Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03129633
Other study ID # PRO17020357
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2017
Est. completion date January 31, 2019

Study information

Verified date February 2019
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 398
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in number of participants who have access to care # of participants having any health insurance, usual source of care, visit to Dr. or visit to dentist. 6 months
Primary Change in Social Support 12-item scale 6 months
Primary Change in Physical Activity levels Min/day of self-reported moderate-to-vigorous physical activity: 6 months
Primary Change in Dietary Behaviors Usual Dietary intake 6 months
Secondary Change in BMI calculated using standard equation (kg/m^2) 6 months
See also
  Status Clinical Trial Phase
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Recruiting NCT04356924 - Psychological Treatment to Support the Consequences of Cognitive Impairment N/A
Completed NCT05509049 - Precision Nudging Drives Wellness Visit Attendance at Scale N/A
Completed NCT03904992 - Intervention With a Progressive Web App for the Promotion of Healthy Habits in Preschoolers N/A
Completed NCT05509270 - Efficacy of Communication Modalities for Promoting Flu Shots N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03081520 - Affective Responses Following Aerobic Exercise With Different Intensities N/A
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT03982095 - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Recruiting NCT06467058 - Convergent Validity of DABQ Questionnaire N/A
Completed NCT02777086 - Sustainable HIV Risk Reduction Strategies for Probationers N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Not yet recruiting NCT06071130 - Emotion, Aging, and Decision Making N/A
Active, not recruiting NCT04152824 - Readiness Supportive Leadership Training N/A
Active, not recruiting NCT05541653 - The IGNITE Study on Concentrated Investment in Black Neighborhoods N/A
Completed NCT03875768 - Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure N/A
Completed NCT04089020 - Walking to School Supports N/A
Completed NCT03646903 - Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk N/A
Completed NCT03548077 - POWERPLAY: Promoting Men's Health at Work N/A
Recruiting NCT05249465 - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention N/A