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Physical ActivityPhase 2NCT06337708

Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women

A Phase 2 study testing Smart Walk and Fitbit in people with Physical Activity and Exercise, run by Arizona State 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

The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women. Read more about this study

Who is it for?
Ages 24 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Physical Activity, Exercise, Heart Diseases
What is being tested?
Smart Walk and Fitbit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteUnited States
Study dates
8 Apr 2024to 31 Mar 2029
Phase
Phase 2
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 24 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Self-reported African American/Black female
  • Aged of 24-65 years
  • Insufficiently Active (< 60 minutes of moderate-to-vigorous physical activity per week as measured by Exercise Vital Sign Questionnaire)
  • BMI > 25 kg/m2
  • English speaking and reading
  • Ownership of a smartphone with the ability to download applications (i.e., apps)
Show all 9Show fewer
  • Ownership of a smartphone with the ability to receive text messages
  • Willingness to receive a physical activity intervention delivered through their smartphone
  • Willingness to include their first name or create an alias to be used on their profile page on the Smart Walk app

Who cannot join

  • Plans to relocate out of Phoenix area in next 12 months
  • Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a doctor's note for study participation in provided
  • Resting systolic blood pressure greater than 180 mmHG and/or a diastolic blood pressure greater than 120 mmHG , as assessed at baseline or at any other study assessment
  • Self-reported participation in another diet or weight loss study at screening
  • Pregnant or planning to become pregnant in the next 12 months

Trial locations and contacts

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

Rodney P Joseph, PhD contact

602-496-0772

rodney.joseph@asu.edu

United States1 site, 1 recruiting

  • Arizona State University

    Phoenix, Arizona, 85004

    Carina Platte, PhD, (602) 543-2213, carina.platte@asu.edu

    Rodney Joseph, PhD

    Recruiting

Other trials in United States

About this study

Official title: Smart Walk: An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women

The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women.

Read the detailed description

This study addresses major public health concerns among African American women: physical inactivity and cardiometabolic disease risk.

African American women experience a high burden of cardiometabolic diseases, including heart disease, obesity, and type 2 diabetes. Regular aerobic physical activity is an established behavior to prevent and treat these conditions. Yet, the many African American women are insufficiently active, with only 27-40% meeting national aerobic physical activity guidelines.

This study will test the efficacy of Smart Walk, a culturally tailored, theory-based smartphone-delivered intervention designed to increase physical activity and improve cardiometabolic disease risk factors among African American women. In a 12-month trial, participants will be randomly assigned to either the Smart Walk intervention or a Fitbit-only comparison arm for an active 4-month intervention period, followed by an 8-month minimal contact follow-up period.

Specific Aims:

  1. Test the effects of Smart Walk to increase physical activity and promote adherence to national aerobic physical activity guidelines; compared to Fitbit-only comparison group.
  2. Test the effects of Smart Walk to improve cardiometabolic risk factors; compared to Fitbit-only comparison group.
  3. Compare cost and cost effectiveness of the two intervention groups from a societal perspective.
  4. Examine if protocol adherence predicts outcomes and potential mediation and moderation of intervention effects on physical activity and cardiometabolic outcomes.
Being tested
Smart Walk, Fitbit
Keywords
mHealth, women's health, health equity, African American women, Black women, exercise, physical activity, heart disease, diabetes
Medical subject headings
Motor Activity, Heart Diseases, Diabetes Mellitus, Sedentary Behavior

What participants receive

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

  • Smart WalkBehavioural

    Smart Walk is a culturally tailored, Social Cognitive Theory-based multi-component smartphone delivered physical activity (PA) promotion intervention that delivered through the Smart Walk application, virtual physical activity coaching, and text messages. The Smart Walk smartphone application includes four key features: 1) personal profile pages, 2) culturally relevant multi-media physical activity promotion modules, 3) discussion boards, and 4) physical activity self-monitoring/tracking feature that integrates with Fitbit activity monitors for participants to track their daily, weekly, and monthly activity. Virtual physical activity coaches will actively engage and facilitate group-based dialogue among participants on the app discussion boards and provide individualized, one-on-one PA coaching via telephone or commercially available app-based video teleconferencing software (i.e., FaceTime, Zoom, Google hangouts).

  • FitbitBehavioural

    This intervention group will receive a Fitbit activity monitor and be encouraged to use the commercially available device to increase physical activity.

Study groups in NCT06337708
Study groupRoleWhat they receive
Smart WalkExperimentalParticipants will receive a culturally tailored smartphone-delivered physical activity intervention.
Receives: Behavioral: Smart Walk
FitbitActive comparatorParticipants will receive a Fitbit Inspire 3 activity monitor.
Receives: Behavioral: Fitbit

What is being measured

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

  1. Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months

    Participants will wear wrist-worn ActiGraph GT9X Link Activity monitors the activity monitor on their non-dominant wrist during all waking hours for 7 consecutive days to provide an assessment of usual activity

    Measured: Assessed at baseline, 4-months, 12-months

  2. Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months

    Assessed by the 7-Day Physical Activity Recall

    Measured: Assessed at baseline, 4-months, 12-months

Secondary outcomes (19)

  1. Change in cardiorespiratory fitness from baseline to 4- and 12-months

    A modified Balke treadmill protocol will be used to estimate maximal aerobic capacity (i.e., VO2 peak).

    Measured: Assessed at baseline, 4-months, 12-months

  2. Change in aortic pulse wave velocity from baseline to 4- and 12-months

    A measure of aortic stiffness and will be assessed using SphygmoCor XCEL system using validated methodology.

    Measured: Assessed at baseline, 4-months, 12-months

  3. Change in body weight from baseline to 4- and 12-months.

    Measured in kilograms using an electronic scale

    Measured: Assessed at baseline, 4-months, 12-months

  4. Change in body mass index from baseline to 4- and 12-months

    Calculated using the formula: weight (in kilograms) / height (in meters)squared

    Measured: Assessed at baseline, 4-months, 12-months

  5. Change in waste circumference from baseline to 4- and 12-months

    Measured in centimeters

    Measured: Assessed at baseline, 4-months, 12-months

  6. Change in blood pressure (mmHG) from baseline to 4- and 12-months

    Both systolic and diastolic blood pressure will be assessed using electronic sphygmomanometer following 5-min rest

    Measured: Assessed at baseline, 4-months, 12-months

  7. Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months

    Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.

    Measured: Assessed at baseline, 4-months, 12-months

  8. Change in interleukin 6 (IL-6) from baseline to 4- and 12-months

    Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.

    Measured: Assessed at baseline, 4-months, 12-months

  9. Change in interleukin 10 (IL-10) from baseline to 4- and 12-months

    Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.

    Measured: Assessed at baseline, 4-months, 12-months

  10. Change in interleukin 15 (IL-15) from baseline to 4- and 12-months

    Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast.

    Measured: Assessed at baseline, 4-months, 12-months

  11. Change in fasting blood glucose glucose from baseline to 4- and 12-months

    Plasma glucose assessed after a 10 hour fasting blood draw. Measured using an automated chemistry analyzer.

    Measured: Assessed at baseline, 4-months, 12-months

  12. Change in serum insulin from baseline to 4- and 12-months

    Serum insulin collected after a 10 hour fasting blood draw.

    Measured: Assessed at baseline, 4-months, 12-months

  13. Change in serum lipids (mg/DL) from baseline to 4- and 12-months

    Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed

    Measured: Assessed at baseline, 4-months, 12-months

  14. Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months

    Assessed by calculating homeostatic model assessment (HOMA) scores as: glucose (mg/dl) x insulin (μU/ml)/405.

    Measured: Assessed at baseline, 4-months, 12-months

  15. Change in exercise self-efficacy from baseline to 4- and 12-months

    Assessed by the 12-item Exercise Self-Efficacy survey (Sallis et al.1987). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-efficacy.

    Measured: Assessed at baseline, 4-months, 12-months

  16. Change in self-regulation for physical activity from baseline to 4- and 12-months

    Assessed by the 10- item Self-Regulation Scale from the Health Beliefs Survey (Anderson-Bill 2006). This scale assesses the use of behavioral strategies to incorporate physical activity into daily activities (i.e., take stairs instead of elevator, walking instead of driving when running errands). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-regulation.

    Measured: Assessed at baseline, 4-months, 12-months

  17. Change in social support for physical activity from baseline to 4- and 12-months

    Assessed by the Social Support for Exercise survey developed by Sallis et al (1987). This scale assesses social support from family support (10-items, with a possible range of scores from 10-50) and friends (8-items, with a possible score range from from 8-40). Higher scores indicate greater levels of social support.

    Measured: Assessed at baseline, 4-months, 12-months

  18. Change in outcome expectations for physical activity from baseline to 4- and 12-months

    Assessed using the 9-item Outcome Expectation Scale for Exercise scale, developed by Resnick (2000). The range of possible scores for this measure is 1-5, with higher scores indicating more positive expectancies associated with physical activity engagement.

    Measured: Assessed at baseline, 4-months, 12-months

  19. Change in behavioral capability for physical activity from baseline to 4- and 12-months

    Assessed using a 6-item scale developed by the research team in previous research. The range of possible scores for this measure is 1-6, with higher scores indicating higher levels of behavioral capability of physical activity.

    Measured: Assessed at baseline, 4-months, 12-months

Timeline

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

  1. First posted29 Mar 2024
  2. Study start8 Apr 2024
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2029 (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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06337708
Sponsor's protocol ID
STUDY00017286
Other IDs
R01HL168170
Status last verified
Jul 2026
First submitted
29 Jan 2024
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Smart Walk and Fitbit in people with Physical Activity and Exercise, 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 9 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 17 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Rodney P Joseph, PhD (602-496-0772, rodney.joseph@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months (time frame: Assessed at baseline, 4-months, 12-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?

On the ClinicalTrials.gov record for NCT06337708.

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 17 Jul 2026.

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