Risk of DementiaNCT07831616
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
A study testing Brief lifestyle intervention in people with Risk of Dementia and Dementia, run by Fujian Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risk of Dementia, Dementia
- What is being tested?
- Brief lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Risk of Dementia, Dementia
- Being tested
- Brief lifestyle intervention
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief lifestyle interventionBehavioural
Primary care physicians provide brief lifestyle interventions to older adults at risk of dementia
| Study group | Role | What they receive |
|---|---|---|
| Only assessment | No intervention | Not described |
| brief lifestyle intervention | Active comparator | Not described Receives: Behavioral: Brief lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle Scale for Reducing Dementia Risk
Measured: From the start through the end of the 12-week intervention
Secondary outcomes (3)
Scale of Motivation to Change Lifestyle and Health Behaviors to Reduce Dementia Risk
Measured: From the beginning to the end of the 12-week intervention
Adherence-related outcomes
Adherence-related outcomes included rates of intervention receipt, retention, protocol adherence, and session attendance
Measured: From the start through the end of the 12-week intervention
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."
Measured: From the start through the end of the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk of DementiaStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Yunzhen, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831616
- Sponsor's protocol ID
- FJMU2026183
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07831616
- Acronym / sponsor ID
- FJMU2026183
- Conditions
- Risk of Dementia, Dementia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Only assessment | No intervention | – |
| brief lifestyle intervention | Active comparator | Behavioral: Brief lifestyle intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief lifestyle interventionPrimary care physicians provide brief lifestyle interventions to older adults at risk of dementia | Behavioural | brief lifestyle intervention |
Primary outcome
Lifestyle Scale for Reducing Dementia Risk
Time frame: From the start through the end of the 12-week intervention
3 secondary outcomes
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
Adherence-related outcomes
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Brief lifestyle intervention in people with Risk of Dementia and Dementia, run by Fujian Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifestyle Scale for Reducing Dementia Risk (time frame: From the start through the end of the 12-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.