protocolSection identificationModule nctId: NCT06337708, orgStudyIdInfo id: STUDY00017286, secondaryIdInfos id: R01HL168170, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL168170, briefTitle: Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Arizona State University, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: 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., conditionsModule conditions: Physical Activity, conditions: Exercise, conditions: Heart Diseases, conditions: Diabetes Mellitus, conditions: Physical Inactivity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Smart Walk, interventions name: Fitbit, outcomesModule primaryOutcomes measure: Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months, primaryOutcomes measure: Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months, secondaryOutcomes measure: Change in cardiorespiratory fitness from baseline to 4- and 12-months, secondaryOutcomes measure: Change in aortic pulse wave velocity from baseline to 4- and 12-months, secondaryOutcomes measure: Change in body weight from baseline to 4- and 12-months., secondaryOutcomes measure: Change in body mass index from baseline to 4- and 12-months, secondaryOutcomes measure: Change in waste circumference from baseline to 4- and 12-months, secondaryOutcomes measure: Change in blood pressure (mmHG) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in interleukin 6 (IL-6) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in interleukin 10 (IL-10) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in interleukin 15 (IL-15) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in fasting blood glucose glucose from baseline to 4- and 12-months, secondaryOutcomes measure: Change in serum insulin from baseline to 4- and 12-months, secondaryOutcomes measure: Change in serum lipids (mg/DL) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in exercise self-efficacy from baseline to 4- and 12-months, secondaryOutcomes measure: Change in self-regulation for physical activity from baseline to 4- and 12-months, secondaryOutcomes measure: Change in social support for physical activity from baseline to 4- and 12-months, secondaryOutcomes measure: Change in outcome expectations for physical activity from baseline to 4- and 12-months, secondaryOutcomes measure: Change in behavioral capability for physical activity from baseline to 4- and 12-months, otherOutcomes measure: Treatment acceptance, otherOutcomes measure: Protocol Adherence, otherOutcomes measure: Program costs, otherOutcomes measure: Participant costs, otherOutcomes measure: Cost-effectiveness, otherOutcomes measure: Objectively-measured home neighborhood characteristics, otherOutcomes measure: Subjectively-measured Neighborhood environment walkability, otherOutcomes measure: Race-related Stress, otherOutcomes measure: Perceived Structural Racism, eligibilityModule sex: FEMALE, minimumAge: 24 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arizona State University, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85004, country: United States, contacts name: Carina Platte, PhD, role: CONTACT, phone: 602-543-2213, email: carina.platte@asu.edu, contacts name: Rodney Joseph, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, hasResults: False