Clinical trial NCT05599425: Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
Official title: Development of a Personalized Intervention to Motivate Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Threat of Alzheimer's Disease Scale
timeFrame: baseline
measure: Perceived Threat of Alzheimer's Disease Scale
timeFrame: 4 weeks
measure: Perceived Threat of Alzheimer's Disease Scale
timeFrame: 8 weeks
measure: Perceived Threat of Alzheimer's Disease Scale
timeFrame: 12 weeks (treatment endpoint)
measure: Dementia Awareness Questionnaire
timeFrame: baseline
measure: Dementia Awareness Questionnaire
timeFrame: 4 weeks
measure: Dementia Awareness Questionnaire
timeFrame: 8 weeks
measure: Dementia Awareness Questionnaire
timeFrame: 12 weeks
measure: Generalized Self-Efficacy Scale
timeFrame: baseline
measure: Generalized Self-Efficacy Scale
timeFrame: 4 weeks
measure: Generalized Self-Efficacy Scale
timeFrame: 8 weeks
measure: Generalized Self-Efficacy Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Mediterranean Diet Assessment Tool
timeFrame: baseline
measure: Mediterranean Diet Assessment Tool
timeFrame: 12 weeks
measure: CHAMPS Activities Questionnaire for Older Adults
timeFrame: baseline
measure: CHAMPS Activities Questionnaire for Older Adults
timeFrame: 12 weeks
measure: Florida Cognitive Activities Scale
timeFrame: baseline
measure: Florida Cognitive Activities Scale
timeFrame: 12 weeks
measure: Perceived Stress Scale
timeFrame: baseline
measure: Perceived Stress Scale
timeFrame: 4 weeks
measure: Perceived Stress Scale
timeFrame: 8 weeks
measure: Perceived Stress Scale
timeFrame: 12 weeks
measure: Positive and Negative Affect Schedule
timeFrame: baseline
measure: Positive and Negative Affect Schedule
timeFrame: 4 weeks
measure: Positive and Negative Affect Schedule
timeFrame: 8 weeks
measure: Positive and Negative Affect Schedule
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References: