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Not yet recruitingNCT07831616Updated Sep 21, 2026

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

An interventional study of Brief lifestyle intervention in Risk of Dementia and Dementia, sponsored by Fujian Medical University. Not yet recruiting. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Fujian Medical University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Risk of Dementia
  • Dementia

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03

In context

Dementia

2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.

This study's planned enrollment of 300 is above the median of 90 across 1,758 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Fujian Medical University is the lead sponsor of 148 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form
  • Not participating in other clinical trials during the intervention period.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • No intervention
    Only assessment
  • Active comparator
    brief lifestyle intervention

    Behavioral: Brief lifestyle intervention

Interventions

  • BehavioralBrief lifestyle intervention

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

06

What researchers measure

Primary outcomes

  1. Lifestyle Scale for Reducing Dementia Risk

    Time frame: From the start through the end of the 12-week intervention

Secondary outcomes

  1. 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

  2. Adherence-related outcomes

    Adherence-related outcomes included rates of intervention receipt, retention, protocol adherence, and session attendance

    Time frame: From the start through the end of the 12-week intervention

  3. Readiness to change behaviour

    4 for "Already working on improvement," 3 for "Intending to improve," 2 for "No intention to improve," and 1 for "No improvement needed."

    Time frame: From the start through the end of the 12-week intervention

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jan 2027, 4 months later.

Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 4 months is below that.

Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2026
First posted
Sep 21, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
Jan 15, 2027
CompletionEst.
Apr 15, 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07831616
Responsible party
Chen Yunzhen (student, Fujian Medical University) — Principal investigator
First posted
Sep 21, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Jan 15, 2027 (estimated)
Completion
Apr 15, 2027 (estimated)
Last update
Sep 21, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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