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Old AgeiSTEP-2NCT07629739

Inspiring Seniors Towards Exercise Promotion - 2

A study testing Exercise intervention with RAS (EX+RAS) and Exercise intervention without RAS (EX) in people with Old Age, run by Emory University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Older adults' low adherence to the national physical activity guidelines may stem from a failure to increase positive affective responses to exercise (e.g., enjoyment). Exercising with personalized, tempo-synchronous music playlists has shown promising effects on physical activity promotion in midlife-to-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
Old Age
What is being tested?
Exercise intervention with RAS (EX+RAS) and Exercise intervention without RAS (EX)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
26 May 2026to 31 Aug 2028
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

  • Adults over 65 years old.
  • Ambulatory without pain or the use of assisted walking devices.
  • Able to speak and read English.
  • Healthy enough to exercise at moderate intensity with or without medical clearance by a primary care physician.
  • Living in the community for the duration of the study (9-10 months).
  • Having a reliable means of transportation.
  • Having a safe place at home or at a residential area (at least 6 feet by 6 feet of open space) for unsupervised exercise training.
  • Being low-active (< 90 min/week of MAT and < 2 days/week of ST for the last 3 months).

Who cannot join

  • Diagnosed progressive, neurodegenerative, or severe central nervous system disorders (e.g., Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, or history of stroke with residual deficits) that significantly impair cognitive function, motor skills, or the ability to engage in independent exercise training over moderate intensity
  • Participants with a history of episodic or peripheral neurological conditions (such as neuralgia or migraines) or stable cardiovascular/metabolic conditions may be included if they receive formal written medical clearance from their primary care physician or treating specialist, confirming it is safe for them to engage in unsupervised exercise training at moderate intensity.
  • Known exercise contraindications (uncontrolled hypertension, joint problems, diabetes, metabolic conditions, etc.), determined by self-report on the PAR-Q+.
  • Current or upcoming cancer treatment, determined by self-report on the PAR-Q+.
  • Stroke or neural impairment in the past 6 months, as self-reported on the PAR-Q+.
  • Hip/knee/spinal fracture or surgery in the past 6 months, determined by self-report on the ACSM Health Screening Questionnaire.
Show all 18Show fewer
  • Unable or unwilling to attend intervention classes, as determined by phone screening.
  • Currently participating in any other exercise or fitness-related research study, determined by phone screening.
  • Use of medications for cognitive impairment, as self-reported on the medication survey.
  • Initiation or change in dosage of psychiatric medications (e.g., antidepressants, anxiolytics) within the past 8 weeks; participants must be on a stable dose for at least 2 months before enrollment and intend to maintain this dose throughout the 8-month study period.
  • Self-report regularly drinking > 14 alcoholic beverages a week or current illicit drug use, determined by self-report to screening surveys.
  • Current regular or hazardous use of illicit substances, or misuse of prescription medications, that occurs on a weekly or more frequent basis, or any substance use that, in the judgment of the investigator, would systematically confound weekly affective assessments or compromise safety during unsupervised exercise training, determined by self-report to screening surveys
  • Cannot ambulate without a walker/cane, assessed in the American College of Sports Medicine (ACSM) Health Screening Questionnaire
  • Having cognitive impairment, determined by the Montreal Cognitive Assessment (MoCA) BLIND < 17.
  • Meet the threshold for clinical depression, determined by the Center for Epidemiological Studies Depression Scale Revised (CESD-R).
  • Uncorrected hearing or visual impairments, self-reported on the Health History Questionnaire.
  • Unable to understand the study procedure.
  • One of the household members is participating in this study, as self-reported during phone screening.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kaetlin Marsh, MPH contact

404-544-2381

kaetlin.marsh@emory.edu

United States1 site, 1 recruiting
  • Emory University

    Atlanta, Georgia, 30329

    Recruiting

Other trials in United States

About this study

Older adults' low adherence to the national physical activity guidelines may stem from a failure to increase positive affective responses to exercise (e.g., enjoyment). Exercising with personalized, tempo-synchronous music playlists has shown promising effects on physical activity promotion in midlife-to-older adults during a cardiac rehab program. The purpose of this study is to determine how personalized, tempo-synchronous music playlists called rhythmic auditory stimulation (RAS) influence exercise behavior change and affective responses to exercise over 8 months among community-dwelling, sedentary older adults.

Read the detailed description

Participants 65 years and older will be offered an exercise program for six months, either with or without RAS. The exercise program is based on the national physical activity guidelines for older adults and designed to train participants to independently engage in strength training and moderate-intensity aerobic training through the gradual withdrawal of supervised exercise classes (2 days/week for 3 months and 1 day/week for an additional 3 months). At baseline, every month during the 6-month intervention, and 2-month post-intervention follow-up, we assess weekly volume of physical activity (primary outcome) using a hip-worn activity tracker and affective attitude toward physical activity (mechanistic outcome) through text-message-based ecological momentary assessment (EMA). Before and after the 6-month intervention, participants will complete a lab visit for the assessment of cognitive, vascular, and physical functioning, fitness, anthropometry, and quality of life.

Conditions
Old Age
Being tested
Exercise intervention with RAS (EX+RAS), Exercise intervention without RAS (EX)
Keywords
Physical Activity, Exercise, Music, Cognitive decline prevention
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise intervention with RAS (EX+RAS)Behavioural

    Supervised exercise sessions will be led by an exercise specialist at an open-floor gym. All participants will be asked to attend a supervised group exercise session for moderate aerobic training (MAT) for 15-40 minutes/day and muscle-strengthening training (ST) for 15-20 minutes/day for 2 days/week for the first 3 months, while being encouraged to independently perform MAT on up to 3 more days/week. Then, the same training session will be offered for 1 day/week for an additional 3 months while encouraging participants to independently perform ST on 1 more day of the week and MAT up to 4 more days of the week. Participants will be instructed on set and track exercise goals, supplemented with a series of behavioral supports during the 6-month intervention and until a 2-month post-intervention follow-up.

  • Exercise intervention without RAS (EX)Behavioural

    Supervised exercise sessions will be led by an exercise specialist at an open-floor gym. All participants will be asked to attend a supervised group exercise session for moderate aerobic training (MAT) for 15-40 minutes/day and muscle-strengthening training (ST) for 15-20 minutes/day for 2 days/week for the first 3 months, while being encouraged to independently perform MAT on up to 3 more days/week. Then, the same training session will be offered for 1 day/week for an additional 3 months while encouraging participants to independently perform ST on 1 more day of the week and MAT up to 4 more days of the week. Participants will be instructed on set and track exercise goals, supplemented with a series of behavioral supports during the 6-month intervention and until a 2-month post-intervention follow-up.

Study groups in NCT07629739
Study groupRoleWhat they receive
Exercise intervention with RAS (EX+RAS)ExperimentalParticipants will be randomized to an exercise intervention with RAS (EX+RAS) over 6 months, offering the exercise prescription to foster independent adherence to the Physical Activity guidelines (PAG) through the gradual withdrawal of supervised training. This group will be provided with RAS playlists and trained to use them for their exercise sessions.
Receives: Behavioral: Exercise intervention with RAS (EX+RAS)
Exercise intervention without RAS (EX)Active comparatorParticipants will be randomized to an exercise intervention (EX) over 6 months, offering the same exercise prescription as the experimental group, to foster independent adherence to the PAG through the gradual withdrawal of supervised training. This group will not be provided with any RAS playlists to accompany their exercise.
Receives: Behavioral: Exercise intervention without RAS (EX)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weekly volume of light, moderate, and vigorous physical activity as assessed by ActiGraph

    Duration, intensity, and frequency of physical activity will be assessed using a waist-worn accelerometer.

    Measured: 7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6 (during intervention) and month 8 (2 months post-intervention)

  2. Daily duration of aerobic and strenght training as recorded on an Exercise Log

    Self-reported daily duration and types of physical activity will be self-reported on an exercise log.

    Measured: During month 1, 2, 3, 4, 5, 6, 7 (during the intervention) and month 8 (2 months post - intervention until 2-month post-intervention)

  3. Affective response to exercise measured by the single-item Feeling Scale (FS)

    The single-item Feeling Scale (FS) will be used to measure affective responses to physical activity as assessed by Ecological Momentary Assessment (EMA). How are you feeling right now? with 11-point rating scale scores ranging from -5 to +5, with labels -5 = very bad, -3 = bad, -1 = somewhat bad, 0 = neutral, +1 = somewhat good, +3 = good, and +5 = very good.

    Measured: For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention)

Secondary outcomes (28)
  1. Perceived exertion measured by the Borg's Rating of Perceived Exertion (RPE) scale

    Borg's Rating of Perceived Exertion (RPE) scale will be used to assess perceived exertion during physical activity as assessed by Ecological Momentary Assessment (EMA). Scores range from 6 to 20, with verbal anchors of 7 = very, very light, 9 = very light, 11 = fairly light, 13 = somewhat hard, 15 = hard, 17 = very hard, and 19 = very, very hard.

    Measured: For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention)

  2. Subjective cognitive decline measured by the Cognitive Change Index (CCI-12)

    The Cognitive Change Index (CCI-12) is a 12-item questionnaire assessing self or informant-perceived decline in episodic memory over the past 5 years. It uses a 5-point Likert scale (1=no change, 5=much worse), with higher total scores (range 12-60) indicating greater perceived decline. It acts as a marker for dementia risk, subjective cognitive decline (SCD), and early Alzheimer's. The CCI-12 ranges from 12 to 60. Higher scores signify greater perceived decline.

    Measured: At pre-test (before the intervention) and 6 weeks post-intervention

  3. Exercise motivation measured by the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3)

    The Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) is a 19 to 24-item tool (commonly 23-24 items) used to assess motivation for physical activity based on Self-Determination Theory. It measures six types of motivation, ranging from not at all motivated to intrinsically motivated,. Likert Scale Range: 0 to 4 (0 = "Not true for me", 4 = "Very true for me"). Higher average scores (closer to 4) indicate that a particular regulation style is a strong reason for exercising.

    Measured: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)

  4. Affective attitude toward physical activity measured by the Physical Activity Enjoyment Scale (PACES)

    Physical Activity Enjoyment Scale (PACES) to assess affective attitude toward PA. Self-reported affective states relative to physical activity. The Physical Activity Enjoyment Scale has 18 items on a 7-point Likert scale, and the total score ranges from 18 to 126. A total score of 63 can be used to distinguish between enjoyment (>63) and lack of enjoyment (<63).

    Measured: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)

  5. Individual confidence in regular exercise measured by the Self-Efficacy for Exercise Scale (SEE)

    Self-Efficacy for Exercise Scale (SEE) is a self-report tool used to measure an individual's confidence in their ability to perform exercises regularly (e.g., 3 times per week for 20+ minutes) despite common barriers. The scale consists of 9 items. Scale: Each item is rated on an 11-point Likert scale ranging from 0 (Not Confident) to 10 (Very Confident). Minimum Score: 0 (representing zero confidence). Maximum Score: 90 (representing maximum confidence).

    Total Score Calculation: The total score is calculated by summing the responses to all 9 items. A higher total score indicates higher self-efficacy for exercise.

    0-30: Low self-efficacy (low confidence in overcoming barriers to exercise). 31-60: Moderate self-efficacy. 61-90: High self-efficacy (high confidence in maintaining an exercise routine).

    Measured: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)

  6. Individual barriers in regular exercise measured by Barriers to Being Active survey (BBA)

    The Barriers to Being Active (BBA) survey is a 21-item questionnaire developed by the Centers for Disease Control and Prevention (CDC) to identify personal obstacles to exercise. It measures seven distinct categories of barriers, with each category containing 3 items. Each of the 21 questions is rated on a 4-point Likert scale: Very likely (3 points), Somewhat likely (2 points), Somewhat unlikely (1 point), Very unlikely (0 points). Since there are 3 questions per category, the minimum score is 0, and the maximum score is 9 per barrier. The minimum total score is 0, and the maximum total score is 63 (21 items × 3 points). Significant Barrier: A score of 5 or higher in any of the seven categories indicates that it is an important barrier to overcome. Low Barrier: A score below 5 indicates the barrier is less significant.

    Measured: Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)

  7. Physical activity and sedentary behaviors measured by Physical and Sedentary Behaviour Questionnaire (PASB-Q)

    The Physical and Sedentary Behaviour Questionnaire (PASB-Q) is a tool used to assess an adult's typical weekly physical activity, muscle strengthening, and sedentary habits. It is not a single standardized 0-100 score, but rather a questionnaire that measures specific behaviors and can be used to gauge whether an individual meets physical activity guidelines. The questionnaire measures several aspects of physical activity. There is no set "maximum" score, as it measures frequency and duration, but the "minimum" is 0. It calculates the total minutes of moderate-to-vigorous aerobic physical activity per week. Minutes/day = Total Minutes/Week. Interpretation: Higher minutes per week indicate higher activity levels.

    Measured: At pre-test (before the intervention) and post-test within 6 weeks after the intervention

  8. Health-related quality of life measured by RAND 36-item Health Survey (RAND-36)

    RAND 36-item Health Survey (RAND-36) to assess health-related quality of life. The RAND 36-Item Short-Form Health Survey Scale has 36 items for self-report, takes 10-15 minutes to complete, and measures health-related quality of life with a score ranging from 0 to 100, where 0 indicates the lowest possible health state (worst health), and 100 indicates the highest possible health state (best health). Higher scores always represent better health status.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  9. Sleep disturbance measured by the Pittsburgh Sleep Quality Index (PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire used to evaluate sleep quality over a one-month interval. It measures seven components of sleep, with a total global score ranging from 0 to 21. Minimum Score: 0 (Indicates no difficulty/excellent sleep quality).Maximum Score: 21 (Indicates severe difficulties in all areas/very poor sleep quality). Higher Score = Worse Sleep: A higher total score indicates poorer sleep quality. Scoring of 5: "Good" sleeper (low level of sleep disturbance) and > 5: "Poor" sleeper (indicates significant, relevant sleep disturbances)

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  10. Depression measured by the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)

    The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) is a 20-item self-report questionnaire designed to measure the frequency and severity of depressive symptoms over the past two weeks. It is used to identify individuals who may need a further clinical evaluation for depression. Minimum Score (0): Indicates that the individual experienced almost no depressive symptoms, or that symptoms were present for less than one day, over the past two weeks. Maximum Score (80): Indicates high frequency and severity, suggesting all 20 symptoms were present nearly every day for the past two weeks. Total Score Range: The CESD-R uses a 5-point scale (0 to 4 per item), resulting in a total range of 0 to 80. A total score of >=16 or >= 17 generally indicates a risk for clinical depression or significant depressive symptoms.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  11. Perceived stress measured by the NIH Toolbox Perceived Stress Scale (PSS).

    The NIH Toolbox Perceived Stress Scale (PSS) is a 10-item self-report questionnaire designed to measure how unpredictable, uncontrollable, and overloaded a person finds their life to be over the past month. The PSS is part of the NIH Toolbox Emotion Battery. Minimum Score (0): Indicates no perceived stress. Maximum Score (40): Indicates very high perceived stress. Calculation: Responses are scored on a scale of 0 (Never) to 4 (Very Often). Four positive items are reversed (0=4, 1=3, 2=2, 3=1, 4=0) before summing all 10 items for a total score.

    0-13 (Low Stress): Below-average stress, generally feel in control. 14-26 (Moderate Stress): Average stress level, manageable but may warrant attention.

    27-40 (High Stress): Elevated, high stress, often associated with poorer health outcomes.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  12. Arterial fitness (carotid-femoral pulse wave velocity) as measured by the SphygmoCor XCEL system

    The SphygmoCor XCEL system provides measurements on pulse wave velocity, which will serve as the outcome of interest in arterial fitness. It is measured in units of meters per second, at which blood pressure waves travel through the circulatory system.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  13. Central aortic blood pressure (systolic and diastolic, mmHg) as measured by the SphygmoCor XCEL system

    Central aortic pressure measures blood pressure directly at the root of the aorta, and is measured in units of millimeters of mercury (mmHg).

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  14. Body Weight

    Measurements will be taken using the InBody380 scan.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  15. Skeletal muscle mass

    Skeletal muscle mass will be measured using the InBody380 scan.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  16. Body fat percentage

    Body fat percentage (percent body fat) will be measured using the InBody380 scan.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  17. Music-related reward experiences measured by the Barcelona Music Reward Questionnaire (BMRQ) to assess music-related reward experiences

    The Barcelona Music Reward Questionnaire (BMRQ) assesses music-related reward experiences. It consists of 20 items rated from 1 (completely disagree) to 5 (completely agree), with scores ranging from 0 to 100.

    Musical Anhedonia (Low): <= 65. These individuals derive little to no pleasure from music despite having normal hearing and cognitive function.

    Average/Normal Reward: 66 - 86. The majority of the population falls within this middle range.

    Hyperhedonia (High): >= 87. These individuals experience unusually strong emotional or physical responses to music.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  18. Sagittal abdominal diameter

    Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  19. Waist circumference

    Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  20. Hip circumference

    Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  21. Leg circumference

    Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  22. The auditory stimulation score

    Auditory stimulation score as assessed by a 10-item custom-developed Playlist Rating survey Developed by the research team, this 10-item survey assesses the extent to which audio and video playlists motivate individuals in strength and aerobic training. Items are scored on a Likert-based scale (1=Strongly disagree, 7=Strongly agree). Scores are stratified by method of playlist administration (i.e., audio and video) and then summed, where higher scores represent higher levels of auditory stimulation. The total score ranges from 5 to 35 for aerobic and strength training, with higher scores indicating greater auditory stimulation.

    Measured: During month 3 and 6 (during intervention) and 8 months (2 months post-intervention)

  23. Gait speed at normal and brisk pace (meters/second) as assessed by the 10-Meter Walk Test (10MWT)

    The 10-meter walk test (10MWT) assesses gait speed by timing a patient walking a 6-meter distance, usually within a 10-meter path to allow for acceleration/deceleration. It is a standardized assessment for gait by measuring the time taken at the 2m and 8m markers during the timed, steady-state portion. This outcome measure reports gait speed in meters per second (m/s) at normal and brisk pace.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  24. Aerobic fitness as assessed by the total distance walked in 6-minute walk test

    The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  25. Hand Grip Strength

    Hand Grip Strength as measured by a Jamar hand dynamometer. The squeeze power in kilograms is measured by a handheld Jamar dynamometer.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  26. The progress of balance as assessed by 4-Stage Balance Test

    Standing balance (time held, in seconds) as assessed by the 4-Stage Balance Test.

    The duration in seconds of maintaining 4 difference postures.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

  27. Lower-body strength as assessed by 30-Second Sit-to-Stand test

    The number of sit-to-stand maneuvers completed in 30 seconds.

    Measured: At pre-test (before the intervention) and post-test, within 6 weeks after the intervention

  28. The progress of balance, sit-to-stand, and walking as assessed by Timed Up and Go test

    The time taken to complete a Timed Up and Go test is an indicator of fall risks.

    Measured: Pre-test (before the intervention) and post-test within 6 weeks after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start26 May 2026
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

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
Participant
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07629739
Sponsor's protocol ID
2025P011936
Other IDs
R33AG084479
Acronym
iSTEP-2
Status last verified
Jul 2026
First submitted
14 May 2026
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Researchers will share individual deidentified participant data that underlie the results reported from this trial (text, tables, figures, and appendices).

Questions about this trial

What is this clinical trial studying?

A study testing Exercise intervention with RAS (EX+RAS) and Exercise intervention without RAS (EX) in people with Old Age, run by Emory 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 8 inclusion and 18 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 23 Jul 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 Kaetlin Marsh, MPH (404-544-2381, kaetlin.marsh@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weekly volume of light, moderate, and vigorous physical activity as assessed by ActiGraph (time frame: 7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6 (during intervention) and month 8 (2 months post-intervention)). The study lists 3 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 23 Jul 2026.

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