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

Primary Purpose

Alzheimer Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced Healthy Living Education
Basic Healthy Living Education
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease

Eligibility Criteria

45 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Healthy Living Education

    Enhanced Healthy Living Education

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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
    Dementia Awareness Questionnaire
    self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
    Dementia Awareness Questionnaire
    self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
    Dementia Awareness Questionnaire
    self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
    Dementia Awareness Questionnaire
    self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
    Generalized Self-Efficacy Scale
    10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
    Generalized Self-Efficacy Scale
    10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
    Generalized Self-Efficacy Scale
    10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
    Generalized Self-Efficacy Scale
    10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy

    Secondary Outcome Measures

    Mediterranean Diet Assessment Tool
    14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence
    Mediterranean Diet Assessment Tool
    14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence
    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
    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
    Florida Cognitive Activities Scale
    25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity
    Florida Cognitive Activities Scale
    25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity
    Perceived Stress Scale
    10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
    Perceived Stress Scale
    10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
    Perceived Stress Scale
    10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
    Perceived Stress Scale
    10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
    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
    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
    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
    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

    Full Information

    First Posted
    October 19, 2022
    Last Updated
    October 25, 2022
    Sponsor
    Rhode Island Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05599425
    Brief Title
    Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
    Official Title
    Development of a Personalized Intervention to Motivate Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    April 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rhode Island Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Living Education
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Enhanced Healthy Living Education
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhanced Healthy Living Education
    Intervention Description
    24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change
    Intervention Type
    Behavioral
    Intervention Name(s)
    Basic Healthy Living Education
    Intervention Description
    24-session healthy living education program
    Primary Outcome Measure Information:
    Title
    Perceived Threat of Alzheimer's Disease Scale
    Description
    7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
    Time Frame
    baseline
    Title
    Perceived Threat of Alzheimer's Disease Scale
    Description
    7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
    Time Frame
    4 weeks
    Title
    Perceived Threat of Alzheimer's Disease Scale
    Description
    7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
    Time Frame
    8 weeks
    Title
    Perceived Threat of Alzheimer's Disease Scale
    Description
    7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
    Time Frame
    12 weeks (treatment endpoint)
    Title
    Dementia Awareness Questionnaire
    Description
    self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
    Time Frame
    baseline
    Title
    Dementia Awareness Questionnaire
    Description
    self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
    Time Frame
    4 weeks
    Title
    Dementia Awareness Questionnaire
    Description
    self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
    Time Frame
    8 weeks
    Title
    Dementia Awareness Questionnaire
    Description
    self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
    Time Frame
    12 weeks
    Title
    Generalized Self-Efficacy Scale
    Description
    10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
    Time Frame
    baseline
    Title
    Generalized Self-Efficacy Scale
    Description
    10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
    Time Frame
    4 weeks
    Title
    Generalized Self-Efficacy Scale
    Description
    10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
    Time Frame
    8 weeks
    Title
    Generalized Self-Efficacy Scale
    Description
    10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Mediterranean Diet Assessment Tool
    Description
    14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence
    Time Frame
    baseline
    Title
    Mediterranean Diet Assessment Tool
    Description
    14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence
    Time Frame
    12 weeks
    Title
    CHAMPS Activities Questionnaire for Older Adults
    Description
    self-report measure of engagement in physical activities, tailored to older adult population; higher scores indicate greater engagement in physical activity
    Time Frame
    baseline
    Title
    CHAMPS Activities Questionnaire for Older Adults
    Description
    self-report measure of engagement in physical activities, tailored to older adult population; higher scores indicate greater engagement in physical activity
    Time Frame
    12 weeks
    Title
    Florida Cognitive Activities Scale
    Description
    25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity
    Time Frame
    baseline
    Title
    Florida Cognitive Activities Scale
    Description
    25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity
    Time Frame
    12 weeks
    Title
    Perceived Stress Scale
    Description
    10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
    Time Frame
    baseline
    Title
    Perceived Stress Scale
    Description
    10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
    Time Frame
    4 weeks
    Title
    Perceived Stress Scale
    Description
    10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
    Time Frame
    8 weeks
    Title
    Perceived Stress Scale
    Description
    10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
    Time Frame
    12 weeks
    Title
    Positive and Negative Affect Schedule
    Description
    20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
    Time Frame
    baseline
    Title
    Positive and Negative Affect Schedule
    Description
    20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
    Time Frame
    4 weeks
    Title
    Positive and Negative Affect Schedule
    Description
    20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
    Time Frame
    8 weeks
    Title
    Positive and Negative Affect Schedule
    Description
    20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laura Korthauer, PhD
    Phone
    4014444500
    Email
    laura_korthauer@brown.edu

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs