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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Behavioral: Basic Healthy Living Education; Behavioral: Enhanced Healthy Living Education

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Korthauer, PhD; Phone Number: 4014444500; Email: laura_korthauer@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
      • Contact: Laura Korthauer; Phone Number: 401-444-4500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: Basic Healthy Living Education; 24-session healthy living education program
Experimental: 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.	Behavioral: Enhanced Healthy Living Education; 24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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)
Dementia Awareness Questionnaire	self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness	baseline
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
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
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
Generalized Self-Efficacy Scale	10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy	baseline
Generalized Self-Efficacy Scale	10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy	4 weeks
Generalized Self-Efficacy Scale	10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy	8 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mediterranean Diet Assessment Tool	14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence	baseline
Mediterranean Diet Assessment Tool	14-item measure of adherence to a Mediterranean type diet; higher scores indicate greater diet adherence	12 weeks
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
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
Florida Cognitive Activities Scale	25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity	baseline
Florida Cognitive Activities Scale	25-item self-report measure about engagement in mentally stimulating activities; higher scores indicate greater cognitive activity	12 weeks
Perceived Stress Scale	10-item measure that assesses perceived stress; higher scores indicate greater perceived stress	baseline
Perceived Stress Scale	10-item measure that assesses perceived stress; higher scores indicate greater perceived stress	4 weeks
Perceived Stress Scale	10-item measure that assesses perceived stress; higher scores indicate greater perceived stress	8 weeks
Perceived Stress Scale	10-item measure that assesses perceived stress; higher scores indicate greater perceived stress	12 weeks
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
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
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
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

Collaborators and Investigators

• Sponsor: Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: R21AG075328 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No