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Completed

NCT Number: NCT01231958

Boston Puerto Rican Health Study

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northeastern University, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Heart Healthy Initiative for Hispanic Adults (HIP)

Behavioral

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 outcomes

  1. Cardiovascular disease risk

    Time frame: 5 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Lowell

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute on Aging (NIA)
  • Northeastern University
  • Tufts University

Registry information

Official study title

The Boston Puerto Rican Health Study: Center for Population Health and Health Disparities

Acronym: BPRHS

Important dates

Study start
2004
Primary completion
2009
Study completion
2017
First posted
Nov 1, 2010
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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