Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Development of a Personalized Intervention to Motivate Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Behavioral: Enhanced Healthy Living Education
* Behavioral: Basic Healthy Living Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Living Education<br>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 | Behavioral: Basic Healthy Living Education<br>* 24-session healthy living education program<br>|
| Experimental: Enhanced Healthy Living Education<br>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. | Behavioral: Enhanced Healthy Living Education<br>* 24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | baseline | 
| Dementia Awareness Questionnaire | 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 | 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 | 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 | 10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy | baseline | 
| Generalized Self-Efficacy Scale | 10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy | 4 weeks | 
| Generalized Self-Efficacy Scale | 10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy | 8 weeks | 
| Generalized Self-Efficacy Scale | 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 | 14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence | baseline | 
| Mediterranean Diet Assessment Tool | 14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence | 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 | 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 | 12 weeks | 
| Florida Cognitive Activities Scale | 25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity | baseline | 
| Florida Cognitive Activities Scale | 25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity | 12 weeks | 
| Perceived Stress Scale | 10-item measure that assesses perceived stress; higher scores indicate greater perceived stress | baseline | 
| Perceived Stress Scale | 10-item measure that assesses perceived stress; higher scores indicate greater perceived stress | 4 weeks | 
| Perceived Stress Scale | 10-item measure that assesses perceived stress; higher scores indicate greater perceived stress | 8 weeks | 
| Perceived Stress Scale | 10-item measure that assesses perceived stress; higher scores indicate greater perceived stress | 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 | 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 | 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 | 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 | 12 weeks |