- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05599425
Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
October 25, 2022 updated by: Rhode Island Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Laura Korthauer, PhD
- Phone Number: 4014444500
- Email: laura_korthauer@brown.edu
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
45 years to 69 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Healthy Living Education
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
|
24-session healthy living education program
|
EXPERIMENTAL: Enhanced Healthy Living Education
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.
|
24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline
|
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
|
4 weeks
|
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
|
8 weeks
|
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
|
12 weeks (treatment endpoint)
|
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
|
baseline
|
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
|
4 weeks
|
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
|
8 weeks
|
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
|
12 weeks
|
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
|
baseline
|
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
|
4 weeks
|
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
|
8 weeks
|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mediterranean Diet Assessment Tool
Time Frame: baseline
|
14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence
|
baseline
|
Mediterranean Diet Assessment Tool
Time Frame: 12 weeks
|
14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence
|
12 weeks
|
CHAMPS Activities Questionnaire for Older Adults
Time Frame: baseline
|
self-report measure of engagement in physical activities, tailored to older adult population; higher scores indicate greater engagement in physical activity
|
baseline
|
CHAMPS Activities Questionnaire for Older Adults
Time Frame: 12 weeks
|
self-report measure of engagement in physical activities, tailored to older adult population; higher scores indicate greater engagement in physical activity
|
12 weeks
|
Florida Cognitive Activities Scale
Time Frame: baseline
|
25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity
|
baseline
|
Florida Cognitive Activities Scale
Time Frame: 12 weeks
|
25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity
|
12 weeks
|
Perceived Stress Scale
Time Frame: baseline
|
10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
|
baseline
|
Perceived Stress Scale
Time Frame: 4 weeks
|
10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
|
4 weeks
|
Perceived Stress Scale
Time Frame: 8 weeks
|
10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
|
8 weeks
|
Perceived Stress Scale
Time Frame: 12 weeks
|
10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
|
12 weeks
|
Positive and Negative Affect Schedule
Time Frame: baseline
|
20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
|
baseline
|
Positive and Negative Affect Schedule
Time Frame: 4 weeks
|
20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
|
4 weeks
|
Positive and Negative Affect Schedule
Time Frame: 8 weeks
|
20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
|
8 weeks
|
Positive and Negative Affect Schedule
Time Frame: 12 weeks
|
20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ANTICIPATED)
April 1, 2023
Primary Completion (ANTICIPATED)
April 30, 2024
Study Completion (ANTICIPATED)
April 30, 2024
Study Registration Dates
First Submitted
October 19, 2022
First Submitted That Met QC Criteria
October 25, 2022
First Posted (ACTUAL)
October 31, 2022
Study Record Updates
Last Update Posted (ACTUAL)
October 31, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AG075328 (NIH)
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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