Sedentary TimeNCT05935241
mPATH for Low-income Older Adults
A study testing mPATH in people with Sedentary Time and Insomnia, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Time, Insomnia, Cognitive Decline
- What is being tested?
- mPATH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- self-reported difficulty of sleep
- lack of physical activity/exercise
- low household income
- capacity for moderate intensity exercise
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Johns Hopkins University, School of Nursing
Baltimore, Maryland, 21205
Junxin Li, 410-502-2608
Julianna Kruemmel, 4436927169, jkruemm1@jh.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Sedentary Time, Insomnia, Cognitive Decline
- Being tested
- mPATH, Attention Control
- Keywords
- physical activity, memory, sleep
- Medical subject headings
- Sedentary Behavior, Sleep Initiation and Maintenance Disorders, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mPATHBehavioural
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.
Attention ControlOther
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.).
| Study group | Role | What they receive |
|---|---|---|
| mPATH | Experimental | 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 Receives: Behavioral: mPATH |
| Education and Social control | Active comparator | 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 Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in episodic memory as assessed by the Cogstate
Episodic memory will be measured by computerized cognitive batteries using Cogstate
Measured: Baseline, 6 months, 12 months
Secondary outcomes (1)
Change in Sleep efficiency as assessed by actigraphy
sleep efficiency will be measured by 7-day actigraph (reported as a percentage)
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start30 May 2024
- Primary completion31 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary TimeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Junxin Li, Principal investigator, Johns Hopkins UniversityYoungmin Cho, PhD, Study director, Johns Hopkins University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935241
- Sponsor's protocol ID
- IRB00396390
- Other IDs
- 1R01AG080613-01A1
- Status last verified
- Apr 2026
- First submitted
- 29 Jun 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: working on it
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth-Facilitated Physical Activity Toward Health (mPATH) Intervention for Low-Income Older Adults
- ClinicalTrials.gov ID
- NCT05935241
- Acronym / sponsor ID
- IRB00396390
- Conditions
- Sedentary Time, Insomnia, Cognitive Decline
- Keywords
- physical activity, memory, sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mPATH | Experimental | Behavioral: mPATHmPATH 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 |
| Education and Social control | Active comparator | Other: Attention ControlThis 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- self-reported difficulty of sleep
- lack of physical activity/exercise
- low household income
- capacity for moderate intensity exercise
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mPATHThe 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. | Behavioural | mPATH |
| Attention ControlA 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.). | Other | Education and Social control |
Primary outcome
Change in episodic memory as assessed by the Cogstate
Time frame: Baseline, 6 months, 12 months
Episodic memory will be measured by computerized cognitive batteries using Cogstate
1 secondary outcome
Change in Sleep efficiency as assessed by actigraphy
Time frame: Baseline, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. working on it
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junxin Li principal investigator
Johns Hopkins University
Youngmin Cho, PhD study director
Johns Hopkins University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mPATH in people with Sedentary Time and Insomnia, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junxin Li (4105022608, junxin.li@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in episodic memory as assessed by the Cogstate (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.