Memory Loss (Excluding Dementia)NCT07424443
Pilot Study of a Brain Health Program in Senior Centers
A study testing My Healthy Brain in people with Memory Loss (Excluding Dementia) and Lifestyle (Sedentary Behavior and Physical Activity), run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators will evaluate a brain health programs in older adults with subjective cognitive decline. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the program delivered in the senior centers. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Memory Loss (Excluding Dementia), Lifestyle (Sedentary Behavior and Physical Activity), Lifestyle Risk Reduction
- What is being tested?
- My Healthy Brain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 50
- Subjective cognitive decline (SCD; e.g., forgetting information, getting lost, and repeating oneself)
- Able to self-identify at least 1 modifiable lifestyle risk factors for dementia to change during the program (physically inactive, poor sleep, non-adherence to Mediterranean diet, alcohol use, tobacco use, socially isolated or lonely, mental inactivity)
- Absence of significant cognitive impairment (assessed using Short Blessed Test71 ≤ 9)
- Self-reported English proficiency/literacy
- Ability and willingness to participate and complete all study-related activities
Who cannot join
- Dementia or other neurodegenerative disease per patient self-report or disclosure
- Psychosis, uncontrolled schizophrenia or schizoaffective disorder, uncontrolled bipolar disorder, or uncontrolled substance dependence/abuse
- Active self-report of suicidal ideation / high risk of suicide
- Serious medical illness expected to worsen during the study
- Self-reported safety issues with initiating lifestyle change
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Prevention Starts Here: Piloting My Healthy Brain in Massachusetts Councils on Aging
The investigators will evaluate a brain health programs in older adults with subjective cognitive decline. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the program delivered in the senior centers.
Read the detailed description
The investigators aim to promote brain health by reducing lifestyle risk factors for dementia in older adults with subjective cognitive decline (SCD). This study is a pilot trial of a mindfulness-based lifestyle programs. Eligible older adults include: age ≥ 50, self-reported worry about changes in memory or thinking, and self-reported interest in improving lifestyle behaviors. Participants complete 8 weekly 90-minute sessions delivered by a clinical psychologist or trainee. All participants will wear an activity watch to support and monitor lifestyle changes during the program. Each session will focus on a different topic relevant to brain health (e.g. physical activity, sleep, etc.). The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the program, delivered in senior centers.
- Conditions
- Memory Loss (Excluding Dementia), Lifestyle (Sedentary Behavior and Physical Activity), Lifestyle Risk Reduction, Healthy Lifestyle Behaviors, Dementia Prevention
- Being tested
- My Healthy Brain
- Keywords
- Cogntive Aging, Health Promotion, Mindfulness, Community Health Services, Feasibility Studies, Alzheimer Disease / prevention & control, Exercise, Diet, Sleep, Social Interaction, Cognitive Stimulation, Smoking, Alcohol Drinking
- Medical subject headings
- Memory Disorders, Sedentary Behavior, Motor Activity, Risk Reduction Behavior, Alzheimer Disease, Smoking, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Healthy BrainBehavioural
My Healthy Brain is an 8-week group program delivered via 90-minute meetings led by a clinical psychologist pr trainee. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain participants wear an activity watch to monitor lifestyle changes during the program.
| Study group | Role | What they receive |
|---|---|---|
| My Healthy Brain | Experimental | My Healthy Brain is an 8-week group program delivered via 90-minute meetings led by a clinical psychologist or trainee. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain participants wear an activity watch to monitor lifestyle changes during the program. Receives: Behavioral: My Healthy Brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Treatment Completion
We will assess the acceptability of treatment by calculating the proportion of participants who attend ≥ 6/8 treatment sessions (≥ 70% good, ≥ 80% excellent).
Measured: 8 Weeks
Client Satisfaction Questionnaire
Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction (≥ 70% good, ≥ 80% excellent)
Measured: 8 Weeks
Secondary outcomes (8)
Credibility and Expectancy Questionnaire
Assesses how believable, convincing, and logical patients perceive the treatment to be. Higher scores (min = 3, max = 27) scores indicate greater credibility and expectancy (≥70% good, ≥ 80% excellent)
Measured: 0 Weeks
Rates of Recruitment
We will assess the feasibility of recruiting and enrolling participants into the study by calculating the proportion who agree to screen divided by the total number contacted (≥70% good, ≥ 80% excellent).
Measured: 0 Weeks
Rate of Enrollment
Proportion of participants who agree to enroll from the total deemed eligible to participate (≥70% good, ≥ 80% excellent)
Measured: 0 Weeks
Rates of Valid Activity Watch Data (10 or more hours of wear time)
We will assess the feasibility of collecting valid activity watch data by calculating the proportion of participants who wore the watch at least 5 out of 7 days per week for at least 10 or more hours per day, divided by the total number of days in the program (≥ 70% good, ≥ 80% excellent).
Measured: 8 Weeks
Rates of Missing Outcomes Data
We will assess the feasibility of data collection by calculating the proportion of secondary outcomes (cognition and lifestyle) with no missing data divided by the total number collected (≥70% good, ≥ 80% excellent).
Measured: 8 Weeks
Rates of Staff Fidelity to Study Procedures
We will collect and report the number of protocol deviations.
Measured: 8 Weeks
Rate of Adverse Events
We will collect and report participant's self-reported adverse events.
Measured: 8 Weeks
Modified Patient Global Impression of Change
The proportion of participants who report perceived improvements in cognitive function, lifestyle, and emotional well-being outcomes (1=Very Much Worse, 7=Very Much Improved).
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start6 Jan 2026
- Primary completion25 Aug 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory Loss (Excluding Dementia)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open pilot study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Association of Councils on Aging and Senior Center Directors, Inc.
- Responsible party
- Principal investigator, Ryan A., Mace, PHD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424443
- Sponsor's protocol ID
- 2025P002540
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mace RA, Law ME, Cohen JE, Ritchie CS, Okereke OI, Hoeppner BB, Brewer JA, Bartels SJ, Vranceanu AM; My Healthy Brain Team. A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 21;13:e64149. doi: 10.2196/64149.
PubMed 39571150
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Starts Here: Piloting My Healthy Brain in Massachusetts Councils on Aging
- ClinicalTrials.gov ID
- NCT07424443
- Acronym / sponsor ID
- 2025P002540
- Conditions
- Memory Loss (Excluding Dementia), Lifestyle (Sedentary Behavior and Physical Activity), Lifestyle Risk Reduction, Healthy Lifestyle Behaviors, Dementia Prevention
- Keywords
- Cogntive Aging, Health Promotion, Mindfulness, Community Health Services, Feasibility Studies, Alzheimer Disease / prevention & control, Exercise, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Association of Councils on Aging and Senior Center Directors, Inc.
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 20 Feb 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.
The investigators will evaluate a brain health programs in older adults with subjective cognitive decline. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the program delivered in the senior centers.
Detailed description
The investigators aim to promote brain health by reducing lifestyle risk factors for dementia in older adults with subjective cognitive decline (SCD). This study is a pilot trial of a mindfulness-based lifestyle programs. Eligible older adults include: age ≥ 50, self-reported worry about changes in memory or thinking, and self-reported interest in improving lifestyle behaviors. Participants complete 8 weekly 90-minute sessions delivered by a clinical psychologist or trainee. All participants will wear an activity watch to support and monitor lifestyle changes during the program. Each session will focus on a different topic relevant to brain health (e.g. physical activity, sleep, etc.). The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the program, delivered in senior centers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open pilot study
| Arm | Type | Receives |
|---|---|---|
| My Healthy Brain | Experimental | Behavioral: My Healthy BrainMy Healthy Brain is an 8-week group program delivered via 90-minute meetings led by a clinical psychologist or trainee. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain participants wear an activity watch to monitor lifestyle changes during the program. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 50
- Subjective cognitive decline (SCD; e.g., forgetting information, getting lost, and repeating oneself)
- Able to self-identify at least 1 modifiable lifestyle risk factors for dementia to change during the program (physically inactive, poor sleep, non-adherence to Mediterranean diet, alcohol use, tobacco use, socially isolated or lonely, mental inactivity)
- Absence of significant cognitive impairment (assessed using Short Blessed Test71 ≤ 9)
- Self-reported English proficiency/literacy
Key exclusion criteria (5 listed)
- Dementia or other neurodegenerative disease per patient self-report or disclosure
- Psychosis, uncontrolled schizophrenia or schizoaffective disorder, uncontrolled bipolar disorder, or uncontrolled substance dependence/abuse
- Active self-report of suicidal ideation / high risk of suicide
- Serious medical illness expected to worsen during the study
- Self-reported safety issues with initiating lifestyle change
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 |
|---|---|---|
| My Healthy BrainMy Healthy Brain is an 8-week group program delivered via 90-minute meetings led by a clinical psychologist pr trainee. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain participants wear an activity watch to monitor lifestyle changes during the program. | Behavioural | My Healthy Brain |
Primary outcome
Rates of Treatment Completion
Time frame: 8 Weeks
We will assess the acceptability of treatment by calculating the proportion of participants who attend ≥ 6/8 treatment sessions (≥ 70% good, ≥ 80% excellent).
Client Satisfaction Questionnaire
Time frame: 8 Weeks
Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction (≥ 70% good, ≥ 80% excellent)
8 secondary outcomes
Credibility and Expectancy Questionnaire
Time frame: 0 Weeks
Rates of Recruitment
Time frame: 0 Weeks
Rate of Enrollment
Time frame: 0 Weeks
Rates of Valid Activity Watch Data (10 or more hours of wear time)
Time frame: 8 Weeks
Rates of Missing Outcomes Data
Time frame: 8 Weeks
Rates of Staff Fidelity to Study Procedures
Time frame: 8 Weeks
Rate of Adverse Events
Time frame: 8 Weeks
Modified Patient Global Impression of Change
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 39571150Mace RA, Law ME, Cohen JE, Ritchie CS, Okereke OI, Hoeppner BB, Brewer JA, Bartels SJ, Vranceanu AM; My Healthy Brain Team. A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 21;13:e64149. doi: 10.2196/64149.
- Individual participant dataSharing planned: No
Related trials for Memory Loss (Excluding Dementia)
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Presymptomatic Disease, Mild Cognitive Impairment
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Healthy Brain in people with Memory Loss (Excluding Dementia) and Lifestyle (Sedentary Behavior and Physical Activity), run by Massachusetts General Hospital at 1 site in United States.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rates of Treatment Completion (time frame: 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07424443, which also lists 1 linked publication.
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 9 Oct 2026.