- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, 미국, 15260
- University of Pittsburgh
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
|
One-on-one contact with a promotor(a) over the 6 month intervention.
|
간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in number of participants who have access to care
기간: 6 months
|
# of participants having any health insurance, usual source of care, visit to Dr. or visit to dentist.
|
6 months
|
Change in Social Support
기간: 6 months
|
12-item scale
|
6 months
|
Change in Physical Activity levels
기간: 6 months
|
Min/day of self-reported moderate-to-vigorous physical activity:
|
6 months
|
Change in Dietary Behaviors
기간: 6 months
|
Usual Dietary intake
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in BMI
기간: 6 months
|
calculated using standard equation (kg/m^2)
|
6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sharon E Ross, PhD, University of Pittsburgh
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PRO17020357
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
건강 행동에 대한 임상 시험
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH) 그리고 다른 협력자들모집하지 않고 적극적으로
-
University of Dublin, Trinity College알려지지 않은Brain Health 은퇴 엘리트 선수
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University아직 모집하지 않음Focus Health 임산부
-
University College London HospitalsUniversity College, London완전한
-
Istanbul University - Cerrahpasa (IUC)모병
Intervention group에 대한 임상 시험
-
Bezmialem Vakif UniversityProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization; Istanbul Sultanbeyli... 그리고 다른 협력자들완전한
-
Aarhus University HospitalUniversity of Aarhus완전한
-
VA Office of Research and Development모집하지 않고 적극적으로
-
Washington University School of MedicineSt. Jude Children's Research Hospital완전한
-
Maharishi Markendeswar University (Deemed to be...완전한