<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03794531</url>
  </required_header>
  <id_info>
    <org_study_id>143792</org_study_id>
    <secondary_id>R01HL143792</secondary_id>
    <secondary_id>R21MD013650</secondary_id>
    <nct_id>NCT03794531</nct_id>
  </id_info>
  <brief_title>Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico</brief_title>
  <acronym>PROSPECT</acronym>
  <official_title>Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>FDI Clinical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Massachusetts, Lowell</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Puerto Rico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Harvard School of Public Health (HSPH)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal is to identify trends and longitudinal associations in psychosocial,&#xD;
      food-related, and cardiometabolic risk factors that can guide public health priorities and&#xD;
      future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To&#xD;
      this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of&#xD;
      Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal&#xD;
      population cohort of 2,000 adults (30-75 years) in PR recruited with a community-wide&#xD;
      sampling strategy, and assessed in a network of several partner clinics across the island.&#xD;
      The study will collect comprehensive data on multiple psychosocial, dietary, and food-related&#xD;
      factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will&#xD;
      assess variations by urban-rural area and by timing before-after Maria.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with self-reported medically-diagnosed chronic diseases</measure>
    <time_frame>4 years</time_frame>
    <description>Estimate the prevalence and incidence of chronic diseases (and their dietary and psychosocial risk factors)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in the number of participants with self-reported medically-diagnosed chronic diseases living urban vs. rural area</measure>
    <time_frame>4 years</time_frame>
    <description>Estimate differences in prevalence and changes in chronic diseases (and their dietary and psychosocial risk factors) in urban vs. rural area</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Risk of clinically-measured metabolic syndrome (e.g. high blood pressure, elevated adiposity, elevated blood glucose, and out-of-normal-range blood lipids), according to dietary and psychosocial risk factors</measure>
    <time_frame>4 years</time_frame>
    <description>Determine risk of biological metabolic risk factors by changes in psychosocial factors or diet-related factors</description>
  </other_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Heart Diseases</condition>
  <condition>Type2 Diabetes</condition>
  <condition>Hypertension</condition>
  <condition>Obesity</condition>
  <condition>Dyslipidemias</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Chronic Disease</condition>
  <condition>Inflammation</condition>
  <condition>Psychological Stress</condition>
  <condition>Physiological Stress</condition>
  <condition>Depressive Symptoms</condition>
  <condition>Coping Behavior</condition>
  <condition>Diet Habit</condition>
  <condition>Lifestyle</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, urine, saliva, hair.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Convenience community-wide sample of eligible adults living in all of Puerto Rico.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 30-75 years old at the time of enrollment&#xD;
&#xD;
          2. Non-institutionalized&#xD;
&#xD;
          3. Living in PR at the time of the first interview and the year before and not planning&#xD;
             to move from the island within 3 years&#xD;
&#xD;
          4. Able to answer questions without assistance&#xD;
&#xD;
          5. Living in a stable dwelling&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Josiemer Mattei, PhD</last_name>
    <phone>6174323017</phone>
    <email>jmattei@hsph.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martha Tamez, ScD</last_name>
    <phone>6174323017</phone>
    <email>m.tamez@mail.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>FDI Clinical Research</name>
      <address>
        <city>San Juan</city>
        <zip>00926</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sigrid Mendoza, PhD</last_name>
      <phone>7877221248</phone>
      <phone_ext>246</phone_ext>
      <email>smendoza@fdipr.com</email>
    </contact>
    <contact_backup>
      <last_name>Jonathan Orozco, MS</last_name>
      <phone>7877221248</phone>
      <phone_ext>271</phone_ext>
      <email>jorozco@fdipr.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jose F Rodriguez-Orengo, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
  </location_countries>
  <link>
    <url>https://www.hsph.harvard.edu/prospect/</url>
    <description>Study website</description>
  </link>
  <link>
    <url>https://www.facebook.com/study.prospectpr</url>
    <description>Facebook page</description>
  </link>
  <reference>
    <citation>Mattei J, Tucker KL, Falcon LM, Rios-Bedoya CF, Kaplan RM, O'Neill HJ, Tamez M, Mendoza S, Diaz-Alvarez CB, Orozco JE, Acosta Perez E, Rodriguez-Orengo JF. Design and Implementation of the Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends (PROSPECT). Am J Epidemiol. 2021 May 4;190(5):707-717. doi: 10.1093/aje/kwaa231.</citation>
    <PMID>33083832</PMID>
  </reference>
  <results_reference>
    <citation>Mattei J, Tamez M, O'Neill J, Haneuse S, Mendoza S, Orozco J, Lopez-Cepero A, Rios-Bedoya CF, Falcon LM, Tucker KL, Rodriguez-Orengo JF. Chronic Diseases and Associated Risk Factors Among Adults in Puerto Rico After Hurricane Maria. JAMA Netw Open. 2022 Jan 4;5(1):e2139986. doi: 10.1001/jamanetworkopen.2021.39986.</citation>
    <PMID>35019984</PMID>
  </results_reference>
  <results_reference>
    <citation>Lopez-Cepero A, O'Neill HJ, Marrero A, Falcon LM, Tamez M, Rodriguez-Orengo JF, Mattei J. Association between adverse experiences during Hurricane Maria and mental and emotional distress among adults in Puerto Rico. Soc Psychiatry Psychiatr Epidemiol. 2022 Dec;57(12):2423-2432. doi: 10.1007/s00127-022-02355-2. Epub 2022 Sep 1.</citation>
    <PMID>36048184</PMID>
  </results_reference>
  <results_reference>
    <citation>Xu W, Lopez-Cepero A, O'Neill HJ, Plym A, Austin SB, Mattei J. Food Insecurity Is Associated With Dysfunctional Eating Behaviors Among Adults in Puerto Rico. J Nutr Educ Behav. 2023 Sep;55(9):644-650. doi: 10.1016/j.jneb.2023.05.255. Epub 2023 Jul 1.</citation>
    <PMID>37395692</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard School of Public Health (HSPH)</investigator_affiliation>
    <investigator_full_name>Josiemer Mattei</investigator_full_name>
    <investigator_title>Associate Professor of Nutrition</investigator_title>
  </responsible_party>
  <keyword>Hispanics/Latinos</keyword>
  <keyword>Minority health</keyword>
  <keyword>Puerto Rico</keyword>
  <keyword>Cardiovascular disease</keyword>
  <keyword>Cardiometabolic health</keyword>
  <keyword>Chronic disease risk factors</keyword>
  <keyword>Disaster research</keyword>
  <keyword>Caribbean and Latin America</keyword>
  <keyword>Population health</keyword>
  <keyword>Prospective study</keyword>
  <keyword>Allostatic load</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be managed and distributed observing NIH and IRB policies on the dissemination and sharing of research results. Study information and requests for data will be available immediately upon the data being de-identified and properly revised for quality control on the study website.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>2-years</ipd_time_frame>
    <ipd_access_criteria>The requested data will be shared with investigators via a secured, password-protected software website.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03794531
org study id: 143792
secondary id: R01HL143792
secondary id: R21MD013650
nct id: NCT03794531
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall goal is to identify trends and longitudinal associations in psychosocial,
      food-related, and cardiometabolic risk factors that can guide public health priorities and
      future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To
      this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of
      Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal
      population cohort of 2,000 adults (30-75 years) in PR recruited with a community-wide
      sampling strategy, and assessed in a network of several partner clinics across the island.
      The study will collect comprehensive data on multiple psychosocial, dietary, and food-related
      factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will
      assess variations by urban-rural area and by timing before-after Maria.
observational model: Cohort
time perspective: Prospective
measure: Number of participants with self-reported medically-diagnosed chronic diseases
time frame: 4 years
description: Estimate the prevalence and incidence of chronic diseases (and their dietary and psychosocial risk factors)
measure: Difference in the number of participants with self-reported medically-diagnosed chronic diseases living urban vs. rural area
time frame: 4 years
description: Estimate differences in prevalence and changes in chronic diseases (and their dietary and psychosocial risk factors) in urban vs. rural area
measure: Risk of clinically-measured metabolic syndrome (e.g. high blood pressure, elevated adiposity, elevated blood glucose, and out-of-normal-range blood lipids), according to dietary and psychosocial risk factors
time frame: 4 years
description: Determine risk of biological metabolic risk factors by changes in psychosocial factors or diet-related factors
Blood, urine, saliva, hair.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Josiemer Mattei, PhD
phone: 6174323017
email: jmattei@hsph.harvard.edu
last name: Martha Tamez, ScD
phone: 6174323017
email: m.tamez@mail.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Puerto Rico
url: https://www.hsph.harvard.edu/prospect/
description: Study website
url: https://www.facebook.com/study.prospectpr
description: Facebook page
citation: Mattei J, Tucker KL, Falcon LM, Rios-Bedoya CF, Kaplan RM, O'Neill HJ, Tamez M, Mendoza S, Diaz-Alvarez CB, Orozco JE, Acosta Perez E, Rodriguez-Orengo JF. Design and Implementation of the Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends (PROSPECT). Am J Epidemiol. 2021 May 4;190(5):707-717. doi: 10.1093/aje/kwaa231.
PMID: 33083832
citation: Mattei J, Tamez M, O'Neill J, Haneuse S, Mendoza S, Orozco J, Lopez-Cepero A, Rios-Bedoya CF, Falcon LM, Tucker KL, Rodriguez-Orengo JF. Chronic Diseases and Associated Risk Factors Among Adults in Puerto Rico After Hurricane Maria. JAMA Netw Open. 2022 Jan 4;5(1):e2139986. doi: 10.1001/jamanetworkopen.2021.39986.
PMID: 35019984
citation: Lopez-Cepero A, O'Neill HJ, Marrero A, Falcon LM, Tamez M, Rodriguez-Orengo JF, Mattei J. Association between adverse experiences during Hurricane Maria and mental and emotional distress among adults in Puerto Rico. Soc Psychiatry Psychiatr Epidemiol. 2022 Dec;57(12):2423-2432. doi: 10.1007/s00127-022-02355-2. Epub 2022 Sep 1.
PMID: 36048184
citation: Xu W, Lopez-Cepero A, O'Neill HJ, Plym A, Austin SB, Mattei J. Food Insecurity Is Associated With Dysfunctional Eating Behaviors Among Adults in Puerto Rico. J Nutr Educ Behav. 2023 Sep;55(9):644-650. doi: 10.1016/j.jneb.2023.05.255. Epub 2023 Jul 1.
PMID: 37395692
responsible party type: Principal Investigator
investigator affiliation: Harvard School of Public Health (HSPH)
investigator full name: Josiemer Mattei
investigator title: Associate Professor of Nutrition
mesh term: Cardiovascular Diseases
mesh term: Heart Diseases
mesh term: Metabolic Syndrome
mesh term: Dyslipidemias
mesh term: Inflammation
mesh term: Chronic Disease
mesh term: Depression
mesh term: Stress, Psychological
sharing ipd: Yes
ipd description: IPD will be managed and distributed observing NIH and IRB policies on the dissemination and sharing of research results. Study information and requests for data will be available immediately upon the data being de-identified and properly revised for quality control on the study website.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: 2-years
ipd access criteria: The requested data will be shared with investigators via a secured, password-protected software website.