PRogram to Improve Stress-levels and Enhance Memory

NCT05845918 | Completed DMC

• 3 other identifiers: STUDY000048111K23AG066931-01A12025P011143
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment

Keywords

lifestyle intervention; Chronic Stress

Outcome Measures

Primary Outcomes (2)

• Feasibility for the PRISEM pilot to collect additional stress and vascular measurements

  Feasibility will be calculated as the percentage of participants who agree to participate and are enrolled according to the target, with a loss to follow-up.

  6 months

• Acceptability for the PRISEM pilot to collect additional stress and vascular measures.

  Acceptability of the PRISEM pilot participants will be assessed using semi-structured interviews regarding vascular and stress measures conducted over the course of the study.

  Baseline, 6 months, and 12 months

Secondary Outcomes (16)

• Perceived Stress Scale (PSS) score

  Baseline, 6 months, and 12 months

• Short Form (SF)-12 Quality of Life (QoL) score

  Baseline, 6 months, and 12 months

• Weight

  Baseline and 6 months

• Body Mass Index (BMI)

  Baseline and 6 months

• Systolic and diastolic blood pressure (BP) measurements

  Baseline and 6 months

Study Arms (1)

PRISEM Remote

EXPERIMENTAL

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.

Behavioral: PRISEM Remote

Interventions

PRISEM Remote 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.

PRISEM Remote

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Emory Goizueta Alzheimer's Disease Research Center (GADRC)

Atlanta, Georgia, 30329, United States

Location

Emory Dunwoody Clinic

Atlanta, Georgia, 30338, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ambar Kulshreshtha, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 6, 2023
• Study Start: February 21, 2023
• Primary Completion: September 22, 2025
• Study Completion: May 1, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The investigators will share deidentified individual participants beginning 9 months and ending 2 years following article publication
• Access Criteria: The investigators will share deidentified individual participant data with researchers who provide a methodologically sound proposal to achieve the aims of the approved proposal. Please direct inquiries to mindandheart@emory.edu

Locations

US (2)