PRogram to Improve Stress-levels and Enhance Memory

NCT ID: NCT05845918

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2026-03-31

Brief Summary

This is a pilot study with the objective to examine if an in-person and a remote multi-component intervention program can improve chronic stress, vascular measures, and executive function among African American and White patients with Mild Cognitive Impairment. Researchers plan to enroll 45 participants with over-recruitment of African American patients. Participants will be recruited to participate in PRogram to Improve Stress-levels and Enhance Memory (PRISEM) (i.e., remote lifestyle intervention program). The participants will be asked to participate in group-based and/or individual activities that focus on improving health education, nutrition, physical activity, cognitive health, stress levels, and overall well-being. The duration of the study for all participants will be 12 months with 3 study visits. At each study visit, the following measures will be assessed: psychosocial, behavioral, vascular/physical, and executive function.

Detailed Description

More than half the patients with Mild Cognitive Impairment (MCI), a transitional state between normal aging and dementia, will develop dementia within five years. Despite the clinical and public health significance of MCI, there are no known pharmacological treatment strategies preventing the progression to Alzheimer's Disease (AD). Disappointing results from clinical trials of AD-modifying interventions have increased efforts to focus on prevention strategies that delay the onset of the disease. Since AD-related pathology begins more than a decade before patients develop symptoms, prevention efforts are likely to be more effective when targeted earlier in life. Data is even more limited on higher-risk groups, such as African Americans, who have double the incidence compared with Whites.

This study plans to enroll a diverse population with an over-enrollment of African Americans because African Americans have a higher risk of developing mild cognitive impairment (MCI) and double the incidence of Alzheimer's Disease (AD) compared with Whites. Unfortunately, the prevention and management of MCI have been understudied among African Americans. Chronic stress (such as perceived discrimination and daily environmental stress) in African Americans can affect cognition and plays a role in the worsening of unhealthy behaviors such as smoking, improper diet, and physical inactivity.

Recent studies have predicted that a 10-25% reduction in seven key modifiable risk factors, including behavioral and lifestyle choices, could prevent 1.3 million AD cases globally. Healthy lifestyle approaches can reduce oxidative stress, produce structural and functional changes in the brain, and also influence the rate of neurogenesis in adult and senescent animal models. However, interventions that improve these have often been disappointing, in part because the impact of each lifestyle behavior on AD risk is relatively small.

This pilot study aims to evaluate how a remote multicomponent lifestyle intervention program improves mood symptoms (chronic stress) and positively impacts biomarkers of vascular health and the autonomic nervous system among forty African American and White patients with MCI.

Conditions

Mild Cognitive Impairment

Keywords

lifestyle intervention; Chronic Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PRISEM Remote

PRISEM Remote is a remote-based lifestyle intervention program in which participants will attend 17 core online sessions via Zoom from the evidence-based Diabetes Prevention Program curriculum with remaining post-core sessions to reinforce strategies and activities introduced in the core program for the duration of 6 months.

Group Type: EXPERIMENTAL

PRISEM Remote

Intervention Type: BEHAVIORAL

Participants will attend 1-hour sessions weekly for 12 weeks (12 sessions) then biweekly for 8 weeks (4 sessions) and 1 session in the last month (1 session). Sessions will be group-based and will cover the following topics: 1) Program Overview, 2) Get Active, 3)Track Activity, 4) Eating Well, 5) Track Food, 6) Get More Active, 7) Energy In, Energy Out, 8) Eating to Support Health Goals, 9) Manage Stress, 10) Eat Well Away From Home, 11) Managing Triggers, 12) How to Stay Active, 13) Take Charge of Thoughts, 14) Get Back on Track, 15) Get Support (from friends and family), and 16) Staying Motivated. Sessions will include a brief presentation of the topic, followed by an introduction to tools and strategies to practice. This is a facilitated program with participants "driving" the direction and acting as peer support to one another.

Interventions

PRISEM Remote

Participants will attend 1-hour sessions weekly for 12 weeks (12 sessions) then biweekly for 8 weeks (4 sessions) and 1 session in the last month (1 session). Sessions will be group-based and will cover the following topics: 1) Program Overview, 2) Get Active, 3)Track Activity, 4) Eating Well, 5) Track Food, 6) Get More Active, 7) Energy In, Energy Out, 8) Eating to Support Health Goals, 9) Manage Stress, 10) Eat Well Away From Home, 11) Managing Triggers, 12) How to Stay Active, 13) Take Charge of Thoughts, 14) Get Back on Track, 15) Get Support (from friends and family), and 16) Staying Motivated. Sessions will include a brief presentation of the topic, followed by an introduction to tools and strategies to practice. This is a facilitated program with participants "driving" the direction and acting as peer support to one another.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age: 50 years or older
• Fluency in English
• African American or White
• MCI will be defined as subjective memory complaints with a Montreal Cognitive Assessment (MoCA) 19- 25
• Prior diagnosis of MCI
• Participants would be sedentary at baseline (self-report of <30 minutes of structured physical activity <3 times per week in the last 6 months) and have poor Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet scores (using the MIND diet screener)

Exclusion Criteria

• Dementia diagnosis or reversible causes of dementia (e.g., if the patient has hypothyroidism or low vitamin B12 that is contributing to the subject's cognitive impairment)
• Active medical or psychiatric diseases that in the judgment of the investigator would affect the safety of the subject or scientific integrity of the study (e.g., actively manic patient)
• Uncontrolled medical conditions, such as congestive heart failure, reflected by poor exercise tolerance and shortness of breath
• Any physical ailment, such as stroke with residual impairment, that is a barrier to performing study procedures and attending sessions
• History of brain lesions, stroke, or major head trauma in the past year
• Those who are unable to demonstrate that they understood the details of the study (i.e., lack of decisional- capacity to consent) or linguistic limitations
• Pregnant women, prisoners, and adults unable to consent

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ambar Kulshreshtha

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ambar Kulshreshtha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Goizueta Alzheimer's Disease Research Center (GADRC)

Atlanta, Georgia, United States

Emory Dunwoody Clinic

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1K23AG066931-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P011143

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00004811

Identifier Type: -

Identifier Source: org_study_id