rates of intervention receipt, retention, protocol adherence, and session attendance
From the start through the end of the 12-week intervention
Readiness to change behaviour
Time Frame: From the start through the end of the 12-week intervention

4 for "Already working on improvement," 3 for "Intending to improve," 2 for "No intention to improve," and 1 for "No improvement needed."
From the start through the end of the 12-week intervention

Collaborators and Investigators

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

Sponsor

Fujian Medical 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 (Estimated)

September 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 21, 2026

Study Record Updates

Last Update Posted (Actual)

September 21, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJMU2026183

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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