This trial is active, not recruiting.

Condition cardiovascular risk factor
Treatment the heart healthy initiative for hispanic adults (hip)
Sponsor University of Massachusetts, Lowell
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date June 2004
End date October 2009
Trial size 1650 participants
Trial identifier NCT01231958, P01AG023394, P50HL105185


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Cardiovascular disease risk
time frame: 5 years

Secondary Outcomes

10-year risk of Coronary Heart Disease (CHD)
time frame: 5 years

Eligibility Criteria

Male or female participants from 45 years up to 75 years old.

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

Additional Information

Official title The Boston Puerto Rican Health Study: Center for Population Health and Health Disparities
Principal investigator Katherine L. Tucker, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Massachusetts, Lowell.