Clinical trial NCT01231958: Boston Puerto Rican Health Study
Official title: The Boston Puerto Rican Health Study: Center for Population Health and Health Disparities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Risk Factor
Keywords: Puerto Rican; CVD; Hispanic; health disparities; allostatic load; diet
Lead sponsor: University of Massachusetts, Lowell
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute on Aging (NIA)
name: Tufts University
name: Northeastern University
First posted: 2010-11-01
Enrollment: 1650
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Puerto Ricans older adults, aged 45-75 years, living in the Boston area.

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.

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.

Eligibility 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

Primary outcomes:
measure: Cardiovascular disease risk
timeFrame: 5 years
Secondary outcomes:
measure: 10-year risk of Coronary Heart Disease (CHD)
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
city: Lowell
country: United States
facility: University of Massachusetts Lowell
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Lowell
name: Katherine L. Tucker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lai CQ, Tucker KL, Parnell LD, Adiconis X, Garcia-Bailo B, Griffith J, Meydani M, Ordovas JM. PPARGC1A variation associated with DNA damage, diabetes, and cardiovascular diseases: the Boston Puerto Rican Health Study. Diabetes. 2008 Apr;57(4):809-16. doi: 10.2337/db07-1238. Epub 2007 Dec 27.
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citation: DeVos L, Chanson A, Liu Z, Ciappio ED, Parnell LD, Mason JB, Tucker KL, Crott JW. Associations between single nucleotide polymorphisms in folate uptake and metabolizing genes with blood folate, homocysteine, and DNA uracil concentrations. Am J Clin Nutr. 2008 Oct;88(4):1149-58. doi: 10.1093/ajcn/88.4.1149.
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citation: Shen J, Lai CQ, Mattei J, Ordovas JM, Tucker KL. Association of vitamin B-6 status with inflammation, oxidative stress, and chronic inflammatory conditions: the Boston Puerto Rican Health Study. Am J Clin Nutr. 2010 Feb;91(2):337-42. doi: 10.3945/ajcn.2009.28571. Epub 2009 Dec 2.
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citation: Rioux CL, Tucker KL, Mwamburi M, Gute DM, Cohen SA, Brugge D. Residential traffic exposure, pulse pressure, and C-reactive protein: consistency and contrast among exposure characterization methods. Environ Health Perspect. 2010 Jun;118(6):803-11. doi: 10.1289/ehp.0901182. Epub 2010 Feb 2.
citation: Henkin S, Tucker KL, Gao X, Falcon LM, Qawi I, Brugge D. Association of depression, psycho-social stress and acculturation with respiratory disease among Puerto Rican adults in Massachusetts. J Immigr Minor Health. 2011 Apr;13(2):214-23. doi: 10.1007/s10903-009-9307-y.
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citation: Ye X, Lai CQ, Crott JW, Troen AM, Ordovas JM, Tucker KL. The folate hydrolase 1561C>T polymorphism is associated with depressive symptoms in Puerto Rican adults. Psychosom Med. 2011 Jun;73(5):385-92. doi: 10.1097/PSY.0b013e31821a1ab4. Epub 2011 May 19.
citation: Huang T, Tucker KL, Lee YC, Crott JW, Parnell LD, Shen J, Smith CE, Ordovas JM, Li D, Lai CQ. Interactions between genetic variants of folate metabolism genes and lifestyle affect plasma homocysteine concentrations in the Boston Puerto Rican population. Public Health Nutr. 2011 Oct;14(10):1805-12. doi: 10.1017/S1368980011000140. Epub 2011 Feb 22.
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citation: Bhupathiraju SN, Lichtenstein AH, Dawson-Hughes B, Tucker KL. Adherence index based on the AHA 2006 diet and lifestyle recommendations is associated with select cardiovascular disease risk factors in older Puerto Ricans. J Nutr. 2011 Mar;141(3):460-9. doi: 10.3945/jn.110.133603. Epub 2011 Jan 26.
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citation: Moorthy D, Peter I, Scott TM, Parnell LD, Lai CQ, Crott JW, Ordovas JM, Selhub J, Griffith J, Rosenberg IH, Tucker KL, Troen AM. Status of vitamins B-12 and B-6 but not of folate, homocysteine, and the methylenetetrahydrofolate reductase C677T polymorphism are associated with impaired cognition and depression in adults. J Nutr. 2012 Aug;142(8):1554-60. doi: 10.3945/jn.112.161828. Epub 2012 Jun 27.
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citation: Smith CE, Tucker KL, Lee YC, Lai CQ, Parnell LD, Ordovas JM. Low-density lipoprotein receptor-related protein 1 variant interacts with saturated fatty acids in Puerto Ricans. Obesity (Silver Spring). 2013 Mar;21(3):602-8. doi: 10.1002/oby.20001.
citation: Ma XY, Qiu WQ, Smith CE, Parnell LD, Jiang ZY, Ordovas JM, Tucker KL, Lai CQ. Association between BDNF rs6265 and obesity in the Boston Puerto Rican Health Study. J Obes. 2012;2012:102942. doi: 10.1155/2012/102942. Epub 2012 Dec 27.
citation: Van Rompay MI, McKeown NM, Castaneda-Sceppa C, Ordovas JM, Tucker KL. Carbohydrate nutrition differs by diabetes status and is associated with dyslipidemia in Boston Puerto Rican adults without diabetes. J Nutr. 2013 Feb;143(2):182-8. doi: 10.3945/jn.112.168914. Epub 2012 Dec 26.
citation: Todorova IL, Tucker KL, Jimenez MP, Lincoln AK, Arevalo S, Falcon LM. Determinants of self-rated health and the role of acculturation: implications for health inequalities. Ethn Health. 2013;18(6):563-85. doi: 10.1080/13557858.2013.771147. Epub 2013 Feb 21.
citation: Zheng JS, Arnett DK, Parnell LD, Lee YC, Ma Y, Smith CE, Richardson K, Li D, Borecki IB, Ordovas JM, Tucker KL, Lai CQ. Genetic variants at PSMD3 interact with dietary fat and carbohydrate to modulate insulin resistance. J Nutr. 2013 Mar;143(3):354-61. doi: 10.3945/jn.112.168401. Epub 2013 Jan 9.
citation: Mattei J, Bhupathiraju S, Tucker KL. Higher adherence to a diet score based on American Heart Association recommendations is associated with lower odds of allostatic load and metabolic syndrome in Puerto Rican adults. J Nutr. 2013 Nov;143(11):1753-9. doi: 10.3945/jn.113.180141. Epub 2013 Sep 4.
citation: Zheng JS, Arnett DK, Parnell LD, Smith CE, Li D, Borecki IB, Tucker KL, Ordovas JM, Lai CQ. Modulation by dietary fat and carbohydrate of IRS1 association with type 2 diabetes traits in two populations of different ancestries. Diabetes Care. 2013 Sep;36(9):2621-7. doi: 10.2337/dc12-2607. Epub 2013 Apr 17.
citation: Zheng JS, Arnett DK, Parnell LD, Lee YC, Ma Y, Smith CE, Richardson K, Li D, Borecki IB, Tucker KL, Ordovas JM, Lai CQ. Polyunsaturated Fatty Acids Modulate the Association between PIK3CA-KCNMB3 Genetic Variants and Insulin Resistance. PLoS One. 2013 Jun 27;8(6):e67394. doi: 10.1371/journal.pone.0067394. Print 2013.
citation: Bhupathiraju SN, Lichtenstein AH, Dawson-Hughes B, Hannan MT, Tucker KL. Adherence to the 2006 American Heart Association Diet and Lifestyle Recommendations for cardiovascular disease risk reduction is associated with bone health in older Puerto Ricans. Am J Clin Nutr. 2013 Nov;98(5):1309-16. doi: 10.3945/ajcn.112.056267. Epub 2013 Sep 18.
citation: Smith CE, Tucker KL, Arnett DK, Noel SE, Corella D, Borecki IB, Feitosa MF, Aslibekyan S, Parnell LD, Lai CQ, Lee YC, Ordovas JM. Apolipoprotein A2 polymorphism interacts with intakes of dairy foods to influence body weight in 2 U.S. populations. J Nutr. 2013 Dec;143(12):1865-71. doi: 10.3945/jn.113.179051. Epub 2013 Oct 9.
citation: Jamal-Allial A, Griffith JL, Tucker KL. The longitudinal association of vitamin D serum concentrations & adiposity phenotype. J Steroid Biochem Mol Biol. 2014 Oct;144 Pt A:185-8. doi: 10.1016/j.jsbmb.2013.12.004. Epub 2013 Dec 12.
citation: Zheng JS, Parnell LD, Smith CE, Lee YC, Jamal-Allial A, Ma Y, Li D, Tucker KL, Ordovas JM, Lai CQ. Circulating 25-hydroxyvitamin D, IRS1 variant rs2943641, and insulin resistance: replication of a gene-nutrient interaction in 4 populations of different ancestries. Clin Chem. 2014 Jan;60(1):186-96. doi: 10.1373/clinchem.2013.215251. Epub 2013 Nov 19.
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