Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-06 @ 8:00 AM
Study NCT ID:
NCT03129633
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2017-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Raices: A Promotores Network to Improve Latino Immigrant Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-11', 'studyFirstSubmitDate': '2017-04-07', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of participants who have access to care', 'timeFrame': '6 months', 'description': '\\# of participants having any health insurance, usual source of care, visit to Dr. or visit to dentist.'}, {'measure': 'Change in Social Support', 'timeFrame': '6 months', 'description': '12-item scale'}, {'measure': 'Change in Physical Activity levels', 'timeFrame': '6 months', 'description': 'Min/day of self-reported moderate-to-vigorous physical activity:'}, {'measure': 'Change in Dietary Behaviors', 'timeFrame': '6 months', 'description': 'Usual Dietary intake'}], 'secondaryOutcomes': [{'measure': 'Change in BMI', 'timeFrame': '6 months', 'description': 'calculated using standard equation (kg/m\\^2)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Behavior']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThis 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.\n\nLittle 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:\n\n(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.\n\nThe 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).\n\nPromotores 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.\n\nProcess 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. are between 2 -18 years of age (children) or ≥ 18 years of age (adult),\n2. self-identify as Hispanic/Latino,\n3. speak English/Spanish, and\n4. live in Allegheny County, Pennsylvania.\n\nExclusion Criteria:\n\n1. non-Hispanic/Latino,\n2. primary language other than Spanish or English, or\n3. cognitive limitation to complete surveys or interviews.'}, 'identificationModule': {'nctId': 'NCT03129633', 'briefTitle': 'Raices: A Promotores Network to Improve Latino Immigrant Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Raices: A Promotores Network to Improve the Health Behaviors and Health Outcomes of Latino Immigrants Living in an Emerging Latino Community', 'orgStudyIdInfo': {'id': 'PRO17020357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Promotores Network', 'description': '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.', 'interventionNames': ['Other: Intervention group']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list Control', 'description': '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': [{'name': 'Intervention group', 'type': 'OTHER', 'description': 'One-on-one contact with a promotor(a) over the 6 month intervention.', 'armGroupLabels': ['Promotores Network']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Sharon E Ross, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sharon Ross', 'investigatorAffiliation': 'University of Pittsburgh'}}}}