Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
Development of a Personalized Intervention to Motivate Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable alzheimer-disease
Started Mar 2024
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedJuly 25, 2024
April 1, 2024
10 months
October 19, 2022
July 23, 2024
Conditions
Outcome Measures
Primary Outcomes (12)
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 Outcomes (14)
Mediterranean Diet Assessment Tool
baseline
Mediterranean Diet Assessment Tool
12 weeks
CHAMPS Activities Questionnaire for Older Adults
baseline
CHAMPS Activities Questionnaire for Older Adults
12 weeks
Florida Cognitive Activities Scale
baseline
- +9 more secondary outcomes
Study Arms (2)
Healthy Living Education
ACTIVE COMPARATORThe 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
EXPERIMENTALThe 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.
Interventions
24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change
24-session healthy living education program
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Related Publications (1)
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.
PMID: 39412840DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2022
First Posted
October 31, 2022
Study Start
March 1, 2024
Primary Completion
December 30, 2024
Study Completion
February 1, 2025
Last Updated
July 25, 2024
Record last verified: 2024-04