Mindful Walking Program for Older African Americans

NCT ID: NCT06085196

Last Updated: 2023-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-16

Study Completion Date

2025-09-30

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.

Conditions

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Cognitive Function Aging Well Behavior, Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Mindful walking

Complete a 24-session outdoor mindful walking intervention over 3 months

Group Type EXPERIMENTAL

Mindful walking activity

Intervention Type BEHAVIORAL

Participate in 24 sessions of outdoor mindful walking on a local walking trail over three months

Delayed mindful walking group

Option to complete a delayed 24-session mindful walking

Group Type OTHER

Mindful walking activity

Intervention Type BEHAVIORAL

Participate in 24 sessions of outdoor mindful walking on a local walking trail over three months

Interventions

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Mindful walking activity

Participate in 24 sessions of outdoor mindful walking on a local walking trail over three months

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. African American ages 60 and above
2. Mild symptoms of cognitive decline or MCI
3. Physically inactive or insufficiently active (based on the 2018 US guidelines)
4. Adequate hearing and visual ability to complete study tasks and assessments
5. English proficiency
6. Medically stable with or without medication
7. Capable of providing informed consent
8. Willing to be randomized to one of the two groups

Exclusion Criteria

1. Clinical diagnosis of ADRD or other brain abnormalities (e.g., strokes, epilepsy, Parkinson's disease
2. Clinical diagnosis of psychiatric disorders (i.e., depression, post-traumatic stress disorder, bipolar disorder)
3. 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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Chih-Hsiang Yang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chih-Hsiang "Jason" Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

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University of South Carolina

Columbia, South Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chih-Hsiang "Jason" Yang, PhD

Role: CONTACT

803-777-1025

Laura Phillips, B.S.

Role: CONTACT

4848959788

References

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Yang CH, Lee J, Wilcox S, Rudisill AC, Friedman DB, Hakun JG, Neils-Strunjas J, Wei J, Miller MC, Byers MD. Implementation and evaluation of a community-based mindful walking randomized controlled trial to sustain cognitive health in older African Americans at risk for dementia. BMC Geriatr. 2024 Jul 4;24(1):579. doi: 10.1186/s12877-024-05090-2.

Reference Type DERIVED
PMID: 38965464 (View on PubMed)

Other Identifiers

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Pro00123487

Identifier Type: -

Identifier Source: org_study_id

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