search
Back to results

mPATH for Low-income Older Adults

Primary Purpose

Sedentary Time, Insomnia, Cognitive Decline

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mPATH
Attention Control
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedentary Time focused on measuring physical activity, memory, sleep

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: self-reported difficulty of sleep lack of physical activity/exercise low household income capacity for moderate intensity exercise Exclusion Criteria: untreated sleep apnea severe depression or anxiety dementia history of neurologic or psychiatric disorders, neurodevelopmental impairment, traumatic brain injury current enrollment in another clinical trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    mPATH

    Education and Social control

    Arm Description

    mPATH is a personalized physical activity intervention that includes personalized physical activity plans and training sessions, exercise at home by following personalized exercise videos, and biweekly phone coaching over 24 weeks, supported by wearable devices-enabled mHealth strategies. mHealth strategies and exercise videos will be used to support participant's physical activity during 6-12months

    This attention control group is designed to match the intervention for mPATH's staff-subject interaction duration through monthly home visits in the first 6 months

    Outcomes

    Primary Outcome Measures

    Change in episodic memory as assessed by the Cogstate Alzheimer's Battery
    Episodic memory will be measured by computerized cognitive batteries using the Cogstate Alzheimer's Battery.

    Secondary Outcome Measures

    Change in Sleep efficiency as assessed by actigraphy
    sleep efficiency will be measured by 7-day actigraph (reported as a percentage).

    Full Information

    First Posted
    June 29, 2023
    Last Updated
    June 29, 2023
    Sponsor
    Johns Hopkins University
    Collaborators
    National Institute on Aging (NIA)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05935241
    Brief Title
    mPATH for Low-income Older Adults
    Official Title
    mHealth-Facilitated Physical Activity Toward Health (mPATH) Intervention for Low-Income Older Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2028 (Anticipated)
    Study Completion Date
    December 1, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Although empirical research suggests that physical activity interventions benefit cognition and sleep in older adults in general, the possible benefit of physical activity is understudied in low-income older adults. The study aims to test the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on cognitive function and sleep in low-income older adults.
    Detailed Description
    Low-income older adults (LIOA) are a population at higher risk to develop Alzheimer's disease and related dementias (ADRD) and sleep disturbances. Although empirical research suggests that physical activity interventions benefit cognition and sleep in older adults in general, the possible benefit of physical activity is understudied in LIOA. The growing wearable device and mobile Health (mHealth) provide an innovative approach to deliver individually tailored physical activity interventions at home with flexible schedules to overcome barriers to physical activity in LIOA. In addition, limited research has examined if physical activity interventions impact the individual's Amyloid/Tau/ Neurodegeneration (ATN) Alzheimer's disease biological state and whether physical activity may promote cognition through impacting sleep and AD pathology. This randomized controlled trial is designed to examine the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on cognitive function and sleep in LIOA. mPATH is a personalized physical activity intervention that includes personalized physical activity plans and training sessions, exercise at home by following personalized exercise videos, and biweekly phone coaching over 24 weeks, supported by wearable devices-enabled mHealth strategies. mHealth strategies and exercise videos will be used to support participant's physical activity during 6-12months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sedentary Time, Insomnia, Cognitive Decline
    Keywords
    physical activity, memory, sleep

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    176 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    mPATH
    Arm Type
    Experimental
    Arm Description
    mPATH is a personalized physical activity intervention that includes personalized physical activity plans and training sessions, exercise at home by following personalized exercise videos, and biweekly phone coaching over 24 weeks, supported by wearable devices-enabled mHealth strategies. mHealth strategies and exercise videos will be used to support participant's physical activity during 6-12months
    Arm Title
    Education and Social control
    Arm Type
    Active Comparator
    Arm Description
    This attention control group is designed to match the intervention for mPATH's staff-subject interaction duration through monthly home visits in the first 6 months
    Intervention Type
    Behavioral
    Intervention Name(s)
    mPATH
    Intervention Description
    The active mPATH intervention takes 6 months including (1) The physical activity education session , (2)mHealth learning and practice; (3)Personalized physical activity training, plan, and biweekly phone calls over 24 weeks (4) mHealth strategies to encourage physical activity and facilitate intervention adherence (5) (5) mPATH during 6-12 months: mPATH will be delivered mainly in 24 weeks before the 6-month data collection. During 6-12 months, the participants will have access to study mHealth strategies, and exercise videos. No additional physical activity training by staff will be supported.
    Intervention Type
    Other
    Intervention Name(s)
    Attention Control
    Intervention Description
    A registered nurse from the study team will provide 6 monthly home visit (approximately 55-60 minutes each) to provide physical activity education, physical activity safety at home evaluation, feedback, and social activity (meaningful or enjoyable activities as identified by the participants, such as playing cards, doing arts and crafts, listening to music, talking about life history, etc.).
    Primary Outcome Measure Information:
    Title
    Change in episodic memory as assessed by the Cogstate Alzheimer's Battery
    Description
    Episodic memory will be measured by computerized cognitive batteries using the Cogstate Alzheimer's Battery.
    Time Frame
    Baseline, 6 months, 12 months
    Secondary Outcome Measure Information:
    Title
    Change in Sleep efficiency as assessed by actigraphy
    Description
    sleep efficiency will be measured by 7-day actigraph (reported as a percentage).
    Time Frame
    Baseline, 6 months, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: self-reported difficulty of sleep lack of physical activity/exercise low household income capacity for moderate intensity exercise Exclusion Criteria: untreated sleep apnea severe depression or anxiety dementia history of neurologic or psychiatric disorders, neurodevelopmental impairment, traumatic brain injury current enrollment in another clinical trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junxin Li
    Phone
    4105022608
    Email
    junxin.li@jhu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashley Grove
    Phone
    443-692-7169
    Email
    agrove5@jh.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Junxin Li
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    working on it
    IPD Sharing Time Frame
    become available after the primary outcome paper published online
    IPD Sharing Access Criteria
    with request

    Learn more about this trial

    mPATH for Low-income Older Adults

    We'll reach out to this number within 24 hrs