Recruiting
Phase 2

Physical Activity

Sponsor:

Arizona State University

Code:

NCT06337708

Conditions

Physical Activity

Exercise

Heart Diseases

Diabetes Mellitus

Physical Inactivity

Eligibility Criteria

Sex: Female

Age: 24 - 65

Healthy Volunteers: Accepted

Interventions

Smart Walk

Fitbit

Study Details

Brief 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.

Conditions

Physical Activity

Exercise

Heart Diseases

Diabetes Mellitus

Physical Inactivity

Study ID

NCT06337708

Start date

Apr 8, 2024

Status verified date

Jul, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 24 - 65

Healthy Volunteers: Accepted

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 > 25 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

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Smart Walk

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

active comparator: Fitbit

Participants will receive a Fitbit Inspire 3 activity monitor.

Interventions

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).

Fitbit

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

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 ]
  • Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months [ Time Frame: Assessed at baseline, 4-months, 12-months ]

Central Contacts and Locations

Central contacts

Rodney P Joseph, PhD

602-496-0772rodney.joseph@asu.edu

Locations

Arizona State University

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Carina Platte, PhD

(602) 543-2213carina.platte@asu.edu

Principal Investigator:

Rodney Joseph, PhD

More Information

Sponsor

Arizona State University

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • mHealth
  • women's health
  • health equity
  • African American women
  • Black women
  • exercise
  • physical activity
  • heart disease
  • diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arizona State University on 2026-07-17.