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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05599425
Enrollment
40
Registered
2022-10-31
Start date
2024-03-01
Completion date
2025-02-01
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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.

Interventions

BEHAVIORALEnhanced Healthy Living Education

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

BEHAVIORALBasic Healthy Living Education

24-session healthy living education program

Sponsors

Rhode Island Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 69 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Perceived Threat of Alzheimer's Disease Scalebaseline7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Dementia Awareness Questionnairebaselineself-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Generalized Self-Efficacy Scalebaseline10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy

Secondary

MeasureTime frameDescription
Perceived Stress Scalebaseline10-item measure that assesses perceived stress; higher scores indicate greater perceived stress
Mediterranean Diet Assessment Toolbaseline14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence
Positive and Negative Affect Schedulebaseline20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively
CHAMPS Activities Questionnaire for Older Adultsbaselineself-report measure of engagement in physical activities, tailored to older adult population; higher scores indicate greater engagement in physical activity
Florida Cognitive Activities Scalebaseline25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity

Countries

United States

Contacts

Primary ContactLaura Korthauer, PhD
laura_korthauer@brown.edu4014444500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026