Health Education for Alzheimer's Disease Prevention

Overseen By Laura Korthauer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Disqualifiers: Schizophrenia, Bipolar, Neurologic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people adopt and maintain healthier lifestyle changes to lower their risk of Alzheimer's disease. Participants will learn about Alzheimer's risk factors and how personal beliefs might influence their ability to maintain health changes. The program has two versions: Basic Healthy Living Education, which focuses on general healthy living tips, and Enhanced Healthy Living Education, which offers additional support to address personal barriers. Good candidates are English speakers with two or more factors, such as being overweight, having high blood pressure, or a family history of Alzheimer's. As an unphased trial, participants can gain valuable insights into lifestyle changes that may reduce their Alzheimer's risk.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for Alzheimer's disease prevention?

Research has shown that programs focusing on diet and exercise can boost brain health. A study in JAMA found that older adults at risk for memory problems improved with these types of programs. Another review of studies combining different lifestyle changes showed these methods can help slow down dementia.

For the Healthy Living Education programs in this trial, these findings suggest they are generally safe. These programs involve simple changes like eating healthier and exercising more, which are part of daily life. They aim to help people understand their health beliefs and make lasting changes to lower the risk of Alzheimer's and other dementias. So far, no evidence of any serious safety issues has emerged with these educational programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these educational programs for Alzheimer's disease prevention because they focus on empowering individuals with knowledge and practical strategies. Unlike typical treatments that might involve medications targeting symptoms, these programs aim to educate people about modifiable risk factors. The Enhanced Healthy Living Education goes a step further by addressing personal health beliefs and behaviors, helping participants to create tailored action plans and find natural rewards to boost self-efficacy. This personalized approach could inspire long-term lifestyle changes that may reduce the risk of developing Alzheimer's.

What evidence suggests that this trial's treatments could be effective for Alzheimer's disease prevention?

Research has shown that lifestyle changes can lower the risk of Alzheimer's disease. This trial will compare two educational interventions designed to promote healthy living. Participants in the "Healthy Living Education" arm will receive basic education on major modifiable risk factors for Alzheimer's disease. The "Enhanced Healthy Living Education" arm will provide additional support, focusing on personal health beliefs and strategies to overcome barriers to maintaining healthy habits. One study found that healthy living, such as regular exercise and a balanced diet, is linked to a reduced risk of Alzheimer's and similar memory problems. Another study found that learning about health risks and overcoming personal challenges can help people maintain these healthy habits. This method addresses several risk factors to effectively combat the onset and progression of dementia. Evidence suggests that making better lifestyle choices and understanding personal health beliefs can be key to delaying or preventing Alzheimer's disease. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for midlife adults aged 45-69 with normal cognition who speak English and have at least two risk factors such as being overweight, high blood pressure, high cholesterol, elevated blood sugar levels, a genetic predisposition to Alzheimer's or a family history of the disease.

Inclusion Criteria

Normal cognition (Minnesota Cognitive Acuity Scale > 52)

English language fluency

I am between 45 and 69 years old.

Exclusion Criteria

Current alcohol or drug use disorder based on self-report

Current enrollment in an AD prevention clinical trial.

History of serious mental illness (i.e., schizophrenia, bipolar disorder)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 24-session program over 12 weeks, focusing on education about Alzheimer's disease risk factors and personal health beliefs.

12 weeks

24 sessions (in-person or virtual)

Follow-up

Participants are monitored for adherence to health behavior changes and assessed on various psychological and cognitive measures.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Basic Healthy Living Education
• Enhanced Healthy Living Education

Trial Overview

The study tests two educational programs aimed at promoting healthy living to prevent Alzheimer's. One program provides basic health education while the other offers enhanced education designed to help participants understand and change their health behaviors long-term.

How Is the Trial Designed?

Group I: Enhanced Healthy Living Education Experimental Treatment 1 Intervention

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.

Group II: Healthy Living Education Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Published Research Related to This Trial

A randomized controlled trial with 721 participants showed that online education featuring a celebrity, like Seth Rogen, significantly improved college students' knowledge about Alzheimer's disease (AD) risk reduction compared to traditional educational methods.

The celebrity-led courses not only increased knowledge but also enhanced hopefulness about AD and willingness to engage in related volunteer work among college students, suggesting that engaging teaching methods can effectively promote awareness and proactive attitudes towards brain health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education Research: Online Alzheimer education for high school and college students: A randomized controlled trial. Saif, N., Niotis, K., Dominguez, M., et al.[2021]

An educational program aimed at older adults significantly improved their expectations about their ability to change behaviors (efficacy expectations) and the expected outcomes of those changes (outcome expectations) related to reducing Alzheimer's disease risk, with 53 participants involved in the study.

The program covered important topics such as cardiovascular health, diet, and mental stimulation, and showed statistically significant improvements in outcome expectations, indicating that education can empower older adults to adopt risk-reducing behaviors for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching primary prevention of Alzheimer's disease: does it make a difference? Clevenger, CK., Cantey, S., Quinn, ME.[2013]

Different professional groups have distinct preferences for sources of healthy lifestyle information, with physicians favoring medical publications, teachers opting for popular scientific publications, researchers valuing interpersonal communication, and engineers leaning towards media like radio and TV.

Factors such as interest in information, awareness, and satisfaction significantly influence the effectiveness of health education among these groups, highlighting the need for tailored communication strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The population's need for information on a healthy life style]. Andreeva, NG., Tsygankova, IV.[2016]

Implementing health promotion and education focused on sustainable food choices in workplaces could be a promising new strategy to combat diet- and lifestyle-related diseases such as cancer and obesity.

This approach aims to improve dietary habits outside the home, potentially offering a more effective alternative to traditional educational methods that have not yielded significant results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of food in the workplace for health promotion and education to the future]. Pezzana, A., Sillano, M., Quirico, E., et al.[2011]

A 45-minute educational program significantly improved health-promoting lifestyle habits among a nationally representative sample of 3822 Serbian adolescents and adults, with notable increases in vegetable consumption and food label reading.

The program led to statistically significant improvements in health-promoting lifestyle scores for diet and physical activity in adolescents, indicating that short-term educational interventions can effectively promote healthier behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines-Driven Educational Intervention Promotes Healthy Lifestyle Among Adolescents and Adults: A Serbian National Longitudinal Study. Đorđić, V., Božić, P., Milanović, I., et al.[2020]

A health education intervention in a prison setting successfully engaged 33 out of 160 inmates, focusing on cardiovascular disease prevention through dietary and exercise recommendations.

The intervention highlighted the need for lifestyle modifications, as a significant portion of participants were found to be at high or moderate cardiovascular risk, indicating that such educational programs can effectively promote healthier living and reduce risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular health education intervention in the Prison of Soria. Martínez-Delgado, MM., Ramírez-López, C.[2017]

The educational manual 'Aches and Pain' significantly improved knowledge about chronic rheumatism among both patients (from 19.9 to 25.6 correct answers) and paramedics (from 23.6 to 30.3 correct answers), indicating its effectiveness as a learning tool.

Patients also showed improved attitudes towards their disease, with better adaptation (from 3.6 to 4.0) and self-help capacity (from 4.0 to 4.3), suggesting that education can empower patients in managing their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of an educational manual on knowledge and attitudes of rheumatic patients and health care workers]. Pacheco, D., Berdichevsky, R., Ballesteros, F., et al.[2007]

Research indicates that factors such as older age, genetics, and certain medical conditions increase the risk of developing Alzheimer's disease, but dietary and lifestyle choices may also play a role in prevention.

At a conference focused on nutrition and brain health, experts proposed 7 preliminary guidelines emphasizing healthy diet and exercise habits to help individuals potentially reduce their risk of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary and lifestyle guidelines for the prevention of Alzheimer's disease. Barnard, ND., Bush, AI., Ceccarelli, A., et al.[2022]

A mobile app intervention called 'Gray Matters' effectively encouraged behavior change in participants, leading to significant improvements in health markers such as high-density lipoprotein cholesterol and body mass index (BMI), with 69.2% of those achieving high engagement reducing their BMI.

The study demonstrated that using a mobile phone as a platform for health education and behavior tracking can motivate individuals to make healthier lifestyle choices, which may help reduce the future risk of developing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Empowering Role of Mobile Apps in Behavior Change Interventions: The Gray Matters Randomized Controlled Trial. Hartin, PJ., Nugent, CD., McClean, SI., et al.[2019]

Patient education programs can significantly enhance self-management of chronic illnesses like diabetes, which is crucial for prevention and lifestyle modification.

Evaluating the effectiveness of these programs is complex due to various influencing factors, including patient demographics, disease characteristics, and healthcare system dynamics, all of which must be considered in research design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures and methods in evaluating patient education programs for chronic illness. Lane, DS., Evans, D.[2019]

Health education initiatives have been shown to effectively change health behaviors, contributing to improved health outcomes, although the specific mechanisms behind this success are not fully understood.

Incorporating preventive services into patient care, especially for high-risk individuals, can enhance the effectiveness of health education efforts, highlighting the growing focus on preventive care in primary healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education for health. A role for physicians and the efficacy of health education efforts. Council on Scientific Affairs. [2016]

Health education aims to change health behaviors to improve health status, but this relationship is less clear when it comes to chronic diseases compared to acute health problems.

Studies show that while health status may improve, the connection between changed behaviors and health outcomes is often ambiguous, suggesting a need to reconsider the assumptions behind health education programs and explore additional factors influencing health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Some notions about assumptions underlying health education. Lorig, K., Laurin, J.[2019]

A pilot study involving 35 older adults in a nursing home showed that a 5-week health education intervention significantly improved their knowledge about Alzheimer's disease and promoted healthier lifestyles.

The results indicate that health education can effectively enhance understanding of Alzheimer's and encourage health-promoting behaviors among elderly individuals, suggesting that such interventions should be implemented in nursing homes to help prevent or manage Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of health education on knowledge about Alzheimer's disease and health-promoting behaviours of older Chinese adults in a nursing home: A pilot study. Du, L., Hu, J.[2017]

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