PRogram to Improve Stress-levels and Enhance Memory
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: PRISEM CEPBehavioral: PRISEM Remote
- Registration Number
- NCT05845918
- Lead Sponsor
- Emory University
- 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, 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 been often disappointing, in part because the impact of each lifestyle behavior on AD risk is relatively small.
The aim of this pilot study is to evaluate how a remote multicomponent lifestyle intervention program improves mood symptoms (chronic stress), and positively impacts biomarkers of vascular health and autonomic nervous system among forty African American and White patients with MCI.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PRISEM CEP (in-person) PRISEM CEP The Cognitive Empowerment Program (CEP) is an in-person lifestyle intervention program in which participants participate in individual or group-based activities that address cognitive, physical, social, and functional independence, education, and well-being goals. PRISEM Remote 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.
- Primary Outcome Measures
Name Time Method Feasibility for the PRISEM pilot to collect additional stress and vascular measures in participants in both PRISEM groups 6 months Feasibility will be calculated as the percentage of participants agreeing to participate (n=60) enrolled as per target with a loss to follow up.
Change in the acceptability for the PRISEM pilot to collect additional stress and vascular measures. Baseline, 6 months, and 12 months 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.
- Secondary Outcome Measures
Name Time Method Change in Perceived Stress Scale (PSS) score Baseline, 6 months, and 12 months The questions in the PSS ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all 10 scale items. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Change in the short form (SF)-12 Quality of Life (QoL) score Baseline, 6 months, and 12 months The SF-12 QoL uses two items each to estimate scores for four to eight health concepts (physical functioning, role-physical, role-emotional, and mental health). Scores for the remaining four health concepts (bodily, pain, general health, vitality, and social functioning) are estimated using one item each. The lower the score the more disability.
Change in weight Baseline, 6 months, and 12 months weight (Kg) will be measured at each study timepoint
Change in BMI Baseline, 6 months, and 12 months Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI will be calculated at each study timepoint.
Change in systolic and diastolic blood pressure (BP) measurements Baseline, 6 months, and 12 months Systolic and diastolic blood pressure (SBP and DBP)will be measured at each time point. BP (mmHg) will be assessed by utilizing an automatic sphygmomanometer in which a cuff will be placed on the participant's forearm.
Change in the heart rate variability (HRV). Baseline, 6 months, and 12 months Heart rate variability (HRV) will be measured with an ECG monitor. A validated signal processing code will be used to evaluate these signals for noise and detect the necessary ECG component measures, and when outliers are suspected, a visual inspection will be performed. If any episodes of Atrial fibrillation are detected by the program, they will be confirmed by the study team and excluded. HRV will be examined in 5-minute sliding windows, and the median, 10th percentile, and minimum values will be calculated.
Effect of the multicomponent intervention programs on Pulse Wave Analyses changes. Baseline, 6 months, and 12 months Indices of arterial stiffness and wave reflections will be estimated in the supine position using the Sphygmocor device (Atcor Medical, Australia), which records sequential high-quality pressure waveforms at peripheral pulse sites using a high-fidelity tonometer. Pulse-wave velocity (PWV) measured between carotid and femoral arteries is a regional assessment of aortic stiffness and is the gold standard index of arterial stiffness.
Effect of the multicomponent intervention programs on measures of cognitive executive function tests. Baseline, 6 months, and 12 months Participants will complete several questionnaires that assess executive cognitive function, which are prerequisites to any purposeful and goal-directed action. They allow one to generate plans, and solutions to problems, or organizational structures that guide future action. They rely on working memory, mental flexibility, and retrieval of relevant information from semantic and episodic memory stores.
Trial Locations
- Locations (2)
Emory Goizueta Alzheimer's Disease Research Center (GADRC)
🇺🇸Atlanta, Georgia, United States
Emory Dunwoody Clinic
🇺🇸Atlanta, Georgia, United States