HealthyI-PASSNCT06896825
Increasing Physical Activity Through Social Support and Stress Resilience
A study testing Self-monitoring in people with Healthy and Subjective Cognitive Decline (SCD), run by Arizona State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn the effects of technology enhancements when combined with basic education, goal-setting, and self-monitoring to increase physical activity among older adults living alone, experiencing subjective cognitive decline, and currently engaging minimal physical activity (60 minutes… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Subjective Cognitive Decline (SCD), Sedentary Behavior
- What is being tested?
- Self-monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2025to Apr 2027
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 years or older
- Living alone and community dwelling
- Engaging in 60 minutes or less per week of self-reported moderate-to-vigorous physical activity at screening (based on Exercise Vital Sign Questionnaire)
- Self-reported decline in cognitive functioning
- Self-reported ownership of/willingness to use a smartphone with an iOS or Android operating system (necessary for participants to track their activity using a wearable activity monitor).
- Able to read and speak in English. We hope to offer the intervention in Spanish in the future; however, currently, the study materials are only available in English, and participation will require ability to read and respond to study materials.
Who cannot join
- Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a physician's note is provided
- Resting blood pressure greater than 200/110 mmHG as assessed at the baseline study assessment (unless a physician's note is provided)
- Plans to relocate out of metropolitan Phoenix, Arizona area in the next 6 months
- Participation in another physical activity, nutrition or weight loss program at time of screening or at any time during the intervention
- Individuals with mild cognitive impairment (MCI), as determined by either a self-report of receiving a diagnosis of MCI from a health care provider or as assessed by the Telephone-Montreal Cognitive Assessment (T-MoCA) at the Baseline Session. A score < 18 is an exclusion criterion.
- Individuals with neurodegenerative (e.g., dementia), developmental (e.g., autism), neurologic (e.g., Parkinson's, epilepsy), or major psychiatric (e.g., bipolar, schizophrenia) diagnoses
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- Being previously prescribed one of the 5 approved Alzheimer's medications, including: Donepezil (Aricept), Rivastigmine (Exelon), Galantamine (Razadyne), Memantine (Namenda), Memantine + Donepezil (Namzaric)
- Score of 9 or higher on the 15-item Geriatric Depression Scale (GDS) at the Baseline Session [scores of 9 and higher are indicative of moderate to severe depression]
- History of stroke
- Incarcerated individuals (i.e., Prisoners)
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
Arizona State University
Phoenix, Arizona, 85004
Molly Maxfield, PhD, 602-496-2311, Molly.Maxfield@asu.edu
Rodney Joseph
About this study
Official title: Increasing Physical Activity Through Social Support and Stress Resilience (I-PASS) Among Older Adults Living Alone With SCD to Lower ADRD Risk
The goal of this clinical trial is to learn the effects of technology enhancements when combined with basic education, goal-setting, and self-monitoring to increase physical activity among older adults living alone, experiencing subjective cognitive decline, and currently engaging minimal physical activity (60 minutes or less of moderate to vigorous physical activity). Further, we will examine key psychosocial mechanisms believed to contribute to successful promotion of physical activity, which include social support and stress resilience.
The primary questions are to determine whether
Read more
- the tech-enhanced condition lead to greater physical activity over time?
- the tech-enhanced condition lead to social support and stress resilience over time?
- social support and stress resilience mediate the relationship between the study condition and physical activity?
All participants will engage in self-monitoring of physical activity, will receive weekly text reminders of their physical activity goals for the week, and will receive basic education about the importance of physical activity, social support, and stress resilience for cognitive, physical, and psychological health. Participants in the tech-enhanced condition will also receive access to a study-specific website and virtual coaching to reinforce the information presented. Researchers will then compare the tech-enhanced condition to the basic education condition to determine the benefits of technology to deliver the intervention materials in order to increase physical activity, social support, and stress resilience.
Participants will:
- Use a Garmin wearable device to monitor their physical activity
- Be randomly assigned to a basic education condition or tech-enhanced condition
- Set achievable goals for weekly physical activity, with incremental increases to achieve 7000 average daily steps by the end of the study
- Respond to surveys to monitor their social support, stress resilience, quality of life, and depression.
The sample has several risk factors for Alzheimer's disease and related dementias: low physical activity, social isolation risk via living alone, and subjective cognitive impairment. Therefore, a long-term goal includes the determination of the intervention's effectiveness at increasing physical activity, social support, and stress resilience to reduce risk for developing dementia.
- Conditions
- Healthy, Subjective Cognitive Decline (SCD), Sedentary Behavior, Social Isolation in Older Adults
- Being tested
- Self-monitoring
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-monitoringBehavioural
All participants will receive a Garmin and use the associated app to monitor their weekly physical activity. Enrolled participants are insufficiently active (engaging in 60 minutes or less of moderate to vigorous physical activity per week) and will receive weekly text messages to incrementally increase physical activity over the course of the study. Goals will be 20% greater than the average daily steps from the previous week, with the ultimate goal of reaching 7000 average daily steps. 7000 average daily steps was selected based on recent findings that it is associated with clinically meaningful health outcomes and being an achievable target for most adults.
| Study group | Role | What they receive |
|---|---|---|
| Tech-enhanced condition | Experimental | Participants in the tech-enhanced condition will receive access to a study specific website (to be developed into an app) and guided use via individual coaching sessions delivered on Zoom. Coaching sessions will align with and reinforce website content, which includes information about the importance of and strategies to increase physical activity, social support, and stress resilience. Receives: Behavioral: Self-monitoring |
| Control condition | Active comparator | Participants in the control condition will receive a study-specific manual containing basic education about the importance of and strategies to increase physical activity, social support, and stress resilience. Receives: Behavioral: Self-monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity as measured by average daily steps (and minutes of moderate to vigorous physical activity) from baseline to 3-months
ActiGraph GT9X Link Activity monitors worn on non-dominant wrist during waking hours 7 consecutive days will provide objective measure of 1) average daily steps and 2) moderate to vigorous activity prior to and after the intervention. GTX9X data (collected in raw format) will be aggregated for analysis to epochs of 60 secs or less for comparability to other studies.
Measured: Assessed at baseline and 3-months
Change in self-reported physical activity
Participants will complete an abbreviated 7-Day Physical Activity Recall interview, which assesses self-reported moderate to vigorous physical activity.
Measured: Assessed at baseline and 3-months
Secondary outcomes (8)
Objective Stress Resilience
At baseline and 3 months, participants will have blood drawn to assess glial fibrillary acidic protein, an indicator of stress which has also been associated with neurocognitive disorders.
Measured: Assessed at baseline and 3-months
Self-reported stress
The 14-item Perceived Stress Scale, with items rated on a 5 point scale (0 to 4). Sum scores are calculated. Possible values range from minimum of 0 to maximum of 56. Higher scores indicate greater perceived stress.
Measured: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Brief Resilience Scale
The 6-item Brief Resilience Scale assesses ability to recover from or adjust to challenges. Items are rated on a 5 point scale. Mean scores are calculated. Possible scores range from a minimum of 1 to a maximum of 5. Higher scores indicating greater resilience.
Measured: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Social Isolation
The 10-item Lubben Social Network Scale assesses objective size of social network. Items are rated on a 6 point scale. Sum scores are calculated. Possible scores range from a minimum of 0 and maximum of 60. Higher scores indicate larger social network and contacts.
Measured: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Self-reported loneliness
The 3-item UCLA Loneliness scale assesses the feeling of being alone or lacking companionship. Responses range from 1 to 3. Sum scores are calculated. Possible scores range from a minimum of 3 to a maximum of 9. Higher numbers indicate greater perceived loneliness.
Measured: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Depression
Participants will complete the 15-item Geriatric Depression Scale. The items include yes/no responses. Scores will be summed. Possible scores range from a minimum value of 0 to a maximum value of 15. Higher scores indicate greater depression. At eligibility screening, participants must score below 9 on this measure to be included in the study.
Measured: Assessed at screening and after the 3 month intervention
General Anxiety
Participants will complete the 7-item General Anxiety Disorder Questionnaire. Using a 4 point scale (0 to 3), the items assess worry and anxiety over the past two weeks. Mean scores will be calculated. Possible scores range from a minimum score of 0 to a maximum score of 21. Higher scores indicate greater anxiety.
Measured: Assessed at baseline and after the 3 month intervention
Health-related quality of life
Participants will complete the 4-item health-related quality of life assessment. The items assess self-perceived health and days during the past month they had poor physical health or mental health, and the extent to which poor health kept them from doing daily activities. Mean scores will be calculated. Higher scores indicate poorer health-related quality of life.
Measured: Assessed at baseline and after the 3 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start23 Jun 2025
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Arizona State 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Molly Maxfield, Arizona State University
- Investigators
- Molly Maxfield, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896825
- Sponsor's protocol ID
- STUDY00020326
- Other IDs
- 1P30AG086561-01
- Acronym
- I-PASS
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity Through Social Support and Stress Resilience (I-PASS) Among Older Adults Living Alone With SCD to Lower ADRD Risk
- ClinicalTrials.gov ID
- NCT06896825
- Acronym / sponsor ID
- I-PASS / STUDY00020326
- Conditions
- Healthy, Subjective Cognitive Decline (SCD), Sedentary Behavior, Social Isolation in Older Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 26 Mar 2025 (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.
The goal of this clinical trial is to learn the effects of technology enhancements when combined with basic education, goal-setting, and self-monitoring to increase physical activity among older adults living alone, experiencing subjective cognitive decline, and currently engaging minimal physical activity (60 minutes or less of moderate to vigorous physical activity). Further, we will examine key psychosocial mechanisms believed to contribute to successful promotion of physical activity, which include social support and stress resilience.
The primary questions are to determine whether
- the tech-enhanced condition lead to greater physical activity over time?
- the tech-enhanced condition lead to social support and stress resilience over time?
- social support and stress resilience mediate the relationship between the study condition and physical activity?
All participants will engage in self-monitoring of physical activity, will receive weekly text reminders of their physical activity goals for the week, and will receive basic education about the importance of physical activity, social support, and stress resilience for cognitive, physical, and psychological health. Participants in the tech-enhanced condition will also receive access to a study-specific website and virtual coaching to reinforce the information presented. Researchers will then compare the tech-enhanced condition to the basic education condition to determine the benefits of technology to deliver the intervention materials in order to increase physical activity, social support, and stress resilience.
Participants will:
- Use a Garmin wearable device to monitor their physical activity
- Be randomly assigned to a basic education condition or tech-enhanced condition
- Set achievable goals for weekly physical activity, with incremental increases to achieve 7000 average daily steps by the end of the study
- Respond to surveys to monitor their social support, stress resilience, quality of life, and depression.
The sample has several risk factors for Alzheimer's disease and related dementias: low physical activity, social isolation risk via living alone, and subjective cognitive impairment. Therefore, a long-term goal includes the determination of the intervention's effectiveness at increasing physical activity, social support, and stress resilience to reduce risk for developing dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tech-enhanced condition | Experimental | Behavioral: Self-monitoringParticipants in the tech-enhanced condition will receive access to a study specific website (to be developed into an app) and guided use via individual coaching sessions delivered on Zoom. Coaching sessions will align with and reinforce website content, which includes information about the importance of and strategies to increase physical activity, social support, and stress resilience. |
| Control condition | Active comparator | Behavioral: Self-monitoringParticipants in the control condition will receive a study-specific manual containing basic education about the importance of and strategies to increase physical activity, social support, and stress resilience. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 60 years or older
- Living alone and community dwelling
- Engaging in 60 minutes or less per week of self-reported moderate-to-vigorous physical activity at screening (based on Exercise Vital Sign Questionnaire)
- Self-reported decline in cognitive functioning
- Self-reported ownership of/willingness to use a smartphone with an iOS or Android operating system (necessary for participants to track their activity using a wearable activity monitor).
Key exclusion criteria (10 listed)
- Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a physician's note is provided
- Resting blood pressure greater than 200/110 mmHG as assessed at the baseline study assessment (unless a physician's note is provided)
- Plans to relocate out of metropolitan Phoenix, Arizona area in the next 6 months
- Participation in another physical activity, nutrition or weight loss program at time of screening or at any time during the intervention
- Individuals with mild cognitive impairment (MCI), as determined by either a self-report of receiving a diagnosis of MCI from a health care provider or as assessed by the Telephone-Montreal Cognitive Assessment (T-MoCA) at the Baseline Session. A score < 18 is an exclusion criterion.
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 |
|---|---|---|
| Self-monitoringAll participants will receive a Garmin and use the associated app to monitor their weekly physical activity. Enrolled participants are insufficiently active (engaging in 60 minutes or less of moderate to vigorous physical activity per week) and will receive weekly text messages to incrementally increase physical activity over the course of the study. Goals will be 20% greater than the average daily steps from the previous week, with the ultimate goal of reaching 7000 average daily steps. 7000 average daily steps was selected based on recent findings that it is associated with clinically meaningful health outcomes and being an achievable target for most adults. | Behavioural | Control condition, Tech-enhanced condition |
Primary outcome
Change in physical activity as measured by average daily steps (and minutes of moderate to vigorous physical activity) from baseline to 3-months
Time frame: Assessed at baseline and 3-months
ActiGraph GT9X Link Activity monitors worn on non-dominant wrist during waking hours 7 consecutive days will provide objective measure of 1) average daily steps and 2) moderate to vigorous activity prior to and after the intervention. GTX9X data (collected in raw format) will be aggregated for analysis to epochs of 60 secs or less for comparability to other studies.
Change in self-reported physical activity
Time frame: Assessed at baseline and 3-months
Participants will complete an abbreviated 7-Day Physical Activity Recall interview, which assesses self-reported moderate to vigorous physical activity.
8 secondary outcomes
Objective Stress Resilience
Time frame: Assessed at baseline and 3-months
Self-reported stress
Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Brief Resilience Scale
Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Social Isolation
Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Self-reported loneliness
Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Depression
Time frame: Assessed at screening and after the 3 month intervention
General Anxiety
Time frame: Assessed at baseline and after the 3 month intervention
Health-related quality of life
Time frame: Assessed at baseline and after the 3 month intervention
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 29 Jun 2026.
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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.
Molly Maxfield principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-monitoring in people with Healthy and Subjective Cognitive Decline (SCD), run by Arizona State 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 6 inclusion and 10 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 29 Jun 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 Molly Maxfield, PhD (602-496-2311, Molly.Maxfield@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity as measured by average daily steps (and minutes of moderate to vigorous physical activity) from baseline to 3-months (time frame: Assessed at baseline and 3-months). The study lists 2 primary outcomes in all. 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 29 Jun 2026.