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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05599425
Other study ID # R21AG075328
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date April 30, 2024

Study information

Verified date October 2022
Source Rhode Island Hospital
Contact Laura Korthauer, PhD
Phone 4014444500
Email laura_korthauer@brown.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 69 Years
Eligibility 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 e4 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Enhanced Healthy Living Education
24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change
Basic Healthy Living Education
24-session healthy living education program

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rhode Island Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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)
Primary Dementia Awareness Questionnaire self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness baseline
Primary 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
Primary 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
Primary 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
Primary Generalized Self-Efficacy Scale 10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy baseline
Primary Generalized Self-Efficacy Scale 10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy 4 weeks
Primary Generalized Self-Efficacy Scale 10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy 8 weeks
Primary 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 Mediterranean Diet Assessment Tool 14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence baseline
Secondary Mediterranean Diet Assessment Tool 14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence 12 weeks
Secondary 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
Secondary 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
Secondary Florida Cognitive Activities Scale 25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity baseline
Secondary Florida Cognitive Activities Scale 25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity 12 weeks
Secondary Perceived Stress Scale 10-item measure that assesses perceived stress; higher scores indicate greater perceived stress baseline
Secondary Perceived Stress Scale 10-item measure that assesses perceived stress; higher scores indicate greater perceived stress 4 weeks
Secondary Perceived Stress Scale 10-item measure that assesses perceived stress; higher scores indicate greater perceived stress 8 weeks
Secondary Perceived Stress Scale 10-item measure that assesses perceived stress; higher scores indicate greater perceived stress 12 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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