MindWalk Intervention for Older South Asian Caregivers of People With Cognitive Disabilities (CD)

NCT ID: NCT06002919

Last Updated: 2025-03-18

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2025-09-30

Brief Summary

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Older South Asian family caregivers experience elevated psychological stress and limited physical activity (PA) due to caregiving responsibilities and additional factors such as lack of access to services, cultural/linguistic barriers, stigma and discrimination. South Asian family caregivers are especially underserved and are a growing ethnic group in the US. Both PA and cognitive training (CT) have shown to improve cognitive function in older adults who experience cognitive function decline because of psychological stress. However, there are no studies using this approach for this population. We propose a randomized control trial pilot study to address this gap. Driven by a Community Advisory Committee (CAC) we will develop this 12-week mindful walking intervention using a participatory methodology in partnership with UIC's Cognition Behavior and Mindfulness Clinic that combines the PA of walking and the CT through mindfulness. We will recruit fifty participants and will randomly and equally assign 25 people to the intervention and 25 people to the control group. The intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability. The primary aim of the proposed pilot study is to evaluate the feasibility and acceptability of the protocol and intervention implementation. A secondary aim will evaluate the intervention to examine preliminary efficacy in reduction of psychological stress, improvement in cognitive function, increase in physical activity, and increased self-efficacy (self-efficacy for coping with stress, self-efficacy for physical activity, and overall self-efficacy). The findings of this pilot project will provide evidence-based data to support a larger scale study proposal for future funding such as the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) field initiative award, or the National Institute of Health (NIH) Research Project Grant (R21 NIH Exploratory/Developmental Research Grant Award) award, especially National Institute on Aging (NIA) grants.

Detailed Description

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Older family caregivers, ages 45 and older of people with cognitive disabilities often experience high levels of stress and psychological distress which can result in cognitive decline. Both physical activity (PA) and cognitive training (CT) have shown to improve cognitive function in older adults who experience cognitive function decline because of psychological stress. There are some activities such as South Asian martial arts and yoga, that the South Asian community is familiar with, however there seems to be limited research incorporating mindful walking as an activity combining PA and CT. Specifically, mindful walking is a technique to learn to be more present and focused on the here and now while engaged in the physical activity of walking. Older South Asian family caregivers experience elevated psychological stress and limited physical activity due to caregiving responsibilities and additional factors such as lack of access to services, cultural and linguistic barriers, stigma and discrimination. South Asian family caregivers are especially underserved and are a growing ethnic group in the US. However, there are no studies using this approach for this population. We propose a randomized control trial pilot study to address this gap titled MindWalk: A Mindful Walking Intervention for Older South Asian Family Caregivers of People with Cognitive Disabilities with Perceived Psychological Stress. Driven by a Community Advisory Committee (CAC) we will develop this 12-week mindful walking intervention using a participatory research methodology in partnership with UIC's Cognition Behavior and Mindfulness Clinic that combines the physical activity of walking and the cognitive training through mindfulness. We will recruit fifty participants and will randomly and equally assign 25 people to the intervention and 25 people to the control group. The intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability. The primary aim of the proposed pilot study is to evaluate the feasibility and acceptability of the protocol and intervention implementation. A secondary aim will evaluate the intervention to examine preliminary efficacy in reduction of psychological stress, improvement in cognitive function, increase in physical activity, and increased self-efficacy (self-efficacy for coping with stress, self-efficacy for physical activity, and overall self-efficacy). The findings of this pilot project will provide evidence-based data to support a larger scale study proposal for future funding such as the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) field initiative award, or the National Institute of Health (NIH) Research Project Grant (R21 NIH Exploratory/Developmental Research Grant Award) award, especially National Institute on Aging (NIA) grants.

Conditions

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Stress, Psychological Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a a two-arm parallel assignment that involves two groups of participants. One group receives the MindWalk intervention, and the other group is the control group.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MindWalk Intervention

12 week intervention: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability.

Group Type ACTIVE_COMPARATOR

MindWalk Intervention

Intervention Type BEHAVIORAL

The intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability.

Control group

The participants in the control group will be provided with psychoeducation materials on benefits of walking without any components of mindfulness. The control group will receive neutral text messages with identical frequency and amount of messages that do not include motivational content or reminders related to mindful walking. At the end of study, the control group will also be given access to the recorded virtual mindful walking training (this includes the 30 minutes introductory training and the weekly 10-minute mindfulness topics/modules).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MindWalk Intervention

The intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mindful Walking Intervention

Eligibility Criteria

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Inclusion Criteria

* Older South Asian family caregivers (45 years or older) caring for a person with cognitive disability of any age
* Self-reported insufficient physical activity (defined as participating in moderate physical activity less than 60 min/week) and not engaged in mindfulness training
* Self-reporting of experiencing psychological stress;
* Own a smartphone with a data plan or Bluetooth-enabled device (e.g., tablets such as iPad) to sync data from the Fitbit tracker to the Fitbit app and to receive text messages
* Ability to speak, understand, read and write English; ability to provide informed consent

Exclusion Criteria

* Non-South Asian caregivers
* Caregivers less than 45 years old
* Having self-reported sufficient physical activity (defined as participating in moderate physical activity more than 60 min/week) and engaged in some form of mindfulness training
* Not owning a smartphone with a data plan or Bluetooth-enabled device (e.g., tablets such as iPad)
* Mobility limitation
* Taking medications or other behavioral treatment for stress reduction; acute or chronic diseases at baseline
* Inability to understand, speak, read, and write English
* Inability to provide informed consent
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Sumithra Murthy

Visiting Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sumithra Murthy

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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American Association of Retired Asians

Bolingbrook, Illinois, United States

Site Status RECRUITING

Sanjeevani 4U

Buffalo Grove, Illinois, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

Apna Ghar

Chicago, Illinois, United States

Site Status RECRUITING

South Asian American Policy & Research Institute

Chicago, Illinois, United States

Site Status RECRUITING

Metropolitan Asian Family Services

Chicago, Illinois, United States

Site Status RECRUITING

Hamdard Health Alliance

Chicago, Illinois, United States

Site Status RECRUITING

IL Department of Aging

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sumithra Murthy

Role: CONTACT

312-355-1396

Facility Contacts

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Nazneen Saylawala

Role: primary

Promila Kumar

Role: primary

Namratha Kandula

Role: primary

Radhika Sharma

Role: primary

Shobhana Johri Verma

Role: primary

Santosh Kumar

Role: primary

Kiran Siddiqui

Role: primary

Selma D'Souza

Role: primary

Other Identifiers

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P30AG022849

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023-0337

Identifier Type: -

Identifier Source: org_study_id

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