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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Diabetes Mellitus; Physical Activity; Exercise; Physical Inactivity
• Intervention / Treatment: Behavioral: Smart Walk; Behavioral: Fitbit

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rodney P Joseph, PhD; Phone Number: 602-496-0772; Email: rodney.joseph@asu.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • Arizona State University
      • Contact: Carina Platte, PhD; Phone Number: 602-543-2213; Email: carina.platte@asu.edu
      • Principal Investigator: Rodney Joseph, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart Walk; Participants will receive a culturally tailored smartphone-delivered physical activity intervention.	Behavioral: 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).
Active Comparator: Fitbit; Participants will receive a Fitbit Inspire 3 activity monitor.	Behavioral: Fitbit; This intervention group will receive a Fitbit activity monitor and be encouraged to use the commercially available device to increase physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months
Change in body weight from baseline to 4- and 12-months.	Measured in kilograms using an electronic scale	Assessed at baseline, 4-months, 12-months
Change in body mass index from baseline to 4- and 12-months	Calculated using the formula: weight (in kilograms) / height (in meters)squared	Assessed at baseline, 4-months, 12-months
Change in waste circumference from baseline to 4- and 12-months	Measured in centimeters	Assessed at baseline, 4-months, 12-months
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	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months
Change in serum insulin from baseline to 4- and 12-months	Serum insulin collected after a 10 hour fasting blood draw.	Assessed at baseline, 4-months, 12-months
Change in serum lipids (mg/DL) from baseline to 4- and 12-months	Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months
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.	Assessed at baseline, 4-months, 12-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment acceptance	Survey assessing acceptance, feasibility, and consumer satisfaction of intervention.	Assessed at 4-months and 12-months
Protocol Adherence	Fitbit wear, app utilization, and adherence to physical activity coaching session protocols will be assessed as moderators.	Assessed at 4-months and 12-months
Program costs	Costs borne by the program, including Fitbit activity monitors, Smart Walk app development, and all personnel salaries/hourly wages.	Assessed at 4-months and 12-months
Participant costs	Participant costs associated with study participation, including time spent using the Smart Walk app, time spent in physical activity coaching, and cellular phone data charges over their plan limit.	Assessed at 4-months and 12-months
Cost-effectiveness	Cost effectiveness will be evaluated by combining the mean total cost per participant with effectiveness (baseline to 12-month changes in minutes/week of moderate-to-vigorous physical activity). We will calculate the incremental cost effectiveness ratios (ICER) for the Smart Walk intervention compared to the Fitbit comparison arm.	Assessed at 4-months and 12-month
Objectively-measured home neighborhood characteristics	GIS mapping and computer vision techniques will be used to assess macro-scale and micro-scale home neighborhood environment characteristics of participants.	Assessed at baseline
Subjectively-measured Neighborhood environment walkability	Subjectively-measured Neighborhood Environment Walkability will be measured using the Neighborhood Environment Walkability Scale (NEWS). This measure includes 43 items and assesses the following environmental characteristics: residential density (6-items, possible range of scores range 1-5), land use mix-diversity (22 items, possible range of scores range 1-5), street connectivity (2 items, possible range of scores range 1-4), walking/cycling facilities (6 items, possible range of scores range 1-4), aesthetics (4 items, possible range of scores 1-4), pedestrian/traffic safety (3 items, possible range of scores 1-4). Higher scores indicate greater walkability.	Assessed at baseline
Race-related Stress	Race-related stress, as a result of experiencing individual, cultural and institutional racism, will be assessed using the 22-item Index of Race-Related Stress-Brief survey. This survey has a possible score range of 0 to 88, with higher scored indicating greater stress as a result of experiencing racism.	Assessed at baseline
Perceived Structural Racism	Structural racism will be assessed using the 20-item Perceived Structural Racism Scale. This scale has a possible scoring range of 20-120 with higher scores indicating greater levels of perceived structural racism.	Assessed at baseline

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: diabetes; physical activity; exercise; mHealth; women's health; heart disease; Black women; health equity; African American women
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: STUDY00017286; R01HL168170 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No