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Universidad Estatal de ArizonaSmart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
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El ensayo clínico NCT06337708 está diseñado para estudiar la prevención de Actividad física, Ejercicio, Enfermedades cardíacas, Diabetes mellitus, Inactividad física. Es un estudio intervencionista de Fase II. Su estado actual es: reclutando. El ensayo se inició el 8 de abril de 2024, con el objetivo de reclutar a 240 participantes. Dirigido por la Universidad Estatal de Arizona, se espera que finalice el 31 de marzo de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 16 de mayo de 2025.
Resumen
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.
Descripción detallada
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:
- 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.
- Test the effects of Smart Walk to improve cardiometabolic risk factors; compared to Fitbit-only comparison group.
- Compare cost and cost effectiveness of the two intervention groups from a societal perspective.
- Examine if protocol adherence predicts outcomes and potential mediation and moderation of intervention effects on physical activity and cardiometabolic outcomes.
Título oficial
Smart Walk: An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
Condiciones médicas
Actividad físicaEjercicioEnfermedades cardíacasDiabetes mellitusInactividad físicaOtros ID del ensayo
- STUDY00017286
- R01HL168170 (Subvención/contrato NIH (EE. UU.))
Número del NCT
Inicio del ensayo (real)
2024-04-08
Última actualización
2025-05-16
Fecha de finalización (estimada)
2028-03-31
Inscripción (prevista)
240
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Reclutando
Palabras clave
mHealth
women's health
health equity
African American women
Black women
exercise
physical activity
heart disease
diabetes
women's health
health equity
African American women
Black women
exercise
physical activity
heart disease
diabetes
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalSmart Walk Participants will receive a culturally tailored smartphone-delivered physical activity intervention. | 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). |
Comparador activoFitbit Participants will receive a Fitbit Inspire 3 activity monitor. | FitBit This intervention group will receive a Fitbit activity monitor and be encouraged to use the commercially available device to increase physical activity. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
24 Years
Criterios de sexo
Mujer
Admisión de voluntarios sanos
Sí
- 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
- 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
Universidad Estatal de Arizona83 ensayos clínicos activos para explorarInstituto Nacional de Alergias y Enfermedades Infecciosas, Estados Unidos758 ensayos clínicos activos para explorarContactos centrales del ensayo
Contacto: Rodney P Joseph, PhD, 602-496-0772, [email protected]
1 Sitios del ensayo en 1 países
Arizona
Arizona State University, Phoenix, Arizona, 85004, United States
Carina Platte, PhD, Contacto, 602-543-2213, [email protected]
Rodney Joseph, PhD, Investigador principal
Reclutando