<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/NCT03830021</url>
  </required_header>
  <id_info>
    <org_study_id>ReEducSal001</org_study_id>
    <nct_id>NCT03830021</nct_id>
  </id_info>
  <brief_title>Effect of a Multi-component Education Program on Salt Reduction in Adults</brief_title>
  <official_title>Effect of a Multi-component Education Program on Salt Reduction in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academia Cuf Descobertas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CUF Academic and Research Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>José de Mello Saúde</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pingo Doce</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NOVA Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Academia Cuf Descobertas</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>
      Excess salt intake is a major contributor to high blood pressure, the leading individual risk&#xD;
      factor for cardiovascular events, such as stroke, myocardial infarction and heart failure.&#xD;
      According to PHYSA study, salt intake in Portugal remains much higher (10.7 g) than&#xD;
      recommended by the international health organisations, indicating the need for effective&#xD;
      implementation of salt reduction interventions. In Portugal the main source of daily salt&#xD;
      intake is added salt during cooking, and salt content in bread, cheese and processed meat.&#xD;
&#xD;
      The objective of this study is to determine the effectiveness of a dietary education program&#xD;
      tailored for salt reduction. To assess the effectiveness of the salt reduction program the&#xD;
      investigator's will measure changes in salt consumption levels, by evaluating the 24 h&#xD;
      urinary sodium excretion.&#xD;
&#xD;
      This study is a consortium-initiated, randomised, simple-blinded, controlled trial designed&#xD;
      to assess the effectiveness of a salt reduction program versus generic healthy lifestyle&#xD;
      program in the Lisbon Metropolitan Area.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">September 6, 2019</completion_date>
  <primary_completion_date type="Actual">September 6, 2019</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 24-hour urinary sodium excretion</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference between the intervention and control group in the change in 24-hour urinary sodium excretion from baseline to the end of follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in systolic and diastolic blood pressure</measure>
    <time_frame>12 week</time_frame>
    <description>Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>12 week</time_frame>
    <description>Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>12 week</time_frame>
    <description>Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in salt content in foods purchased</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference between the intervention and control group in the change of salt content in foods purchased from baseline to the end of follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">311</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Salt reduction program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Salt reduction program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy lifestyle program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy lifestyle program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Salt reduction program</intervention_name>
    <description>Dietary and behavioural change program, led by nutritionists, including low sodium dietary advice; use of aromatic herbs and spices in food instead of salt; motivational activities; food diaries; restrict salty processed foods; eat more fresh foods and seasoning advice; problem solving exercises; digital bulletins; individual counselling reinforced at each clinic visit and shopping counselling at local supermarket.</description>
    <arm_group_label>Salt reduction program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy lifestyle program</intervention_name>
    <description>Participants receive an educational healthy lifestyle program that includes 1) methods to cook healthier and the Mediterranean diet based on a high intake of fresh fruit and, vegetables, beans, grain legumes, lentils, nuts, cereals, and olive oil as source of fat; moderate intake of fish, poultry, yoghurt and cheese, low intake of salt, red meat, processed meats and sugar; 2) physical activity; 3) drink more water and reducing alcohol consumption; and 4) sleep education.</description>
    <arm_group_label>Healthy lifestyle program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults between the ages of 20 and 70.&#xD;
&#xD;
          -  Subjects with or without hypertension, not medicated or medicated with medication and&#xD;
             diet stabilized for at least 3 weeks.&#xD;
&#xD;
          -  Responsible for the purchase and confection of their meals.&#xD;
&#xD;
          -  Available to comply with study protocol and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant, breastfeeding or planning to become pregnant within the study period.&#xD;
&#xD;
          -  Subjects with current or previous cardiovascular disease (ischemic cardiovascular&#xD;
             disease, angina stable or unstable; myocardial infarction, stroke or symptomatic&#xD;
             peripheral arteriosclerosis).&#xD;
&#xD;
          -  Subjects with liver or kidney diseases or cancer.&#xD;
&#xD;
          -  Subjects with history of drug, alcohol or other substances abuse, or other factors&#xD;
             limiting their ability to cooperate during the study.&#xD;
&#xD;
          -  Subjects with special dietary needs.&#xD;
&#xD;
          -  Health condition that prevents compliance with study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorge Polónia, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CINTESIS, Faculty of Medicine of the University of Porto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Conceição Calhau, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NOVA Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital CUF Infante Santo</name>
      <address>
        <city>Lisbon</city>
        <zip>1350-070</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital CUF Descobertas</name>
      <address>
        <city>Lisbon</city>
        <zip>1998-018</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <reference>
    <citation>Polonia J, Martins L, Pinto F, Nazare J. Prevalence, awareness, treatment and control of hypertension and salt intake in Portugal: changes over a decade. The PHYSA study. J Hypertens. 2014 Jun;32(6):1211-21. doi: 10.1097/HJH.0000000000000162.</citation>
    <PMID>24675681</PMID>
  </reference>
  <reference>
    <citation>Polonia J, Monteiro J, Almeida J, Silva JA, Bertoquini S. High salt intake is associated with a higher risk of cardiovascular events: a 7.2-year evaluation of a cohort of hypertensive patients. Blood Press Monit. 2016 Oct;21(5):301-6. doi: 10.1097/MBP.0000000000000205.</citation>
    <PMID>27495189</PMID>
  </reference>
  <reference>
    <citation>Polonia J, Lobo MF, Martins L, Pinto F, Nazare J. Estimation of populational 24-h urinary sodium and potassium excretion from spot urine samples: evaluation of four formulas in a large national representative population. J Hypertens. 2017 Mar;35(3):477-486. doi: 10.1097/HJH.0000000000001180.</citation>
    <PMID>27898506</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>January 9, 2020</last_update_submitted>
  <last_update_submitted_qc>January 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03830021
org study id: ReEducSal001
nct id: NCT03830021
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Excess salt intake is a major contributor to high blood pressure, the leading individual risk
      factor for cardiovascular events, such as stroke, myocardial infarction and heart failure.
      According to PHYSA study, salt intake in Portugal remains much higher (10.7 g) than
      recommended by the international health organisations, indicating the need for effective
      implementation of salt reduction interventions. In Portugal the main source of daily salt
      intake is added salt during cooking, and salt content in bread, cheese and processed meat.

      The objective of this study is to determine the effectiveness of a dietary education program
      tailored for salt reduction. To assess the effectiveness of the salt reduction program the
      investigator's will measure changes in salt consumption levels, by evaluating the 24 h
      urinary sodium excretion.

      This study is a consortium-initiated, randomised, simple-blinded, controlled trial designed
      to assess the effectiveness of a salt reduction program versus generic healthy lifestyle
      program in the Lisbon Metropolitan Area.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Change in 24-hour urinary sodium excretion
time frame: 12 weeks
description: Difference between the intervention and control group in the change in 24-hour urinary sodium excretion from baseline to the end of follow-up.
measure: Change in systolic and diastolic blood pressure
time frame: 12 week
description: Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up.
measure: Change in weight
time frame: 12 week
description: Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.
measure: Change in waist circumference
time frame: 12 week
description: Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up.
measure: Change in salt content in foods purchased
time frame: 12 weeks
description: Difference between the intervention and control group in the change of salt content in foods purchased from baseline to the end of follow-up.
arm group label: Salt reduction program
arm group type: Experimental
description: Salt reduction program.
arm group label: Healthy lifestyle program
arm group type: Active Comparator
description: Healthy lifestyle program.
intervention type: Behavioral
intervention name: Salt reduction program
description: Dietary and behavioural change program, led by nutritionists, including low sodium dietary advice; use of aromatic herbs and spices in food instead of salt; motivational activities; food diaries; restrict salty processed foods; eat more fresh foods and seasoning advice; problem solving exercises; digital bulletins; individual counselling reinforced at each clinic visit and shopping counselling at local supermarket.
arm group label: Salt reduction program
intervention type: Behavioral
intervention name: Healthy lifestyle program
description: Participants receive an educational healthy lifestyle program that includes 1) methods to cook healthier and the Mediterranean diet based on a high intake of fresh fruit and, vegetables, beans, grain legumes, lentils, nuts, cereals, and olive oil as source of fat; moderate intake of fish, poultry, yoghurt and cheese, low intake of salt, red meat, processed meats and sugar; 2) physical activity; 3) drink more water and reducing alcohol consumption; and 4) sleep education.
arm group label: Healthy lifestyle program
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jorge Polónia, PhD
role: Principal Investigator
affiliation: CINTESIS, Faculty of Medicine of the University of Porto
last name: Conceição Calhau, PhD
role: Principal Investigator
affiliation: NOVA Medical School
facility: 
facility: 
country: Portugal
citation: Polonia J, Martins L, Pinto F, Nazare J. Prevalence, awareness, treatment and control of hypertension and salt intake in Portugal: changes over a decade. The PHYSA study. J Hypertens. 2014 Jun;32(6):1211-21. doi: 10.1097/HJH.0000000000000162.
PMID: 24675681
citation: Polonia J, Monteiro J, Almeida J, Silva JA, Bertoquini S. High salt intake is associated with a higher risk of cardiovascular events: a 7.2-year evaluation of a cohort of hypertensive patients. Blood Press Monit. 2016 Oct;21(5):301-6. doi: 10.1097/MBP.0000000000000205.
PMID: 27495189
citation: Polonia J, Lobo MF, Martins L, Pinto F, Nazare J. Estimation of populational 24-h urinary sodium and potassium excretion from spot urine samples: evaluation of four formulas in a large national representative population. J Hypertens. 2017 Mar;35(3):477-486. doi: 10.1097/HJH.0000000000001180.
PMID: 27898506
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: Undecided