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

NCT ID: NCT06337708

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Physical Activity Exercise Heart Diseases Diabetes Mellitus Physical Inactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Smart Walk

Participants will receive a culturally tailored smartphone-delivered physical activity intervention.

Group Type EXPERIMENTAL

Smart Walk

Intervention Type BEHAVIORAL

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).

Fitbit

Participants will receive a Fitbit Inspire 3 activity monitor.

Group Type ACTIVE_COMPARATOR

Fitbit

Intervention Type BEHAVIORAL

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

Interventions

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Smart Walk

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).

Intervention Type BEHAVIORAL

Fitbit

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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 \> 30 kg/m2
* English speaking and reading
* Ownership of a smartphone with the ability to download applications (i.e., apps)
* 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

Exclusion Criteria

* 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
Minimum Eligible Age

24 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona State University

Phoenix, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rodney P Joseph, PhD

Role: CONTACT

602-496-0772

Facility Contacts

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Carina Platte, PhD

Role: primary

602-543-2213

Other Identifiers

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R01HL168170

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00017286

Identifier Type: -

Identifier Source: org_study_id

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