Alzheimer DiseaseNCT05599425
Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
A study testing Enhanced Healthy Living Education and Basic Healthy Living Education in people with Alzheimer Disease, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Modifying health behaviors like physical activity level, diet, stress, and mental activity level can lower risk for Alzheimer's disease, but many middle-aged and older adults find it difficult to sustain health behavior changes over the long term. Read more about this study
- Who is it for?
- Ages 45 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Enhanced Healthy Living Education and Basic Healthy Living Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Feb 2025
- 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 45 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 45-69 years
- normal cognition (Minnesota Cognitive Acuity Scale > 52)
- English language fluency
- at least two of the following: i) BMI > 24.9; ii) systolic blood pressure > 125 mmHg; iii) LDL cholesterol > 115 mg/dL; iv) HbA1C > 6.0%; v) at least one APOE ε4 allele; vi) first-degree relative with AD.
Who cannot join
- history of serious mental illness (i.e., schizophrenia, bipolar disorder)
- history of neurologic or neurodevelopmental disorder
- current alcohol or drug use disorder based on self-report
- current enrollment in an AD prevention clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Laura Korthauer, 401-444-4500
About this study
Official title: Development of a Personalized Intervention to Motivate Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
Modifying health behaviors like physical activity level, diet, stress, and mental activity level can lower risk for Alzheimer's disease, but many middle-aged and older adults find it difficult to sustain health behavior changes over the long term. This project will develop a new intervention that educates people about Alzheimer's disease risk factors and helps them understand how their personal health beliefs may prevent them from making long-lasting lifestyle changes. The goal is to help people sustain health behavior changes to prevent or delay the onset of Alzheimer's disease and related dementias.
- Conditions
- Alzheimer Disease
- Being tested
- Enhanced Healthy Living Education, Basic Healthy Living Education
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Healthy Living EducationBehavioural
24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change
Basic Healthy Living EducationBehavioural
24-session healthy living education program
| Study group | Role | What they receive |
|---|---|---|
| Healthy Living Education | Active comparator | The basic healthy living education intervention is a 24-session program (two sessions/week for 12 weeks) designed to educate participants about major modifiable risk factors for Alzheimer's disease. The first session each week is didactic, intended to increase knowledge about each Alzheimer's disease risk factor. The second session involves repetition and practice of didactic material as well as strategizing cues to action Receives: Behavioral: Basic Healthy Living Education |
| Enhanced Healthy Living Education | Experimental | The enhanced healthy living education intervention will include the same didactic content as the basic HLE course for the first session each week. The second session will focus on personal health beliefs and how they affect specific health behaviors. This may include discussing perceived benefits, troubleshooting barriers to action, making specific action plans, and implementing natural reward systems to bolster self-efficacy. Receives: Behavioral: Enhanced Healthy Living Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Threat of Alzheimer's Disease Scale
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Measured: baseline
Perceived Threat of Alzheimer's Disease Scale
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Measured: 4 weeks
Perceived Threat of Alzheimer's Disease Scale
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Measured: 8 weeks
Perceived Threat of Alzheimer's Disease Scale
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Measured: 12 weeks (treatment endpoint)
Dementia Awareness Questionnaire
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Measured: baseline
Dementia Awareness Questionnaire
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Measured: 4 weeks
Dementia Awareness Questionnaire
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Measured: 8 weeks
Dementia Awareness Questionnaire
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Measured: 12 weeks
Generalized Self-Efficacy Scale
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
Measured: baseline
Generalized Self-Efficacy Scale
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
Measured: 4 weeks
Generalized Self-Efficacy Scale
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
Measured: 8 weeks
Generalized Self-Efficacy Scale
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
Measured: 12 weeks
Secondary outcomes (14)
Mediterranean Diet Assessment Tool
14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence
Measured: baseline
Mediterranean Diet Assessment Tool
14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence
Measured: 12 weeks
CHAMPS Activities Questionnaire for Older Adults
self-report measure of engagement in physical activities, tailored to older adult population; higher scores indicate greater engagement in physical activity
Measured: baseline
CHAMPS Activities Questionnaire for Older Adults
self-report measure of engagement in physical activities, tailored to older adult population; higher scores indicate greater engagement in physical activity
Measured: 12 weeks
Florida Cognitive Activities Scale
25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity
Measured: baseline
Florida Cognitive Activities Scale
25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity
Measured: 12 weeks
Perceived Stress Scale
10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
Measured: baseline
Perceived Stress Scale
10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
Measured: 4 weeks
Perceived Stress Scale
10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
Measured: 8 weeks
Perceived Stress Scale
10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
Measured: 12 weeks
Positive and Negative Affect Schedule
20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
Measured: baseline
Positive and Negative Affect Schedule
20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
Measured: 4 weeks
Positive and Negative Affect Schedule
20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
Measured: 8 weeks
Positive and Negative Affect Schedule
20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Mar 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
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 Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599425
- Sponsor's protocol ID
- R21AG075328
- Status last verified
- Apr 2024
- First submitted
- 19 Oct 2022
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Korthauer LE, Rosen RK, Tremont G, Davis JD. Intervention Development for Tailored Education for Aging and Cognitive Health (TEACH) for Dementia Prevention in Midlife Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 16;13:e60395. doi: 10.2196/60395.
PubMed 39412840
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Personalized Intervention to Motivate Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05599425
- Acronym / sponsor ID
- R21AG075328
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 31 Oct 2022 (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.
Modifying health behaviors like physical activity level, diet, stress, and mental activity level can lower risk for Alzheimer's disease, but many middle-aged and older adults find it difficult to sustain health behavior changes over the long term. This project will develop a new intervention that educates people about Alzheimer's disease risk factors and helps them understand how their personal health beliefs may prevent them from making long-lasting lifestyle changes. The goal is to help people sustain health behavior changes to prevent or delay the onset of Alzheimer's disease and related dementias.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Living Education | Active comparator | Behavioral: Basic Healthy Living EducationThe basic healthy living education intervention is a 24-session program (two sessions/week for 12 weeks) designed to educate participants about major modifiable risk factors for Alzheimer's disease. The first session each week is didactic, intended to increase knowledge about each Alzheimer's disease risk factor. The second session involves repetition and practice of didactic material as well as strategizing cues to action |
| Enhanced Healthy Living Education | Experimental | Behavioral: Enhanced Healthy Living EducationThe enhanced healthy living education intervention will include the same didactic content as the basic HLE course for the first session each week. The second session will focus on personal health beliefs and how they affect specific health behaviors. This may include discussing perceived benefits, troubleshooting barriers to action, making specific action plans, and implementing natural reward systems to bolster self-efficacy. |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 45-69 years
- normal cognition (Minnesota Cognitive Acuity Scale > 52)
- English language fluency
- at least two of the following: i) BMI > 24.9; ii) systolic blood pressure > 125 mmHg; iii) LDL cholesterol > 115 mg/dL; iv) HbA1C > 6.0%; v) at least one APOE ε4 allele; vi) first-degree relative with AD.
Key exclusion criteria (4 listed)
- history of serious mental illness (i.e., schizophrenia, bipolar disorder)
- history of neurologic or neurodevelopmental disorder
- current alcohol or drug use disorder based on self-report
- current enrollment in an AD prevention clinical trial.
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 |
|---|---|---|
| Enhanced Healthy Living Education24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change | Behavioural | Enhanced Healthy Living Education |
| Basic Healthy Living Education24-session healthy living education program | Behavioural | Healthy Living Education |
Primary outcome
Perceived Threat of Alzheimer's Disease Scale
Time frame: baseline
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Perceived Threat of Alzheimer's Disease Scale
Time frame: 4 weeks
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Perceived Threat of Alzheimer's Disease Scale
Time frame: 8 weeks
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Perceived Threat of Alzheimer's Disease Scale
Time frame: 12 weeks (treatment endpoint)
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Dementia Awareness Questionnaire
Time frame: baseline
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Dementia Awareness Questionnaire
Time frame: 4 weeks
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Dementia Awareness Questionnaire
Time frame: 8 weeks
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Dementia Awareness Questionnaire
Time frame: 12 weeks
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Generalized Self-Efficacy Scale
Time frame: baseline
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
Generalized Self-Efficacy Scale
Time frame: 4 weeks
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
Generalized Self-Efficacy Scale
Time frame: 8 weeks
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
Generalized Self-Efficacy Scale
Time frame: 12 weeks
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
14 secondary outcomes
Mediterranean Diet Assessment Tool
Time frame: baseline
Mediterranean Diet Assessment Tool
Time frame: 12 weeks
CHAMPS Activities Questionnaire for Older Adults
Time frame: baseline
CHAMPS Activities Questionnaire for Older Adults
Time frame: 12 weeks
Florida Cognitive Activities Scale
Time frame: baseline
Florida Cognitive Activities Scale
Time frame: 12 weeks
Perceived Stress Scale
Time frame: baseline
Perceived Stress Scale
Time frame: 4 weeks
Perceived Stress Scale
Time frame: 8 weeks
Perceived Stress Scale
Time frame: 12 weeks
Positive and Negative Affect Schedule
Time frame: baseline
Positive and Negative Affect Schedule
Time frame: 4 weeks
Positive and Negative Affect Schedule
Time frame: 8 weeks
Positive and Negative Affect Schedule
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Derived from this study: PubMed 39412840Korthauer LE, Rosen RK, Tremont G, Davis JD. Intervention Development for Tailored Education for Aging and Cognitive Health (TEACH) for Dementia Prevention in Midlife Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 16;13:e60395. doi: 10.2196/60395.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Healthy Living Education and Basic Healthy Living Education in people with Alzheimer Disease, run by Rhode Island 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 4 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: status not confirmed, as of the sponsor's last update on 25 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Korthauer, PhD (4014444500, laura_korthauer@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Threat of Alzheimer's Disease Scale (time frame: baseline). The study lists 12 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 NCT05599425, 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 25 Jul 2024.