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Raices: A Promotores Network to Improve Latino Immigrant Health

11 de febrero de 2019 actualizado por: Sharon Ross, University of Pittsburgh

Raices: A Promotores Network to Improve the Health Behaviors and Health Outcomes of Latino Immigrants Living in an Emerging Latino Community

This study examines the effectiveness of a community health worker (promotores) network in improving access to care, social support, physical activity and nutrition in Latino immigrants living in an emerging Latino community.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

This proposal examines the potential of a community health worker (CHW) network to improve health behaviors and health outcomes of Latino immigrants living in an Emerging Latino Community (ELC; areas with low (<5%), yet growing concentrations of Latinos).CHWs (promotores in Spanish) are trained individuals from the community who establish interpersonal connections to reach and serve Latinos and address health disparities.

This proposal builds on two pilot studies conducted by the investigative team: (1) a community-based intervention delivered by promotores to increase social support and health care access in immigrant men, and (2) a home-based intervention delivered by promotoras to improve nutrition and physical activity in Latino preschool children and their families.

Little is known about the potential usefulness of a promotores network in improving both health care access and engagement in physical activity and healthy eating, compared with standard informational approaches, among Latino immigrants from an ELC. The proposed research will address the following specific aims:

(Sp. Aim 1) Develop and implement a structured, promotor/a-mediated intervention to increase access to care, social support, and engagement in health-promoting behaviors; (Sp. Aim 2) Examine the feasibility of a structured, promotor/a-mediated approach to peer support, with a participant-guided goal-setting component; and (Sp. Aim 3) Assess the effectiveness of a promotores network on increasing access to care, social support, and engagement in health-promoting behaviors compared with a waitlist-control group. Partnering with a federally-qualified health center and a social service organization, the investigators propose to employ a quasi-experimental design to assess the effect of a promotores network on outcomes measured at 6 months after enrollment, compared with a wait-list control.

The research team will hire and train 16 promotores and 8 community liaisons to recruit, assess, and deliver the intervention (promotores only). Participants will include adults and children (≥ 11 years) drawn from Allegheny County, Pennsylvania (an ELC). Promotores and RIs will recruit n=200 intervention and n=200 control participants using similar protocols from our pilot studies (e.g., word-of-mouth, flyers). The 6 month intervention will include using motivational interviewing techniques and intervention tools adapted from our previous work, to assist promotores in eliciting the participants' most important needs drawn from 8 life domains (e.g., health care, exercise/recreation, social life).

Promotores will guide the participant to set goals and follow-up over the 6 month intervention period (in-person and via phone) to measure progress, address barriers, and deliver short educational (health promotion) sessions.

Process evaluation includes a comprehensive set of questions to assess fidelity, dose, reach, recruitment and contextual factors using multiple data sources. Primary outcomes include access to care (preventive and usual source of care), social support, physical activity, and dietary intake. Expected outcomes include: (1) gain valuable information surrounding feasibility and effectiveness of proposed intervention protocol, (2) contribute to improving access to care and increasing health-promoting behaviors in Latinos living in an ELC, and (3) contribute to reducing health disparities in Latino individuals and families. The objectives of this project are in line with both the CMS mission of promoting better care, healthier people, and smarter spending for beneficiaries, and the Healthy People 2020 goals of eliminating disparities. This proposal carries high public health significance because it targets Latino health disparities through primary prevention and a structured approach to peer support, as well as maximizes the potential of both men and women promotores to assist participants living in an ELC

Tipo de estudio

Intervencionista

Inscripción (Actual)

398

Fase

  • No aplica

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.

Ubicaciones de estudio

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15260
        • University of Pittsburgh

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

11 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. are between 2 -18 years of age (children) or ≥ 18 years of age (adult),
  2. self-identify as Hispanic/Latino,
  3. speak English/Spanish, and
  4. live in Allegheny County, Pennsylvania.

Exclusion Criteria:

  1. non-Hispanic/Latino,
  2. primary language other than Spanish or English, or
  3. cognitive limitation to complete surveys or interviews.

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

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Promotores Network
Promotores will engage participants using the materials A Page of My Life and the Success Plan. Promotores will ask participants to rank their satisfaction with each of the domains included in the A Page of My Life and ask them what domain they want to change. Using non-directive questions, promotores will guide the participant to draft a plan for success. The promotor/a will follow up with participants within a week of enrollment and at least monthly via phone/text during six months. During the intervention period, promotores will meet with participants (child and parent together, if applicable) at least three times in-person during which they will deliver the short (15-minutes) educational components of the intervention.
One-on-one contact with a promotor(a) over the 6 month intervention.
Sin intervención: Wait-list Control
The community liaison will deliver a short (15-minute) educational session on the benefits of a healthy lifestyle and preventive use of health care, and give participants a pamphlet with relevant local health care and social service resources.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in number of participants who have access to care
Periodo de tiempo: 6 months
# of participants having any health insurance, usual source of care, visit to Dr. or visit to dentist.
6 months
Change in Social Support
Periodo de tiempo: 6 months
12-item scale
6 months
Change in Physical Activity levels
Periodo de tiempo: 6 months
Min/day of self-reported moderate-to-vigorous physical activity:
6 months
Change in Dietary Behaviors
Periodo de tiempo: 6 months
Usual Dietary intake
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in BMI
Periodo de tiempo: 6 months
calculated using standard equation (kg/m^2)
6 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Sharon E Ross, PhD, University of Pittsburgh

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)

30 de mayo de 2017

Finalización primaria (Actual)

31 de enero de 2019

Finalización del estudio (Actual)

31 de enero de 2019

Fechas de registro del estudio

Enviado por primera vez

7 de abril de 2017

Primero enviado que cumplió con los criterios de control de calidad

21 de abril de 2017

Publicado por primera vez (Actual)

26 de abril de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de febrero de 2019

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

11 de febrero de 2019

Última verificación

1 de febrero de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PRO17020357

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. .

Ensayos clínicos sobre Comportamiento de salud

Ensayos clínicos sobre Intervention group

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