- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03129633
Raices: A Promotores Network to Improve Latino Immigrant Health
Raices: A Promotores Network to Improve the Health Behaviors and Health Outcomes of Latino Immigrants Living in an Emerging Latino Community
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15260
- University of Pittsburgh
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- non-Hispanic/Latino,
- primary language other than Spanish or English, or
- cognitive limitation to complete surveys or interviews.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
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One-on-one contact with a promotor(a) over the 6 month intervention.
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Nessun intervento: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in number of participants who have access to care
Lasso di tempo: 6 months
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# of participants having any health insurance, usual source of care, visit to Dr. or visit to dentist.
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6 months
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Change in Social Support
Lasso di tempo: 6 months
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12-item scale
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6 months
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Change in Physical Activity levels
Lasso di tempo: 6 months
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Min/day of self-reported moderate-to-vigorous physical activity:
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6 months
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Change in Dietary Behaviors
Lasso di tempo: 6 months
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Usual Dietary intake
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6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in BMI
Lasso di tempo: 6 months
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calculated using standard equation (kg/m^2)
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6 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Sharon E Ross, PhD, University of Pittsburgh
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- PRO17020357
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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