<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/NCT03841123</url>
  </required_header>
  <id_info>
    <org_study_id>UFCSPA-RS</org_study_id>
    <nct_id>NCT03841123</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Dietary Counseling to Prevent Early Consumption of Added Sugar and Ultra-processed Foods</brief_title>
  <official_title>Effectiveness of a Dietary Counseling to Prevent Added Sugar and Ultra-processed Foods During the First Year of Life: a Randomized Field Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Health Science of Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Brazil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Federal University of Bahia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Federal University of Amazonas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of Health Science of Porto Alegre</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 purpose of the study is to prevent the early introduction of added sugar and&#xD;
      ultra-processed foods and evaluate the impact on breastfeeding duration, complementary&#xD;
      feeding quality, growth and prevalence of caries during the first year of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized field trial will be performed at the maternity wards of Friendly Hospitals&#xD;
      Initiative in three regions of Brazil: North, Northeast and South. After delivery, mothers&#xD;
      who accepted to participate in the study will be randomized into control and intervention&#xD;
      groups.It will be performed a weekly block randomization to prevent the contamination of&#xD;
      information among mothers of different groups in the same facility. The intervention mothers&#xD;
      will be advised not to give added sugar and ultra-processed foods during the first year of&#xD;
      life, including a leaflet with colored images as a reminder for mothers. The control group&#xD;
      mothers will not receive the study intervention but will be have all the routine health&#xD;
      assistance of the maternity. At 6 months and 12 months, mothers of both groups will be&#xD;
      visited in their homes and dietary evaluation and anthropometric measurements of their babies&#xD;
      will be assessed. At 12 months of age the infants will have dental examinations and&#xD;
      hemoglobin concentration through a capillary blood test.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2018</start_date>
  <completion_date type="Actual">February 25, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of Added Sugar and ultra-processed foods consumed at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Information will be obtained through two not consecutive dietary 24 hour recall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of Added Sugar and ultra-processed foods consumed at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Information will be obtained through two not consecutive dietary 24 hour recall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight gain pattern at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Weight at birth and six months will be obtained and the weight gain velocity will be calculated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight gain pattern at 12 months</measure>
    <time_frame>12 months.</time_frame>
    <description>Weight at six months and 12 months will be obtained and the weight gain velocity will be calculated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with dental caries</measure>
    <time_frame>12 months</time_frame>
    <description>The dental examination will be performed by dentists</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anemia prevalence</measure>
    <time_frame>12 months</time_frame>
    <description>The hemoglobin levels will be obtained by capillary blood tests</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exclusive breastfeeding duration</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of infants from 0-6 months at age who are fed exclusively with breastfeeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of continued breastfeeding at 1 year</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of children 12 months of age who are breastfed</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">516</enrollment>
  <condition>Infant Nutrition Disorders</condition>
  <condition>Feeding Patterns</condition>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At the maternity wards mothers will receive dietary counseling and leaflets as a reminder to prevent the early introduction of added sugar and ultra-processed foods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>At the maternity wards mothers assigned to control groups will have all the health assistance related to the maternity routine without any interference from the study protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary Counseling</intervention_name>
    <description>The intervention will consist of an individualized, face-to-face, 20 to 30 minute counseling session to mothers by trained health workers who will address healthy eating practices during the first two years of life. A printed, colorful and illustrated material will be used to assist mothers in appropriate food choices, mainly to avoid the introduction of sugar and ultra-processed foods. In addition, they will receive a booklet which addresses the &quot;Ten Steps of Healthy Feeding for children from Birth to Two years of life&quot;. The research team will focus on Step2: &quot;Do not give added sugar or foods with added sugar&quot;, and Step8:&quot;Do not offer ultra-processed foods as candies and soft drinks&quot;. To reinforce the intervention, mothers will receive telephone calls up to the infant reach six months.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newborns with gestational age ≥ 37 weeks&#xD;
&#xD;
          -  single birth&#xD;
&#xD;
          -  Mother with at least 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mothers with HIV or HTLV1 positive&#xD;
&#xD;
          -  Infants with clinical occurrences or other conditions that prohibit breastfeeding or&#xD;
             requires specific dietary treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Hour</minimum_age>
    <maximum_age>72 Hours</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcia R Vitolo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Health Science of Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Health Science of Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Centro Histórico</state>
        <zip>90050-170</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>August 18, 2021</last_update_submitted>
  <last_update_submitted_qc>August 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Health Science of Porto Alegre</investigator_affiliation>
    <investigator_full_name>Marcia Regina Vitolo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>complementary feeding</keyword>
  <keyword>added sugar</keyword>
  <keyword>ultra-processed foods</keyword>
  <keyword>intervention</keyword>
  <keyword>infants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nutrition Disorders</mesh_term>
    <mesh_term>Infant Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Under Discussion</ipd_description>
  </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/NCT03841123
org study id: UFCSPA-RS
nct id: NCT03841123
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to prevent the early introduction of added sugar and
      ultra-processed foods and evaluate the impact on breastfeeding duration, complementary
      feeding quality, growth and prevalence of caries during the first year of life.
This randomized field trial will be performed at the maternity wards of Friendly Hospitals
      Initiative in three regions of Brazil: North, Northeast and South. After delivery, mothers
      who accepted to participate in the study will be randomized into control and intervention
      groups.It will be performed a weekly block randomization to prevent the contamination of
      information among mothers of different groups in the same facility. The intervention mothers
      will be advised not to give added sugar and ultra-processed foods during the first year of
      life, including a leaflet with colored images as a reminder for mothers. The control group
      mothers will not receive the study intervention but will be have all the routine health
      assistance of the maternity. At 6 months and 12 months, mothers of both groups will be
      visited in their homes and dietary evaluation and anthropometric measurements of their babies
      will be assessed. At 12 months of age the infants will have dental examinations and
      hemoglobin concentration through a capillary blood test.

      .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Amount of Added Sugar and ultra-processed foods consumed at 6 months
time frame: 6 months
description: Information will be obtained through two not consecutive dietary 24 hour recall
measure: Amount of Added Sugar and ultra-processed foods consumed at 12 months
time frame: 12 months
description: Information will be obtained through two not consecutive dietary 24 hour recall
measure: weight gain pattern at 6 months
time frame: 6 months
description: Weight at birth and six months will be obtained and the weight gain velocity will be calculated
measure: weight gain pattern at 12 months
time frame: 12 months.
description: Weight at six months and 12 months will be obtained and the weight gain velocity will be calculated
measure: Number of Participants with dental caries
time frame: 12 months
description: The dental examination will be performed by dentists
measure: Anemia prevalence
time frame: 12 months
description: The hemoglobin levels will be obtained by capillary blood tests
measure: Exclusive breastfeeding duration
time frame: 6 months
description: Proportion of infants from 0-6 months at age who are fed exclusively with breastfeeding
measure: Prevalence of continued breastfeeding at 1 year
time frame: 12 months
description: Proportion of children 12 months of age who are breastfed
arm group label: Intervention
arm group type: Experimental
description: At the maternity wards mothers will receive dietary counseling and leaflets as a reminder to prevent the early introduction of added sugar and ultra-processed foods.
arm group label: Control
arm group type: No Intervention
description: At the maternity wards mothers assigned to control groups will have all the health assistance related to the maternity routine without any interference from the study protocol.
intervention type: Other
intervention name: Dietary Counseling
description: The intervention will consist of an individualized, face-to-face, 20 to 30 minute counseling session to mothers by trained health workers who will address healthy eating practices during the first two years of life. A printed, colorful and illustrated material will be used to assist mothers in appropriate food choices, mainly to avoid the introduction of sugar and ultra-processed foods. In addition, they will receive a booklet which addresses the "Ten Steps of Healthy Feeding for children from Birth to Two years of life". The research team will focus on Step2: "Do not give added sugar or foods with added sugar", and Step8:"Do not offer ultra-processed foods as candies and soft drinks". To reinforce the intervention, mothers will receive telephone calls up to the infant reach six months.
arm group label: Intervention
criteria: 
gender: All
minimum age: 1 Hour
maximum age: 72 Hours
healthy volunteers: Accepts Healthy Volunteers
last name: Marcia R Vitolo, PhD
role: Principal Investigator
affiliation: Federal University of Health Science of Porto Alegre
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Health Science of Porto Alegre
investigator full name: Marcia Regina Vitolo
investigator title: Professor
mesh term: Nutrition Disorders
mesh term: Infant Nutrition Disorders
sharing ipd: Undecided
ipd description: Under Discussion