Recruiting

Health Behavior Change

Sponsor:

Rhode Island Hospital

Code:

NCT05599425

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 45 - 69

Healthy Volunteers: Accepted

Interventions

Enhanced Healthy Living Education

Basic Healthy Living Education

Study Details

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.

Conditions

Alzheimer Disease

Study ID

NCT05599425

Start date

Mar 1, 2024

Status verified date

Apr, 2024

Completion date

Feb 1, 2025

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 69

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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.

Interventions

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

Primary outcome measure

  • Perceived Threat of Alzheimer's Disease Scale [ Time Frame: baseline ]
  • Perceived Threat of Alzheimer's Disease Scale [ Time Frame: 4 weeks ]
  • Perceived Threat of Alzheimer's Disease Scale [ Time Frame: 8 weeks ]
  • Perceived Threat of Alzheimer's Disease Scale [ Time Frame: 12 weeks (treatment endpoint) ]
  • Dementia Awareness Questionnaire [ Time Frame: baseline ]
  • Dementia Awareness Questionnaire [ Time Frame: 4 weeks ]
  • Dementia Awareness Questionnaire [ Time Frame: 8 weeks ]
  • Dementia Awareness Questionnaire [ Time Frame: 12 weeks ]
  • Generalized Self-Efficacy Scale [ Time Frame: baseline ]
  • Generalized Self-Efficacy Scale [ Time Frame: 4 weeks ]
  • Generalized Self-Efficacy Scale [ Time Frame: 8 weeks ]
  • Generalized Self-Efficacy Scale [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Laura Korthauer, PhD

4014444500laura_korthauer@brown.edu

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Laura Korthauer

401-444-4500

More Information

Sponsor

Rhode Island Hospital

Last update posted

Jul 25, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2024-07-25.