Raices: A Promotores Network to Improve Latino Immigrant Health

NCT ID: NCT03129633

Last Updated: 2019-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-30

Study Completion Date

2019-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Health Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Intervention group

Intervention Type OTHER

One-on-one contact with a promotor(a) over the 6 month 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention group

One-on-one contact with a promotor(a) over the 6 month intervention.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sharon Ross

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sharon E Ross, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRO17020357

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Heart of the Community Study
NCT05560893 COMPLETED NA
CommunityRx-Cardiovascular Disease
NCT06264726 ACTIVE_NOT_RECRUITING NA
SER Hispano Longitudinal Study
NCT03527654 COMPLETED