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

Lifespan

Status: Enrolling

Conditions: Alzheimer Disease

Treatments: Behavioral: Basic Healthy Living Education; Behavioral: Enhanced Healthy Living Education

Study type: Interventional

Funder types: Other

Identifiers

NCT05599425

R21AG075328

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 45 to 69 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Healthy Living Education

Active Comparator group

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

Treatment:

Behavioral: Basic Healthy Living Education

Enhanced Healthy Living Education

Experimental group

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.

Treatment:

Behavioral: Enhanced Healthy Living Education