Mindful Walking Program for Older African Americans

Study Overview
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Brief Summary
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The goal of this clinical trial is to understand the beneficial role of mindful walking in sustaining cognitive health in African American older adults who have elevated risk of developing neuropsychological diseases. The main question it aims to answer is Does a multi-session mindful walking intervention lead to promising signals of sustaining cognitive health in vulnerable AA older adults? The researchers in this 2-arm randomized controlled trial will compare the mindful walking group with a delayed mindful walking to see if the intervention efficacy is observed at multiple follow-up period.

Detailed Description
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African American (AA) older adults in the U.S. are disproportionally impacted by ADRD compared to other races and ethnicities. Mindful walking integrates two potentially protective factors of ADRD by elevating mindfulness and physical activity (i.e., walking), resulting in a synergistic behavioral strategy that is feasible and safe for older adults. However, the efficacy of using this intervention for cognitive health outcomes has not been tested using experimental designs. This study is a community-based, mindful walking randomized controlled trial to examine its efficacy on cognitive and other health outcomes in ADRD at-risk, AA older adults. This study will recruit 114 older adults (ages 60+ years) with elevated risk of developing ADRD from the Midlands region of South Carolina. Older adults were randomly assigned to participate in 24 sessions of mindful walking or a delayed mindful walking group (n=57 in each group). The study outcomes include various key brain health determinants, including cognitive function, quality of life, psychological well-being, physical activity, mindfulness, sleep, and overall health status. Participants in both groups follow identical measurement protocol of at baseline, 12 weeks, 18 weeks, and 24 weeks. The outcome measures are administered in the lab and in everyday settings. This study will generate preliminary evidence regarding the effects of mindful walking on sustaining cognition health. It will also inform future large-scale effectiveness trials to validate our study findings. If successful, this mindful walking program can be scaled up as a low-cost and viable lifestyle strategy to promote healthy cognitive aging in diverse older adult populations, including those at greatest risk.

Official Title
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Evaluation of an Outdoor Mindful Walking Program for Sustaining Cognitive Function in Older African Americans at Risk for Dementia

Conditions
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Cognitive Function, Aging Well, Behavior, Health

Intervention / Treatment
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* Behavioral: Mindful walking activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American ages 60 and above Mild symptoms of cognitive decline or MCI Physically inactive or insufficiently active (based on the 2018 US guidelines) Adequate hearing and visual ability to complete study tasks and assessments English proficiency Medically stable with or without medication Capable of providing informed consent Willing to be randomized to one of the two groups Exclusion Criteria: Clinical diagnosis of ADRD or other brain abnormalities (e.g., strokes, epilepsy, Parkinson's disease Clinical diagnosis of psychiatric disorders (i.e., depression, post-traumatic stress disorder, bipolar disorder) Unable to walk independently (i.e., need caregiver's assistance) 4) Plan to have surgery or relocate outside the area within the next 6 months 5) Currently participate in other studies involving physical activity, mindfulness, or cognitive training

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful walking<br>Complete a 24-session outdoor mindful walking intervention over 3 months | Behavioral: Mindful walking activity<br>* Participate in 24 sessions of outdoor mindful walking on a local walking trail over three months<br>|
| Other: Delayed mindful walking group<br>Option to complete a delayed 24-session mindful walking | Behavioral: Mindful walking activity<br>* Participate in 24 sessions of outdoor mindful walking on a local walking trail over three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function as assessed by the Montreal Cognitive Assessment (MoCA) | MoCA is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, conceptual thinking, calculations, and orientation. | Baseline, 12,18,24 weeks follow-up | 
| Everyday Cognition as assessed by the NIH Mobile Toolbox | The NIH Mobile Toolbox is a smartphone-based, ultra-brief cognitive assessments to measure different domains of cognition using the smartphone screen. | Baseline, 18, 24 weeks follow-up (4 days each), Weeks 12 and 13 (14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Quality of Life as assessed by the EuroQol 5 dimensions and 5 levels questionnaire | The EuroQol 5 dimensions and 5 levels survey (EQ-5D-5L) is a self-assessed, health related, quality of life questionnaire. The questionnaire measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, ranging from 11111 (best) to 55555 (worst). | Baseline, 12,18,24 weeks follow-up | 
| Subjective Physical Activity Levels as assessed by the CHAMPS (Community Health Activities Model Program for Seniors) questionnaire | The CHAMPS self-report questionnaire assesses weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults | Baseline, 12,18,24 weeks follow-up | 
| Device-based Physical Activity Levels as assessed by the activPAL Accelerometer | The activPAL is a small, slim activity monitor that uses an accelerometer to measure limb position and activity. It's worn on the thigh and uses algorithms to determine body posture, including moving, standing, and sitting. | Weeks 12 and 13 (14 days) | 
| Mindfulness Level as assessed by the Mindfulness Attention Awareness Scale and Five Facet Mindfulness Questionnaire | Use Mindfulness Attention Awareness Scale (MAAS) is a 15-item self-report survey that measures mindfulness in general and in specific day-to-day circumstances. Each MAAS scores can range from 1 to 6. Higher scores indicate greater mindfulness; The Five Facet Mindfulness Questionnaire (FFMQ) has 39 self-reported items. It measures five mindfulness facets, including Observing, Describing, Acting with awareness, Non-judgmental, and Non-reactive. The items are rated on a 5-point Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true). | Baseline, 12,18,24 weeks follow-up | 
| Overall Health Status as assessed by the SF-36 self-report survey | The SF-36 is a 36-item survey that measures eight domains of health status. The survey is designed to capture adult patients' perceptions of their own health and well-being. The score range is 0 to 100. Higher scores indicate better health status. | Baseline, 12,18,24 weeks follow-up | 
| Mobility as assessed by the 10-meter walk test | The 10-meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. | Baseline, 12,18,24 weeks follow-up | 
| Perceived Stress as assessed by the Perceived Stress Scale (PSS-10) | The Perceived Stress Scale (PSS-10) is a 10-item questionnaire that measures psychological stress. The PSS-10 asks respondents to rate statements about their feelings and thoughts. Each question is scored from 0 (never) to 5 (very often) with a total possible score range of 0 to 40. | Baseline, 12,18,24 weeks follow-up | 
| Depressive Symptoms as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D) | The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item questionnaire that measures the severity of depressive symptoms in the general population. The CES-D has a possible range of scores from zero to 60. Higher scores indicate the presence of more symptomatology. | Baseline, 12,18,24 weeks follow-up | 
| Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire that assesses sleep quality and quantity. It has seven components, each rated from 0 (no difficulty) to 3 (severe difficulty). It has a global score range of 0 to 21. Higher scores indicate worse sleep quality. | Baseline, 12,18,24 weeks follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking, Mindfulness, Lifestyle activity