Mindful Walking Program for Older African Americans

NCT06085196 | Unknown

• 1 other identifier: Pro00123487
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Function; Aging Well; Behavior, Health

Keywords

Walking; Mindfulness; Lifestyle activity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Perceived Quality of Life as assessed by the EuroQol 5 dimensions and 5 levels questionnaire

  Baseline, 12,18,24 weeks follow-up

• Subjective Physical Activity Levels as assessed by the CHAMPS (Community Health Activities Model Program for Seniors) questionnaire

  Baseline, 12,18,24 weeks follow-up

• Device-based Physical Activity Levels as assessed by the activPAL Accelerometer

  Weeks 12 and 13 (14 days)

• Mindfulness Level as assessed by the Mindfulness Attention Awareness Scale and Five Facet Mindfulness Questionnaire

  Baseline, 12,18,24 weeks follow-up

• Overall Health Status as assessed by the SF-36 self-report survey

  Baseline, 12,18,24 weeks follow-up

Other Outcomes (10)

• Height as measured from the top of the person's head to the heel using digital stadiometer

  Baseline

• Weight as measured using a digital floor scale

  Baseline

• Body Mass Index (BMI) as calculated by the height and weight measures

  Baseline

Study Arms (2)

Mindful walking

EXPERIMENTAL

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

Behavioral: Mindful walking activity

Delayed mindful walking group

OTHER

Option to complete a delayed 24-session mindful walking

Behavioral: Mindful walking activity

Interventions

Mindful walking activity BEHAVIORAL

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

Delayed mindful walking group; Mindful walking

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \) Currently participate in other studies involving physical activity, mindfulness, or cognitive training

Sponsors & Collaborators

• University of South Carolina: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 38965464 DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chih-Hsiang "Jason" Yang, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-Hsiang "Jason" Yang, PhD

CONTACT

803-777-1025; cy11@mailbox.sc.edu

Laura Phillips, B.S.

CONTACT

4848959788; lp32@email.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 16, 2023
• Study Start: May 16, 2023
• Primary Completion: June 15, 2024
• Study Completion: September 30, 2025
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

US (1)