<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/NCT03250702</url>
  </required_header>
  <id_info>
    <org_study_id>IRB13-0852</org_study_id>
    <nct_id>NCT03250702</nct_id>
  </id_info>
  <brief_title>DUCS-DHD Determinants of Hypertension in Tanzania</brief_title>
  <acronym>DUCS-HTN</acronym>
  <official_title>Dar es Salaam Urban Cohort Hypertension Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Muhimbili University of Health and Allied Sciences</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 aim of the Dar es Salaam Urban Cohort Hypertension Study (DUCS-HTN) was to determine the&#xD;
      current prevalence, risk factors, and barriers to diagnosis and treatment for hypertension in&#xD;
      Dar es Salaam, Tanzania. Few previous studies in Tanzania have analyzed the modifiable&#xD;
      determinants of high BP as well as barriers to diagnosis and treatment of hypertension.&#xD;
&#xD;
      DUCS-HTN is a cohort of adults living in the Ukonga ward of Dar es Salaam who had been&#xD;
      registered in the Dar es Salaam Health and Demographic Surveillance System (HDSS) in 2011.&#xD;
      Due to the large size of Ukonga, the investigators chose to randomly sample two of the seven&#xD;
      neighborhoods that compose Ukonga and then conducted a census of these two randomly selected&#xD;
      neighborhoods, Mwembe Madafu and Markazi. The investigators attempted to contact all 4896&#xD;
      HDSS participants who were at least 40 years of age and lived in one of these neighborhoods.&#xD;
&#xD;
      Trained interviewers conducted face-to-face interviews and physical examinations in&#xD;
      participants' homes from March to June 2014. Follow-up visits were conducted from April to&#xD;
      June 2015.&#xD;
&#xD;
      Among 4896 potentially eligible participants from the HDSS baseline survey, 3604 (74%) were&#xD;
      still living at the same address in 2014. Of these, 2290 (64%) enrolled in the DUCS-HTN&#xD;
      study. Of the participants enrolled at baseline, 1752 (77%) participated in the follow-up&#xD;
      study.&#xD;
&#xD;
      Blood pressure measurements&#xD;
&#xD;
      Trained interviewers measured blood pressure with digital blood pressure monitors (15 Omron&#xD;
      M2 and 5 Beurer BM 40 monitors). Standard, large, and extra-large cuff sizes were used&#xD;
      according to the size of a participant's arm. Blood pressure was measured three times with at&#xD;
      least a 5-minute rest before the first measurement and 3-minute rests between each subsequent&#xD;
      measurement. Blood pressure was taken on the left arm with the participant seated and the arm&#xD;
      straight at heart level. Usual blood pressure values were calculated as the mean of the&#xD;
      second and third readings. If a second visit was conducted, usual blood pressure values were&#xD;
      defined as the mean of the second and third readings at both the first and second visits.&#xD;
&#xD;
      Hypertension was defined as SBP≥140 mmHg or DBP≥90 mmHg, or self-reported use of&#xD;
      anti-hypertensive medication. Grade I hypertension was defined as SBP of 140 to 159 or DBP of&#xD;
      90 to 99 mmHg; grade II hypertension was defined as SBP of 160 to 179 or DBP of 100 to 109&#xD;
      mmHg; and grade III hypertension was defined as SBP≥180 or DBP≥110 mmHg. Hypertension control&#xD;
      was defined as current antihypertensive use and blood pressure of less than 140/90 mmHg. If a&#xD;
      participant was found to have grade I or II hypertension, a second visit was scheduled, at&#xD;
      least three days later. Those with grade III hypertension at the last reading of the first&#xD;
      visit or grade I or II hypertension at the last reading of the second visit were told that&#xD;
      they had high blood pressure, advised to see a health professional and were given a referral&#xD;
      letter. In addition, a second visit and blood pressure reading was scheduled for a random&#xD;
      sample of one-fifth of participants, who were selected for additional blood, urinary, and&#xD;
      dietary measurements.&#xD;
&#xD;
      Assessment of covariates&#xD;
&#xD;
      All participants were administered a socio-demographic and lifestyle questionnaire and had&#xD;
      their height, weight, and waist and hip circumference measured. Some demographic information&#xD;
      (age, sex, neighborhood, religion, and assets used to create a household wealth index) was&#xD;
      previously recorded during the HDSS baseline. Information on household health insurance&#xD;
      coverage was collected in 2015 as part of routine HDSS updates.&#xD;
&#xD;
      Standard protocols were used to take anthropometric measurements. Participants were weighed&#xD;
      with minimal clothing using a digital scale (Seca, Germany) to the nearest 0.1kg and height&#xD;
      was measured, with participants not wearing shoes, to the nearest 1cm. Body mass index (BMI)&#xD;
      was calculated as the ratio of weight in kilograms to height in meters squared (kg/m2) and&#xD;
      categorized according to WHO categories.&#xD;
&#xD;
      The Global Physical Activity Questionnaire (GPAQ) was used to assess physical activity for&#xD;
      work, transportation, and leisure. The investigators defined physical inactivity according to&#xD;
      WHO guidelines. Number of servings of alcoholic beverages consumed was reported over the past&#xD;
      30 days. The investigators assumed 14 grams of alcohol as a standard drink portion size. A&#xD;
      household wealth index was created through a principal component analysis of household&#xD;
      characteristics and assets, and was categorized into quintiles. In the follow-up visit,&#xD;
      participants were asked about their health over the past year and the reasons for not seeking&#xD;
      hypertension care.&#xD;
&#xD;
      A subsample of ~ one fifth of the participants completed a food frequency questionnaire, two&#xD;
      24-hour dietary recalls, a 24-hour urine collection for sodium, creatinine, protein, and&#xD;
      potassium, and had capillary total cholesterol and blood glucose measurements taken.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Systolic blood pressure</measure>
    <time_frame>baseline</time_frame>
    <description>Continuous variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visited health professional for hypertension care</measure>
    <time_frame>1-year follow-up</time_frame>
    <description>Self report of visiting health professional for hypertension care between baseline and follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Taking antihypertensive medication</measure>
    <time_frame>1-year follow-up</time_frame>
    <description>Self report of taking antihypertensive treatment at time of follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertension</measure>
    <time_frame>baseline</time_frame>
    <description>SBP &gt;=140 or DBP &gt;=90 or using antihypertensive medication</description>
  </secondary_outcome>
  <enrollment type="Actual">2290</enrollment>
  <condition>Hypertension</condition>
  <condition>Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        DUCS-HTN is a cohort of adults living in the Ukonga ward of Dar es Salaam who had been&#xD;
        registered in the Dar es Salaam Health and Demographic Surveillance System (HDSS) in 2011.&#xD;
        Due to the large size of Ukonga, we chose to randomly sample two of the seven neighborhoods&#xD;
        that compose Ukonga and then conducted a census of these two randomly selected&#xD;
        neighborhoods, Mwembe Madafu and Markazi. We attempted to contact all 4896 HDSS&#xD;
        participants who were at least 40 years of age and lived in one of these neighborhoods.&#xD;
&#xD;
        Trained interviewers conducted face-to-face interviews and physical examinations in&#xD;
        participants' homes from March to June 2014. Follow-up visits were conducted from April to&#xD;
        June 2015.&#xD;
&#xD;
        Among 4896 potentially eligible participants from the HDSS baseline survey, 3604 (74%) were&#xD;
        still living at the same address in 2014. Of these, 2290 (64%) enrolled in the DUCS-HTN&#xD;
        study. Of the participants enrolled at baseline, 1752 (77%) participated in the follow-up&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lived in Madafu or Markazi neighborhoods of Ukonga Ward in Tanzania&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Mentally or physically disabled&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</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>Goodarz Danaei</investigator_full_name>
    <investigator_title>Associate Professor of Global Health</investigator_title>
  </responsible_party>
  <keyword>Tanzania</keyword>
  <keyword>Observational</keyword>
  <keyword>Sub-Saharan Africa</keyword>
  <keyword>Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT03250702
org study id: IRB13-0852
nct id: NCT03250702
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the Dar es Salaam Urban Cohort Hypertension Study (DUCS-HTN) was to determine the
      current prevalence, risk factors, and barriers to diagnosis and treatment for hypertension in
      Dar es Salaam, Tanzania. Few previous studies in Tanzania have analyzed the modifiable
      determinants of high BP as well as barriers to diagnosis and treatment of hypertension.

      DUCS-HTN is a cohort of adults living in the Ukonga ward of Dar es Salaam who had been
      registered in the Dar es Salaam Health and Demographic Surveillance System (HDSS) in 2011.
      Due to the large size of Ukonga, the investigators chose to randomly sample two of the seven
      neighborhoods that compose Ukonga and then conducted a census of these two randomly selected
      neighborhoods, Mwembe Madafu and Markazi. The investigators attempted to contact all 4896
      HDSS participants who were at least 40 years of age and lived in one of these neighborhoods.

      Trained interviewers conducted face-to-face interviews and physical examinations in
      participants' homes from March to June 2014. Follow-up visits were conducted from April to
      June 2015.

      Among 4896 potentially eligible participants from the HDSS baseline survey, 3604 (74%) were
      still living at the same address in 2014. Of these, 2290 (64%) enrolled in the DUCS-HTN
      study. Of the participants enrolled at baseline, 1752 (77%) participated in the follow-up
      study.

      Blood pressure measurements

      Trained interviewers measured blood pressure with digital blood pressure monitors (15 Omron
      M2 and 5 Beurer BM 40 monitors). Standard, large, and extra-large cuff sizes were used
      according to the size of a participant's arm. Blood pressure was measured three times with at
      least a 5-minute rest before the first measurement and 3-minute rests between each subsequent
      measurement. Blood pressure was taken on the left arm with the participant seated and the arm
      straight at heart level. Usual blood pressure values were calculated as the mean of the
      second and third readings. If a second visit was conducted, usual blood pressure values were
      defined as the mean of the second and third readings at both the first and second visits.

      Hypertension was defined as SBP≥140 mmHg or DBP≥90 mmHg, or self-reported use of
      anti-hypertensive medication. Grade I hypertension was defined as SBP of 140 to 159 or DBP of
      90 to 99 mmHg; grade II hypertension was defined as SBP of 160 to 179 or DBP of 100 to 109
      mmHg; and grade III hypertension was defined as SBP≥180 or DBP≥110 mmHg. Hypertension control
      was defined as current antihypertensive use and blood pressure of less than 140/90 mmHg. If a
      participant was found to have grade I or II hypertension, a second visit was scheduled, at
      least three days later. Those with grade III hypertension at the last reading of the first
      visit or grade I or II hypertension at the last reading of the second visit were told that
      they had high blood pressure, advised to see a health professional and were given a referral
      letter. In addition, a second visit and blood pressure reading was scheduled for a random
      sample of one-fifth of participants, who were selected for additional blood, urinary, and
      dietary measurements.

      Assessment of covariates

      All participants were administered a socio-demographic and lifestyle questionnaire and had
      their height, weight, and waist and hip circumference measured. Some demographic information
      (age, sex, neighborhood, religion, and assets used to create a household wealth index) was
      previously recorded during the HDSS baseline. Information on household health insurance
      coverage was collected in 2015 as part of routine HDSS updates.

      Standard protocols were used to take anthropometric measurements. Participants were weighed
      with minimal clothing using a digital scale (Seca, Germany) to the nearest 0.1kg and height
      was measured, with participants not wearing shoes, to the nearest 1cm. Body mass index (BMI)
      was calculated as the ratio of weight in kilograms to height in meters squared (kg/m2) and
      categorized according to WHO categories.

      The Global Physical Activity Questionnaire (GPAQ) was used to assess physical activity for
      work, transportation, and leisure. The investigators defined physical inactivity according to
      WHO guidelines. Number of servings of alcoholic beverages consumed was reported over the past
      30 days. The investigators assumed 14 grams of alcohol as a standard drink portion size. A
      household wealth index was created through a principal component analysis of household
      characteristics and assets, and was categorized into quintiles. In the follow-up visit,
      participants were asked about their health over the past year and the reasons for not seeking
      hypertension care.

      A subsample of ~ one fifth of the participants completed a food frequency questionnaire, two
      24-hour dietary recalls, a 24-hour urine collection for sodium, creatinine, protein, and
      potassium, and had capillary total cholesterol and blood glucose measurements taken.
observational model: Cohort
time perspective: Prospective
measure: Systolic blood pressure
time frame: baseline
description: Continuous variable
measure: Visited health professional for hypertension care
time frame: 1-year follow-up
description: Self report of visiting health professional for hypertension care between baseline and follow-up
measure: Taking antihypertensive medication
time frame: 1-year follow-up
description: Self report of taking antihypertensive treatment at time of follow-up
measure: Diastolic blood pressure
time frame: baseline
measure: Hypertension
time frame: baseline
description: SBP >=140 or DBP >=90 or using antihypertensive medication
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Harvard School of Public Health (HSPH)
investigator full name: Goodarz Danaei
investigator title: Associate Professor of Global Health
mesh term: Hypertension