Obesity Clinical Trial
Official title:
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Verified date | April 2024 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Investigators will establish a longitudinal cohort of ~3,000 adults >18 years in Port-au-Prince using multistage random sampling, and follow them longitudinally to evaluate the prevalence and incidence of cardiovascular disease risk factors and diseases. Cardiovascular risk factors include hypertension, diabetes, obesity, dyslipidemia, kidney disease, poor diet, cigarette smoking, physical inactivity, and inflammation. Cardiovascular disease include angina and myocardial infarction, heart failure, stroke, and CVD mortality. It is anticipated that hypertension prevalence will be ≥10% in 18-30 year olds, that hypertension incidence will be >10 events/1000 person years. Association of determinants and risk factors with CVD will also be examined. Whole blood, serum, plasma, stool, and urine samples will be biobanked for future studies.
Status | Active, not recruiting |
Enrollment | 3005 |
Est. completion date | August 1, 2028 |
Est. primary completion date | August 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age > or = 18 years, primary residence in the study area of Port-au-Prince (defined as having slept at the household at least once in the past two weeks and considers the household their primary residence with no plans to move in the next 24 months), - able to provide consent for study procedures, - agrees to study procedures, and - willing to be contacted at a new residence if a move occurs Exclusion Criteria: - serious medical conditions or cognitive impairment preventing study participation as judged by research physicians, - unable to speak and understand French or Creole. |
Country | Name | City | State |
---|---|---|---|
Haiti | Les Centres GHESKIO | Port-au-Prince | West |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, National Heart, Lung, and Blood Institute (NHLBI) |
Haiti,
Clermont A, Rouzier V, Pierre JL, Sufra R, Dade E, Preval F, St-Preux S, Deschamps MM, Apollon A, Dupnik K, Metz M, Duffus Y, Sabwa S, Yan LD, Lee MH, Palmer LG, Gerber LM, Pecker MS, Mann SJ, Safford MM, Fitzgerald DW, Pape JW, McNairy ML. High Dietary Sodium, Measured Using Spot Urine Samples, is Associated with Higher Blood Pressure among Young Adults in Haiti. Glob Heart. 2023 Feb 14;18(1):5. doi: 10.5334/gh.1187. eCollection 2023. — View Citation
Clermont A, Sufra R, Pierre JL, Mourra MN, Fox EL, Rouzier V, Dade E, St-Preux S, Inddy J, Erline H, Obed FP, Yan LD, Metz M, Lee MH, Fitzgerald DW, Deschamps MM, Pape JW, McNairy ML. Dietary Risk Factors for Cardiovascular Disease among Low-Income Haitian Adults: Findings from a Population-Based Cohort. Nutrients. 2022 Feb 13;14(4):787. doi: 10.3390/nu14040787. — View Citation
Dade E, Metz M, Pierre JL, Rouzier V, Sufra R, Fox E, Preval F, St-Preux S, Zephir JR 2nd, Ariste W, Rasul R, Sabwa S, Roberts N, Deschamps MM, Severe P, Fitzgerald D, Pape JW, Yan LD, McNairy ML. High prevalence of obesity among women in urban Haiti: Findings from a population-based cohort. Front Public Health. 2022 Oct 5;10:976909. doi: 10.3389/fpubh.2022.976909. eCollection 2022. — View Citation
Kingery JR, Roberts NL, Lookens Pierre J, Sufra R, Dade E, Rouzier V, Malebranche R, Theard M, Goyal P, Pirmohamed A, Yan LD, Hee Lee M, Nash D, Metz M, Peck RN, Safford MM, Fitzgerald D, Deschamps MM, Pape JW, McNairy M. Population-Based Epidemiology of Heart Failure in a Low-Income Country: The Haiti Cardiovascular Disease Cohort. Circ Cardiovasc Qual Outcomes. 2023 Feb;16(2):e009093. doi: 10.1161/CIRCOUTCOMES.122.009093. Epub 2022 Dec 6. — View Citation
Lookens J, Tymejczyk O, Rouzier V, Smith C, Preval F, Joseph I, Baptiste RJ, Victor J, Severe P, Apollon S, Dumont E, Forestal G, St Preux S, Rivera V, Seo G, Charles B, Ariste W, Kingery J, Devieux J, Koenig S, Nash D, Fitzgerald D, Safford M, Deschamps MM, Pape J, McNairy M. The Haiti cardiovascular disease cohort: study protocol for a population-based longitudinal cohort. BMC Public Health. 2020 Nov 1;20(1):1633. doi: 10.1186/s12889-020-09734-x. — View Citation
Metz M, Pierre JL, Yan LD, Rouzier V, St-Preux S, Exantus S, Preval F, Roberts N, Tymejczyk O, Malebranche R, Deschamps MM, Pape JW, McNairy ML. Hypertension continuum of care: Blood pressure screening, diagnosis, treatment, and control in a population-based cohort in Haiti. J Clin Hypertens (Greenwich). 2022 Mar;24(3):246-254. doi: 10.1111/jch.14399. Epub 2022 Feb 24. — View Citation
Rasul R, Rouzier V, Sufra R, Yan LD, Joseph I, Mourra N, Sabwa S, Deschamps MM, Fitzgerald DW, Pape JW, Nash D, McNairy ML. Extreme Food Insecurity and Malnutrition in Haiti: Findings from a Population-Based Cohort in Port-au-Prince, Haiti. Nutrients. 2022 Nov 17;14(22):4854. doi: 10.3390/nu14224854. — View Citation
Roberts NLS, Pierre JL, Rouzier V, Sufra R, St-Preux S, Yan LD, Metz M, Clermont A, Apollon A, Sabwa S, Deschamps MM, Kingery JR, Peck R, Fitzgerald D, Pape JW, Tummalapalli SL, McNairy ML. Prevalence and Severity of Chronic Kidney Disease in Haiti. Clin J Am Soc Nephrol. 2023 Jun 1;18(6):739-747. doi: 10.2215/CJN.0000000000000175. Epub 2023 Apr 18. — View Citation
Smith CE, Metz M, Lookens Pierre J, Rouzier V, Yan LD, Sufra R, Dade E, Preval F, Ariste W, Rivera V, Tymejczyk O, Peck R, Koenig S, Deschamps MM, Pape W, McNairy ML. Comparison of community and clinic-based blood pressure measurements: A cross-sectional study from Haiti. PLOS Glob Public Health. 2022;2(9):e0001064. doi: 10.1371/journal.pgph.0001064. Epub 2022 Sep 30. — View Citation
Sufra R, Lookens Pierre J, Dade E, Rouzier V, Apollon A, St Preux S, Preval F, Inddy J, Metz M, Tymejczyk O, Nash D, Malebranche R, Deschamps M, Pape JW, Goncalves MD, McNairy ML, Yan LD. Diabetes Epidemiology Among Adults in Port-au-Prince, Haiti: A Cross-Sectional Study. Front Endocrinol (Lausanne). 2022 Feb 24;13:841675. doi: 10.3389/fendo.2022.841675. eCollection 2022. — View Citation
Yan LD, Devieux JG, Pierre JL, Dade E, Sufra R, St Preux S, Tymejczyk O, Nash D, Metz M, Lee MH, Fitzgerald DW, Deschamps M, Pape JW, McNairy ML, Rouzier V. The relationship between perceived stress and support with blood pressure in urban Haiti: A cross-sectional analysis. PLOS Glob Public Health. 2022;2(5):e0000263. doi: 10.1371/journal.pgph.0000263. Epub 2022 May 2. — View Citation
Yan LD, Lookens Pierre J, Rouzier V, Theard M, Apollon A, St Preux S, Kingery JR, Jamerson KA, Deschamps M, Pape JW, Safford MM, McNairy ML. Comparing six cardiovascular risk prediction models in Haiti: implications for identifying high-risk individuals for primary prevention. BMC Public Health. 2022 Mar 19;22(1):549. doi: 10.1186/s12889-022-12963-x. — View Citation
Yan LD, McNairy ML, Devieux JG, Pierre JL, Dade E, Sufra R, Gerber LM, Roberts N, St Preux S, Malebranche R, Metz M, Tymejczyk O, Nash D, Deschamps M, Safford MM, Pape JW, Rouzier V. Neighborhood cohesion and violence in Port-au-Prince, Haiti, and their relationship to stress, depression, and hypertension: Findings from the Haiti cardiovascular disease cohort study. PLOS Glob Public Health. 2022;2(7):e0000503. doi: 10.1371/journal.pgph.0000503. Epub 2022 Jul 27. — View Citation
Yan LD, Rouzier V, Pierre JL, Lee MH, Muntner P, Parsons PJ, Apollon A, St-Preux S, Malebranche R, Pierre G, Emmanuel E, Nash D, Kingery J, Walsh KF, Smith CE, Metz M, Tymejczyk O, Deschamps M, Pape JW, Fitzgerald DW, McNairy ML. High Lead Exposure Associated With Higher Blood Pressure in Haiti: a Warning Sign for Low-Income Countries. Hypertension. 2022 Jan;79(1):283-290. doi: 10.1161/HYPERTENSIONAHA.121.18250. Epub 2021 Nov 17. — View Citation
Yan LD, Sufra R, St Sauveur R, Jean-Pierre MC, Apollon A, Malebranche R, Theard M, Pierre G, Devieux J, Lau J, Mourra N, Roberts NLS, Rasul R, Nash D, Pirmohamed AM, Devereux RB, Lee MH, Kwan GF, Safford MM, Adrien L, Alfred JP, Deschamps M, Severe P, Fitzgerald DW, Pape JW, Rouzier V, McNairy ML; Haiti Cardiovascular Disease Cohort study team. Spectrum of prevalent cardiovascular diseases in urban Port-au-Prince, Haiti: a population-based cross-sectional study. Lancet Reg Health Am. 2024 Apr 4;33:100729. doi: 10.1016/j.lana.2024.100729. eCollection 2024 May. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of CVD risk factors and diseases and their association with social and environmental determinants in an established longitudinal cohort of ~3,000 Haitian adults | The prevalence of CVD risk factors including HTN, diabetes, obesity, cigarette smoking, dyslipidemia, kidney disease, poor diet, physical inactivity, and inflammation will be calculated. Prevalence will be reported for categorical risk factors (e.g., HTN), and mean and standard deviation will be estimated for continuous risk factors (e.g., BP, lipid levels). The research team will also estimate the prevalence of each CVD outcome including MI, HF, and stroke. | Baseline | |
Secondary | Incidence of CVD risk factors and CVD during ~7 years of follow-up and their association with social and environmental determinants | Investigators will calculate the incidence rate of each CVD risk factor per 1000 person years (PY) of follow-up among participants without the respective CVD risk factor at baseline using a Horvitz-Thompson type estimator accounting for unequal sampling weights. Similarly, investigators will calculate the incidence rate of each CVD outcome among participants without the respective CVD at baseline. | Participants will be followed for ~7 years |
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