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Boston Puerto Rican Health Study (BPRHS)

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ClinicalTrials.gov Identifier: NCT01231958
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
Tufts University
Northeastern University
Information provided by (Responsible Party):
Katherine Tucker, University of Massachusetts, Lowell

Brief Summary:
The investigators long-term goal is to understand the complex interactions of diet and other behavioral and environmental factors, genetics, and psychosocial stress on the high and apparently increasing prevalence of cardiovascular disease (CVD) risk factors in Puerto Rican adults.

Condition or disease Intervention/treatment
Cardiovascular Risk Factor Behavioral: The Heart Healthy Initiative for Hispanic Adults (HIP)

Detailed Description:
Puerto Rican adults living on the mainland US have documented health disparities; however, little research has been conducted with this second largest Hispanic subgroup. Our long-term goal is to understand the complex interactions of diet and other behavioral and environmental factors, genetics, and psychosocial stress on the high and apparently increasing prevalence of cardiovascular disease (CVD) risk factors in Puerto Rican adults. As this group is rapidly growing, understanding the reasons for this risk is of great importance. Our initial funding period for the Boston Puerto Rican Center for Population Health and Health Disparities (BPR-CPHHD, 2003-08) focused on the role of stress on physical disability and cognitive decline, through physiological dysregulation or "allostatic load." During that investigation, it became clear that risk factors for CVD were highly prevalent. These findings are in contrast to the commonly held belief that there is a Hispanic paradox--lower heart disease and mortality despite greater poverty. Importantly, the Puerto Rican population differs considerably in ancestral genetic history and in exposures to known risk factors from other Hispanic groups. They have unique dietary intake patterns, as well as social, cultural and environmental structures that contribute and affect reaction to stressors. During our initial funding period, we successfully assembled a cohort of 1500 Puerto Rican adults, aged 45-75 years at baseline, and completed two-year follow-up interviews on more than 1250 participants. As this population is aging and growing rapidly, the high prevalence and apparent cohort effect of increased heart disease risk factors suggest that 1) this population has serious health disparities in heart disease risk factors and 2) heart disease will become an even greater problem for this group in the near future. Our overall aim for this renewal is, therefore, to extend follow-up and to measure and analyze relevant characteristics and CVD risk factors, and to add additional contextual and outcome measures for CVD risk in this established cohort of Puerto Rican adults, so that we may better understand the dynamics of these disparities. Our model follows the transdisciplinary "cells to society" concept developed jointly with our partner CPHHDs during the initial funding period, with consideration of genetic variation in relation to longitudinal change in allostatic load and biochemical indicators of risk; with additional focus on social networks, neighborhood characteristics (physical space and access to food) and environment (air pollution) factors as social determinants of health. Finally, using community based participatory techniques, we will implement and test a multidimensional intervention that focuses on diet and exercise, but that also fully considers the social and physical environment to ensure success. With participation of our community partners, and the support of our administrative, biostatistics and laboratory cores, our team is efficiently poised to make significant contributions to understanding the factors that contribute to the apparent growing threat of heart disease in this highly disadvantaged group—while providing insights that may be useful to other vulnerable groups. The continuation of our cohort, with its rich constellation of measures, will allow us to unravel some of the complex etiologic interactions which contribute to CVD risk, so that effective interventions may be implemented. To date, we have completed approximately 840 5-year follow-up interviews.

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Study Type : Observational
Actual Enrollment : 1650 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Boston Puerto Rican Health Study: Center for Population Health and Health Disparities
Study Start Date : June 2004
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 30, 2017

Intervention Details:
  • Behavioral: The Heart Healthy Initiative for Hispanic Adults (HIP)
    This randomized controlled pilot intervention study will include 150 Hispanic adults (45-75y) in the Greater Boston area. Participants will be randomized to either the intervention or control group after completing their baseline interview. The intervention group will receive 6 months of weekly group educational sessions, Zumba fitness classes and interactions with an embodied computer agent (ECA). The fitness classes and interactions with the ECA will continue for the second 6 months of the 1 year intervention. Intervention activities will occur at community centers in the greater Boston area. Control participants will receive standard of care for the first 6 months and will be offered the full intervention (weekly group educational sessions, Zumba fitness classes and interactions with the ECA) for the second 6 months of the study. Participants will complete an interview and blood draw at baseline, 6 months, and 12 months.


Primary Outcome Measures :
  1. Cardiovascular disease risk [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 10-year risk of Coronary Heart Disease (CHD) [ Time Frame: 5 years ]
    10-year risk of CHD will be assessed using the Framingham Risk Score


Biospecimen Retention:   Samples With DNA
blood, urine, saliva


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Puerto Ricans older adults, aged 45-75 years, living in the Boston area.
Criteria

Inclusion Criteria:

  • self-identified Puerto Rican decent
  • aged 45-75 at baseline
  • able to answer questions in English or Spanish
  • living in the Boston, MA metropolitan area

Exclusion Criteria:

  • unable to answer questions due to serious health conditions
  • plan to move away from the area within two years
  • Mini Mental State Examination (MMSE) score </=10

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231958


Locations
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United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
Northeastern University
Boston, Massachusetts, United States, 02115
University of Massachusetts Lowell
Lowell, Massachusetts, United States, 01854
Sponsors and Collaborators
University of Massachusetts, Lowell
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
Tufts University
Northeastern University
Investigators
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Principal Investigator: Katherine L. Tucker, PhD University of Massachusetts, Lowell

Publications of Results:
Rodrıguez-Galan MB, Falcon LM. Aging Puerto Ricans' Experiences of Depression Treatment: A New Ethnographic Exploration. Research in the Sociology of Health Care 2014;32:275-303.
Adams WE, Todorova IL, Falcon LM. Puerto Rican Crime and Victimization on the Mainland: The Role of Acculturation. Hispanic J Behav Sci 2015;37(1):59-74.
Flores AM, Nelson J, Martinez Tyson D, Stephenson R, Tucker KL. Physical and functional impairments and physical therapy utilization in cancer survivors of Puerto Rican descent. J Oncol Navigation & Survivorship (JONS-online) 2015;6(3):46-55.
Guzzardo MT, Todorova IL, Adams WE, Falcón LM. "Half Here, Half There": Dialogical Selves Among Older Puerto Ricans of the Diaspora. J Constr Psychol 2016;29(1):51-65.
Guzzardo MT, Adams WE, Todorova IL, Falcón LM. Resonating sentiments on Puerto Rican identity through poetry: Voices of the diaspora. Qualitative Inquiry 2016 doi: 10.1177/1077800415622485

Other Publications:
Glik D, Sharif MZ, Tucker KL, Tejada SA, Prelip ML, Ammerman AS, Keyserling TC, Torres SE, Pitts SJ. Community engagement to support cardiovascular disease prevention in disparities populations: three case studies. J Health Dispar Res Pract Apr 2016;9:71-87.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Katherine Tucker, Professor, University of Massachusetts, Lowell
ClinicalTrials.gov Identifier: NCT01231958     History of Changes
Other Study ID Numbers: P50HL105185 ( U.S. NIH Grant/Contract )
P01AG023394 ( U.S. NIH Grant/Contract )
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Keywords provided by Katherine Tucker, University of Massachusetts, Lowell:
Puerto Rican; CVD; Hispanic; health disparities; allostatic load; diet