NCT03129633

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
398

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

April 7, 2017

Last Update Submit

February 11, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • Change in Social Support

    12-item scale

    6 months

  • Change in Physical Activity levels

    Min/day of self-reported moderate-to-vigorous physical activity:

    6 months

  • Change in Dietary Behaviors

    Usual Dietary intake

    6 months

Secondary Outcomes (1)

  • Change in BMI

    6 months

Study Arms (2)

Promotores Network

EXPERIMENTAL

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

Wait-list Control

NO INTERVENTION

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.

Interventions

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

Promotores Network

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sharon E Ross, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 26, 2017

Study Start

May 30, 2017

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations