xml: <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/NCT05973760</url>
    </required_header>
    <id_info>
      <org_study_id>FREC 2023-0484-572</org_study_id>
      <secondary_id>RSUTH/REC/2023316</secondary_id>
      <nct_id>NCT05973760</nct_id>
    </id_info>
    <brief_title>Dietary Assessment and Prevention of Hypertension in Nigeria</brief_title>
    <official_title>Dietary Assessment and Prevention of Hypertension in Nigeria</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Leeds</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Rivers State University Teaching Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tertiary Education Trust Fund (TETFund)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Leeds</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>
        Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa&#xD;
        and, currently, there are no simple dietary assessment tools for clinicians to offer&#xD;
        personalized dietary support to their patients. This study aims to:&#xD;
  &#xD;
          1. Evaluate the feasibility and validate the a short dietary screening tool for&#xD;
             hypertension for use in Nigerian clinics; and&#xD;
  &#xD;
          2. Test the accuracy and estimate the potential value of the validated short dietary&#xD;
             assessment tool in Nigeria clinics.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Contrary to North America and Europe, the prevalence of hypertension is rising in West&#xD;
        Africa. With a transition from whole foods to processed foods in Nigeria, diet is considered&#xD;
        a key driver of hypertension. To combat this, the national nutritional guidelines in Nigeria&#xD;
        were implemented but their translation into actionable tools for clinicians remains a&#xD;
        challenge. Currently, there are no simple dietary assessment tools that are concise and&#xD;
        suitable to be incorporated into clinical care without requiring extensive data analysis&#xD;
        while still providing personalized dietary support to their patients. This study aims to&#xD;
        deliver a clinically tested and validated short dietary assessment tool for clinicians,&#xD;
        patients, and researchers across Nigeria to provide personalised dietary advice for patients&#xD;
        with hypertension.&#xD;
  &#xD;
        The study will be conducted in two phases: Phase 1 (n=75), will investigate the feasibility&#xD;
        of the short FFQ and its agreement with 24-hour dietary recalls (3x) in a clinical setting in&#xD;
        Nigeria. During the analysis of Phase 1 data, a scoring system will be developed based on the&#xD;
        associations between individual food items in the FFQ and measures of hypertension. Phase 2&#xD;
        (n=50) will assess the acceptability of the FFQ and validate the association between the FFQ&#xD;
        score and hypertension.&#xD;
  &#xD;
        We anticipate that the development of a clinically tested and validated short food frequency&#xD;
        questionnaire that will be ready for implementation analysis for use by clinicians, patients,&#xD;
        and researchers across Nigerian that will support the prevention and management of&#xD;
        hypertension.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 23, 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Validity of Clinical food frequency questionnaire (FFQ)</measure>
      <time_frame>Phase 1 (4-8 weeks)</time_frame>
      <description>Demonstrate the ability of a novel short clinical FFQ to accurately reflect diet habits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of FFQ clinical tool in Nigerian clinic</measure>
      <time_frame>Phase1 (4-8 weeks) and Phase 2 (4-8 weeks)</time_frame>
      <description>Do patients, clinicians, and nurses see value in the tool in a clinical setting and accepting of it's use in the clinic</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hypertension/Blood Pressure</measure>
      <time_frame>Phase 2 (4 - 8 weeks)</time_frame>
      <description>Association between FFQ clinical tool and blood pressure</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">125</enrollment>
    <condition>Hypertension</condition>
    <condition>Blood Pressure</condition>
    <arm_group>
      <arm_group_label>Hypertensive</arm_group_label>
      <description>Men or women previously diagnosed with hypertension</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-hypertensive</arm_group_label>
      <description>Men or women not previously diagnosed with hypertension</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Men and women deciding in Nigeria visiting River State University Teaching Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men and women of generally good health or with hypertension&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  history of chronic diseases such as cardiovascular diseases (heart diseases), stroke,&#xD;
               chronic kidney diseases, or pregnant or breastfeeding women, children below 18 years&#xD;
               and adults above 70 years are also excluded from this study. Additionally, individuals&#xD;
               who have made significant changes to their diet in the past six months or are&#xD;
               currently following specific dietary restrictions will also be excluded from this&#xD;
               study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael Zulyniak, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Leeds</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nimisoere Batubo, MMBS</last_name>
      <phone>01782 715444</phone>
      <email>fsnpb@leeds.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Michael Zulyniak, PhD</last_name>
      <email>prcmaz@leeds.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Royal State University</name>
        <address>
          <city>Port Harcourt</city>
          <country>Nigeria</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michael Zulyniak, PhD</last_name>
        <email>prcmaz@leeds.ac.uk</email>
      </contact>
      <contact_backup>
        <last_name>Nimisoere Batubo, MBBS</last_name>
        <email>fsnpb@leeds.ac.uk</email>
      </contact_backup>
      <investigator>
        <last_name>Michael Zulyniak, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nimisoere Batubo, MMBS</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Nigeria</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Leeds</investigator_affiliation>
      <investigator_full_name>Michael A Zulyniak</investigator_full_name>
      <investigator_title>Dr.</investigator_title>
    </responsible_party>
    <keyword>diet</keyword>
    <keyword>West Africa</keyword>
    <keyword>nutrition</keyword>
    <keyword>LMIC</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There are no plans to share individual participant data</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 19, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT05973760/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973760
  org study id: FREC 2023-0484-572
  secondary id: RSUTH/REC/2023316
  nct id: NCT05973760
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa
        and, currently, there are no simple dietary assessment tools for clinicians to offer
        personalized dietary support to their patients. This study aims to:
  
          1. Evaluate the feasibility and validate the a short dietary screening tool for
             hypertension for use in Nigerian clinics; and
  
          2. Test the accuracy and estimate the potential value of the validated short dietary
             assessment tool in Nigeria clinics.
  Contrary to North America and Europe, the prevalence of hypertension is rising in West
        Africa. With a transition from whole foods to processed foods in Nigeria, diet is considered
        a key driver of hypertension. To combat this, the national nutritional guidelines in Nigeria
        were implemented but their translation into actionable tools for clinicians remains a
        challenge. Currently, there are no simple dietary assessment tools that are concise and
        suitable to be incorporated into clinical care without requiring extensive data analysis
        while still providing personalized dietary support to their patients. This study aims to
        deliver a clinically tested and validated short dietary assessment tool for clinicians,
        patients, and researchers across Nigeria to provide personalised dietary advice for patients
        with hypertension.
  
        The study will be conducted in two phases: Phase 1 (n=75), will investigate the feasibility
        of the short FFQ and its agreement with 24-hour dietary recalls (3x) in a clinical setting in
        Nigeria. During the analysis of Phase 1 data, a scoring system will be developed based on the
        associations between individual food items in the FFQ and measures of hypertension. Phase 2
        (n=50) will assess the acceptability of the FFQ and validate the association between the FFQ
        score and hypertension.
  
        We anticipate that the development of a clinically tested and validated short food frequency
        questionnaire that will be ready for implementation analysis for use by clinicians, patients,
        and researchers across Nigerian that will support the prevention and management of
        hypertension.
  observational model: Case-Control
  time perspective: Other
  measure: Validity of Clinical food frequency questionnaire (FFQ)
  time frame: Phase 1 (4-8 weeks)
  description: Demonstrate the ability of a novel short clinical FFQ to accurately reflect diet habits
  measure: Feasibility of FFQ clinical tool in Nigerian clinic
  time frame: Phase1 (4-8 weeks) and Phase 2 (4-8 weeks)
  description: Do patients, clinicians, and nurses see value in the tool in a clinical setting and accepting of it's use in the clinic
  measure: Hypertension/Blood Pressure
  time frame: Phase 2 (4 - 8 weeks)
  description: Association between FFQ clinical tool and blood pressure
  arm group label: Hypertensive
  description: Men or women previously diagnosed with hypertension
  arm group label: Non-hypertensive
  description: Men or women not previously diagnosed with hypertension
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Michael Zulyniak, PhD
  role: Principal Investigator
  affiliation: University of Leeds
  last name: Nimisoere Batubo, MMBS
  phone: 01782 715444
  email: fsnpb@leeds.ac.uk
  last name: Michael Zulyniak, PhD
  email: prcmaz@leeds.ac.uk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Nigeria
  responsible party type: Principal Investigator
  investigator affiliation: University of Leeds
  investigator full name: Michael A Zulyniak
  investigator title: Dr.
  mesh term: Hypertension
  sharing ipd: No
  ipd description: There are no plans to share individual participant data
  provided document: 