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

Alzheimer Disease Clinical Trial

Official title:

Development of a Personalized Intervention to Motivate Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05599425
• Other study ID #: R21AG075328
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2022
• Source: Rhode Island Hospital
• Contact: Laura Korthauer, PhD
• Phone: 4014444500
• Email: laura_korthauer[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 69 Years

Eligibility

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 e4 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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Behavioral:
• Enhanced Healthy Living Education
24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change
• Basic Healthy Living Education
24-session healthy living education program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Threat of Alzheimer's Disease Scale	7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat	baseline
Primary	Perceived Threat of Alzheimer's Disease Scale	7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat	4 weeks
Primary	Perceived Threat of Alzheimer's Disease Scale	7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat	8 weeks
Primary	Perceived Threat of Alzheimer's Disease Scale	7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat	12 weeks (treatment endpoint)
Primary	Dementia Awareness Questionnaire	self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness	baseline
Primary	Dementia Awareness Questionnaire	self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness	4 weeks
Primary	Dementia Awareness Questionnaire	self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness	8 weeks
Primary	Dementia Awareness Questionnaire	self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness	12 weeks
Primary	Generalized Self-Efficacy Scale	10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy	baseline
Primary	Generalized Self-Efficacy Scale	10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy	4 weeks
Primary	Generalized Self-Efficacy Scale	10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy	8 weeks
Primary	Generalized Self-Efficacy Scale	10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy	12 weeks
Secondary	Mediterranean Diet Assessment Tool	14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence	baseline
Secondary	Mediterranean Diet Assessment Tool	14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence	12 weeks
Secondary	CHAMPS Activities Questionnaire for Older Adults	self-report measure of engagement in physical activities, tailored to older adult population; higher scores indicate greater engagement in physical activity	baseline
Secondary	CHAMPS Activities Questionnaire for Older Adults	self-report measure of engagement in physical activities, tailored to older adult population; higher scores indicate greater engagement in physical activity	12 weeks
Secondary	Florida Cognitive Activities Scale	25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity	baseline
Secondary	Florida Cognitive Activities Scale	25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity	12 weeks
Secondary	Perceived Stress Scale	10-item measure that assesses perceived stress; higher scores indicate greater perceived stress	baseline
Secondary	Perceived Stress Scale	10-item measure that assesses perceived stress; higher scores indicate greater perceived stress	4 weeks
Secondary	Perceived Stress Scale	10-item measure that assesses perceived stress; higher scores indicate greater perceived stress	8 weeks
Secondary	Perceived Stress Scale	10-item measure that assesses perceived stress; higher scores indicate greater perceived stress	12 weeks
Secondary	Positive and Negative Affect Schedule	20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively	baseline
Secondary	Positive and Negative Affect Schedule	20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively	4 weeks
Secondary	Positive and Negative Affect Schedule	20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively	8 weeks
Secondary	Positive and Negative Affect Schedule	20-item measure that assesses positive and negative emotional experiences, yielding two scores; higher scores indicate greater experience of positive or negative experiences, respectively	12 weeks