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

Not Applicable

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Behavioral: Basic Healthy Living Education; Behavioral: Enhanced Healthy Living Education

• Registration Number: NCT05599425
• Lead Sponsor: Rhode Island Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-31
• Study Start: 2024-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25
• Primary Completion: 2024-12-30
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Living Education	Basic 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
Enhanced Healthy Living Education	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.

Primary Outcome Measures

Name	Time	Method
Generalized Self-Efficacy Scale	12 weeks	10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
Perceived Threat of Alzheimer's Disease Scale	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
Dementia Awareness Questionnaire	12 weeks	self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness

Secondary Outcome Measures

Name	Time	Method
Florida Cognitive Activities Scale	12 weeks	25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity
Mediterranean Diet Assessment Tool	12 weeks	14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence
CHAMPS Activities Questionnaire for Older Adults	12 weeks	self-report measure of engagement in physical activities, tailored to older adult population; higher scores indicate greater engagement in physical activity
Perceived Stress Scale	12 weeks	10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
Positive and Negative Affect Schedule	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

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States