<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/NCT03800498</url>
  </required_header>
  <id_info>
    <org_study_id>SIHS</org_study_id>
    <nct_id>NCT03800498</nct_id>
  </id_info>
  <brief_title>Shalamar Institute of Health Sciences</brief_title>
  <official_title>Shalamar Institute of Health Sciences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allama Iqbal Open University Islamabad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allama Iqbal Open University Islamabad</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>
      Effect of Didactic intervention regarding Dietary Approach to Stop Hypertension (DASH) on&#xD;
      Hypertensive Patients Blood Pressure, Knowledge and Attitude at a Tertiary Hospital of Lahore&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To explore the effect of didactic intervention regarding dietary approach to stop&#xD;
      hypertension (DASH) on hypertensive patients blood pressure, knowledge and attitude.&#xD;
&#xD;
      Study Design: Randomized controlled trial Place and Duration of Study: Punjab Institute of&#xD;
      Cardiology (PIC) Lahore. From June 2018 to Oct 2018.&#xD;
&#xD;
      Methodology: Seventy volunteers aged 20-60 years attending regularly outpatient department at&#xD;
      Punjab institute of cardiology Lahore, with systolic &gt; 130 mm hg, diastolic &gt; 80 mm hg were&#xD;
      selected and assigned into 2 groups, i.e. Intervention and control, by simple random lottery&#xD;
      method. For twelve weeks, only intervention group were given DASH education. Both groups were&#xD;
      checked for DASH knowledge, attitude, and systolic diastolic blood pressure, before and after&#xD;
      education session. Pre-tested questionnaire was used for demographic, attitude and knowledge&#xD;
      data collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2018</start_date>
  <completion_date type="Actual">October 10, 2018</completion_date>
  <primary_completion_date type="Actual">September 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pre-tested questionnaire was used</measure>
    <time_frame>1 month</time_frame>
    <description>10 knowledge questions were asked with minimum score 0 and maximum 10. Attitude assessment consisted of 4 questions and score range was 0-4.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Effect of Didactic Intervention Regarding (DASH) on Hypertension</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For twelve weeks, only intervention group were given DASH education</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controlled</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Controlled group not received DASH education</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DASH Education</intervention_name>
    <description>DASH health education about general knowledge of DASH diet Plan and lifestyle modification</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertensive patient aged 20-60 years attending regularly at Punjab institute of&#xD;
             cardiology outpatient department Lahore&#xD;
&#xD;
          -  systolic &gt; 130 mm hg&#xD;
&#xD;
          -  diastolic &gt; 80 mm hg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 20 years age&#xD;
&#xD;
          -  patient diagnosed with secondary hypertension&#xD;
&#xD;
          -  any mental and physical ailment that may interfere the intervention like deafness and&#xD;
             blindness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zaheer Ahmad, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shalamar Institute of Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nazia</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>54000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Allama Iqbal Open University Islamabad</investigator_affiliation>
    <investigator_full_name>Naiza Yousef</investigator_full_name>
    <investigator_title>Student</investigator_title>
  </responsible_party>
  <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/NCT03800498
org study id: SIHS
nct id: NCT03800498
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Effect of Didactic intervention regarding Dietary Approach to Stop Hypertension (DASH) on
      Hypertensive Patients Blood Pressure, Knowledge and Attitude at a Tertiary Hospital of Lahore
Objective: To explore the effect of didactic intervention regarding dietary approach to stop
      hypertension (DASH) on hypertensive patients blood pressure, knowledge and attitude.

      Study Design: Randomized controlled trial Place and Duration of Study: Punjab Institute of
      Cardiology (PIC) Lahore. From June 2018 to Oct 2018.

      Methodology: Seventy volunteers aged 20-60 years attending regularly outpatient department at
      Punjab institute of cardiology Lahore, with systolic > 130 mm hg, diastolic > 80 mm hg were
      selected and assigned into 2 groups, i.e. Intervention and control, by simple random lottery
      method. For twelve weeks, only intervention group were given DASH education. Both groups were
      checked for DASH knowledge, attitude, and systolic diastolic blood pressure, before and after
      education session. Pre-tested questionnaire was used for demographic, attitude and knowledge
      data collection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pre-tested questionnaire was used
time frame: 1 month
description: 10 knowledge questions were asked with minimum score 0 and maximum 10. Attitude assessment consisted of 4 questions and score range was 0-4.
arm group label: Intervention
arm group type: Experimental
description: For twelve weeks, only intervention group were given DASH education
arm group label: Controlled
arm group type: No Intervention
description: Controlled group not received DASH education
intervention type: Other
intervention name: DASH Education
description: DASH health education about general knowledge of DASH diet Plan and lifestyle modification
arm group label: Intervention
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Zaheer Ahmad, PhD
role: Principal Investigator
affiliation: Shalamar Institute of Health Sciences
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Allama Iqbal Open University Islamabad
investigator full name: Naiza Yousef
investigator title: Student
mesh term: Hypertension