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Raices: A Promotores Network to Improve Latino Immigrant Health

This study is not yet open for participant recruitment.
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Verified April 2017 by Sharon Ross, University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Sharon Ross, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03129633
First received: April 7, 2017
Last updated: April 21, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Health Behavior Other: Intervention group

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Raices: A Promotores Network to Improve the Health Behaviors and Health Outcomes of Latino Immigrants Living in an Emerging Latino Community

Further study details as provided by Sharon Ross, University of Pittsburgh:

Primary Outcome Measures:
  • Change in number of participants who have access to care [ Time Frame: 6 months ]
    # of participants having any health insurance, usual source of care, visit to Dr. or visit to dentist.

  • Change in Social Support [ Time Frame: 6 months ]
    abbreviated scale, 4 items

  • Change in Physical Activity levels [ Time Frame: 6 months ]
    Min/day of moderate-to-vigorous physical activity:

  • Change in Dietary Behaviors [ Time Frame: 6 months ]
    Usual Dietary intake


Secondary Outcome Measures:
  • Change in BMI [ Time Frame: 6 months ]
    calculated using standard equation (kg/m^2)


Estimated Enrollment: 400
Anticipated Study Start Date: May 30, 2017
Estimated Study Completion Date: September 29, 2018
Estimated Primary Completion Date: September 29, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Intervention group
One-on-one contact with a promotor(a) over the 6 month intervention.
No Intervention: 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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   11 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. are between 11 -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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03129633

Contacts
Contact: Sharon Ross E Primary Investigator 412-383-4042 seross@pitt.edu

Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sharon E Ross, PhD University of Pittsburgh
  More Information

Responsible Party: Sharon Ross, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03129633     History of Changes
Other Study ID Numbers: PRO17020357
Study First Received: April 7, 2017
Last Updated: April 21, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on July 26, 2017