mPATH for Low-income Older Adults

mHealth-Facilitated Physical Activity Toward Health (mPATH) Intervention for Low-Income Older Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Sedentary Time; Cognitive Decline
• Intervention / Treatment: Behavioral: mPATH; Other: Attention Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junxin Li; Phone Number: 4105022608; Email: junxin.li@jhu.edu
• Study Contact Backup: Name: Julianna Kruemmel; Phone Number: 443-692-7169; Email: jkruemm1@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • The Johns Hopkins University, School of Nursing
      • Contact: Junxin Li; Phone Number: 410-502-2608
      • Contact: Julianna Kruemmel; Phone Number: 4436927169; Email: jkruemm1@jh.edu
      • Principal Investigator: Junxin Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mPATH; 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	Behavioral: mPATH; 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.
Active Comparator: Education and Social control; 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	Other: Attention Control; 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.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in episodic memory as assessed by the Cogstate	Episodic memory will be measured by computerized cognitive batteries using Cogstate	Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sleep efficiency as assessed by actigraphy	sleep efficiency will be measured by 7-day actigraph (reported as a percentage)	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Junxin Li, Johns Hopkins University; Study Director: Youngmin Cho, PhD, Johns Hopkins University School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: memory; physical activity; sleep
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders; Motor Activity; Sedentary Behavior
• Other Study ID Numbers: IRB00396390; 1R01AG080613-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: working on it
• IPD Sharing Time Frame: become available after the primary outcome paper published online
• IPD Sharing Access Criteria: with request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No