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

NCT ID: NCT05599425

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-02-01

Brief Summary

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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

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Basic Healthy Living Education

Intervention Type BEHAVIORAL

24-session healthy living education program

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.

Group Type EXPERIMENTAL

Enhanced Healthy Living Education

Intervention Type BEHAVIORAL

24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change

Interventions

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Enhanced Healthy Living Education

24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change

Intervention Type BEHAVIORAL

Basic Healthy Living Education

24-session healthy living education program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Laura Korthauer, PhD

Role: CONTACT

4014444500

Facility Contacts

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Laura Korthauer

Role: primary

401-444-4500

References

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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.

Reference Type DERIVED
PMID: 39412840 (View on PubMed)

Other Identifiers

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R21AG075328

Identifier Type: NIH

Identifier Source: org_study_id

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