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

NCT06337708 | Recruiting Phase 2 DMC

• 2 other identifiers: STUDY00017286R01HL168170
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  Assessed at baseline, 4-months, 12-months

• 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

  Assessed at baseline, 4-months, 12-months

Secondary Outcomes (19)

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

  Assessed at baseline, 4-months, 12-months

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

  Assessed at baseline, 4-months, 12-months

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

  Assessed at baseline, 4-months, 12-months

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

  Assessed at baseline, 4-months, 12-months

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

  Assessed at baseline, 4-months, 12-months

Other Outcomes (9)

• Treatment acceptance

  Assessed at 4-months and 12-months

• Protocol Adherence

  Assessed at 4-months and 12-months

• Program costs

  Assessed at 4-months and 12-months

Study Arms (2)

Smart Walk

EXPERIMENTAL

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

Behavioral: Smart Walk

Fitbit

ACTIVE COMPARATOR

Participants will receive a Fitbit Inspire 3 activity monitor.

Behavioral: Fitbit

Interventions

Smart Walk 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).

Smart Walk

Fitbit BEHAVIORAL

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

Fitbit

Eligibility Criteria

• Age: 24 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity; Heart Diseases; Diabetes Mellitus; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Rodney P Joseph, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: March 29, 2024
• Study Start: April 8, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (1)