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Digital Intervention Participation in DASH

23 de abril de 2021 actualizado por: Loneke T. Blackman Carr, PhD, RD, University of Connecticut

Optimizing Inclusion of Blacks Within a Dietary Change Intervention to Reduce Hypertension

This study will examine the context of making high quality dietary choices among Black adults with hypertension. Secondly, this study will also investigate what Black adults need or desire to participate in a digital intervention to improve dietary quality by adopting the DASH eating pattern.

Descripción general del estudio

Descripción detallada

Nearly 50% of adults in the United States have high blood pressure, a leading contributor to cardiovascular disease. When race is considered, the majority of black adults (55%) have high blood pressure, a greater prevalence than other racial/ethnic groups. The elevated rate of high blood pressure, a diet-related disease, reflects the sub-optimal diet quality observed in blacks. The DASH dietary pattern is an evidence-based strategy to treat high blood pressure that has become part of the Dietary Guidelines for Americans. DASH promotes a diet rich in fruits and vegetables, low-fat dairy, controlled amounts of total fat, cholesterol and saturated fat, high fiber and protein content. Data from the National Health and Nutrition Examination Survey indicate that approximately 19% of adults with high blood pressure were DASH adherent. Those who were adherent tended to be older and non-black with a higher education level. Even after intervention, lower DASH adherence scores have been seen in blacks versus whites, possibly due to lower baseline consumption of DASH foods in blacks. Although dietary improvements from DASH-promoting interventions have been observed, adherence has decreased over time, and when translated to less controlled settings. Sufficient representation of blacks is important for clinical trials testing DASH given the disproportionate prevalence of high blood pressure. This study will examine factors that may influence black adults' participation and success in improving dietary quality through the following aims:

  1. To identify barriers to and facilitators of recruiting black adults into a digital DASH-promoting intervention. A semi-structured interview guide will direct individual interviews via phone with black men and women to understand what supports or deters participation in a digital health intervention trial for dietary quality improvement.
  2. To determine the barriers and facilitators to improving dietary quality in black adults.

    Participants in the individual interviews (Aim 1) will also identify their motivations, concerns and priorities surrounding dietary change. This will inform recruitment efforts and our understanding about how to improve dietary quality.

  3. To conduct secondary data analyses to determine the effectiveness, by race and gender group, of various recruitment methods from a 12-month randomized controlled trial to examine the effects of the intervention on changes in dietary quality and blood pressure among men and women with high blood pressure (clinical trails identifier: NCT03875768). The intervention asks participants to track their diet daily using a common commercial tracking app with an extensive nutrient database via smartphone. Food and nutrient data from the app is processed using an application programming interface, compared against an algorithm, and generates personalized automated text messages to each participant with information on DASH diet adherence and diet tips. Responsive coaching is also included for participants that require greater support for dietary change.

Diverse sample recruitment is essential to producing outcomes that are applicable to diverse populations living with hypertension. Examination of barriers and facilitators to consuming a quality diet and identification of effective recruitment methods for digital interventions may inform how investigators reach black men and women with hypertension to effectively improve diet for the treatment of cardiovascular disease.

Tipo de estudio

De observación

Inscripción (Anticipado)

30

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Connecticut
      • Storrs, Connecticut, Estados Unidos, 06103
        • Reclutamiento
        • University of Connecticut
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Community sample

Descripción

Inclusion Criteria:

  • self-identify as having high blood pressure
  • self-identify as Black/African American/Afro-Caribbean
  • at least 18 years old
  • self-reported body mass index≥ 18.5 kg/m2
  • email address
  • English is primary language

Exclusion Criteria:

  • planning to leave the area during study time period
  • participating in a related trial
  • cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
  • pregnancy - current or planned during the study period
  • active malignancy
  • recent psychiatric institutionalization
  • documented dementia

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Barriers and facilitators of recruitment
Periodo de tiempo: day 1
Using individual interviews to elicit information of potential recruitment preferences
day 1

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Barriers and facilitators of diet quality
Periodo de tiempo: day 1
Individual interviews to understand black men/women's diet quality experiences
day 1
Comparison of recruitment methods
Periodo de tiempo: Baseline
Use recruitment data collected from the main trial to compare the most effective recruitment methods for black men and women
Baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Loneke Blackman Carr, PhD, RD, University of Connecticut

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de septiembre de 2020

Finalización primaria (Anticipado)

31 de marzo de 2023

Finalización del estudio (Anticipado)

31 de marzo de 2023

Fechas de registro del estudio

Enviado por primera vez

12 de agosto de 2020

Primero enviado que cumplió con los criterios de control de calidad

12 de agosto de 2020

Publicado por primera vez (Actual)

17 de agosto de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de abril de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

23 de abril de 2021

Última verificación

1 de abril de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • KFS 5658780
  • 3R01HL146768-01S1 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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