<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/NCT02975063</url>
  </required_header>
  <id_info>
    <org_study_id>08100206</org_study_id>
    <nct_id>NCT02975063</nct_id>
  </id_info>
  <brief_title>Alive &amp; Thrive Nigeria Impact Evaluation</brief_title>
  <official_title>Alive &amp; Thrive Nigeria Impact Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FHI 360</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>TNS RMS Nigeria, Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RTI International</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>
      Investigators will use a cluster-randomized design to evaluate the overall impact of the&#xD;
      Alive &amp; Thrive infant and young child feeding communication strategies in Lagos and Kaduna&#xD;
      States, Nigeria. The impact in each state and in a subset of urban local government areas&#xD;
      (LGAs) will also be tested.This is a mixed methods evaluation; the quantitative data will be&#xD;
      complemented by qualitative data obtained from different groups targeted by or involved in&#xD;
      the program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adequate nutrition during the first 1,000 days is necessary for children to grow and develop&#xD;
      to their full potential. Alive &amp; Thrive (A&amp;T) contributes to better nutrition during the&#xD;
      first 1,000 days by promoting improved infant and young child feeding (IYCF) practices. A&amp;T&#xD;
      is expanding its efforts to Nigeria and will target Lagos and Kaduna States. In Nigeria, 33%&#xD;
      of infants are breastfed within 1 hour of delivery, 60% are given other fluids in the first 3&#xD;
      days of life, and only 17% of children 0-5.9 months are exclusively breastfed. Approximately&#xD;
      60% of children 6 to 23 months achieve the minimum meal frequency for their age and 19% are&#xD;
      fed four or more food groups per day. To address these gaps in optimal IYCF practices, A&amp;T&#xD;
      will use an implementation framework for IYCF impact at scale that includes advocacy,&#xD;
      interpersonal communication and community mobilization, mass communication, and strategic use&#xD;
      of data. The A&amp;T intervention will be compared to mass media communication on IYCF, which&#xD;
      will be provided throughout the two states. LGAs in Lagos and Kaduna will be randomly&#xD;
      allocated such that two-thirds receive the A&amp;T intervention and one-third are assigned to the&#xD;
      comparison group. The primary objectives of the evaluation are to measure the impact of the&#xD;
      A&amp;T intervention on IYCF practices among mothers with children 0-23 months of age overall, in&#xD;
      each state, and in a subset of urban LGAs. Secondary evaluation objectives are to document:&#xD;
      the type, quantity, and timing of the implementation of A&amp;T program activities; coverage&#xD;
      levels A&amp;T achieves with different program activities; extent to which A&amp;T increases&#xD;
      knowledge and awareness of optimal IYCF practices among women with children 0 to 23 months&#xD;
      and health providers; extent to which A&amp;T improves the capacity of health providers to&#xD;
      counsel mothers on IYCF; and extent to which A&amp;T improves the capacity of stakeholders to&#xD;
      implement community-based activities that support optimal IYCF practices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Actual">December 2, 2020</completion_date>
  <primary_completion_date type="Actual">December 2, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exclusive breastfeeding on the day preceding the interview.</measure>
    <time_frame>2 years</time_frame>
    <description>The proportion of infants 0-5 months who were exclusively breastfed on the previous day.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exclusive breastfeeding from 0-5 months.</measure>
    <time_frame>2 years</time_frame>
    <description>The proportion of children who were exclusively breastfed from 0-5 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding within 1 hour of birth.</measure>
    <time_frame>2 years</time_frame>
    <description>The proportion of children 0-23 months who were breastfed within 1 hour of birth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum dietary diversity.</measure>
    <time_frame>2 years</time_frame>
    <description>The proportion of children 6-23 months who were fed the minimum number of food groups on the previous day based on the WHO infant and young child feeding guidelines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum meal frequency.</measure>
    <time_frame>2 years</time_frame>
    <description>Description: The proportion of children 6-23 months who were fed the minimum number of meals on the previous day based on the World Health Organization infant and young child feeding guidelines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' accurate knowledge of optimal infant and young child feeding practices.</measure>
    <time_frame>2 years</time_frame>
    <description>Mothers' accurate knowledge of:&#xD;
Optimal timing of breastfeeding initiation&#xD;
Optimal duration of exclusive breastfeeding&#xD;
Solution to common breastfeeding problems&#xD;
Optimal timing to introduce complementary foods&#xD;
Optimal dietary diversity and frequency of complementary feeding from 6-23 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health providers' knowledge of optimal infant and young child feeding practices.</measure>
    <time_frame>2 years</time_frame>
    <description>Providers' accurate knowledge of:&#xD;
Optimal timing of breastfeeding initiation&#xD;
Optimal duration of exclusive breastfeeding&#xD;
Solution to common breastfeeding problems&#xD;
Optimal timing to introduce complementary foods&#xD;
Optimal dietary diversity and frequency of complementary feeding from 6-23 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15169</enrollment>
  <condition>Complementary Feeding</condition>
  <arm_group>
    <arm_group_label>A&amp;T IYCF intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A&amp;T IYCF intervention is includes comprehensive IYCF counseling which includes intensive activity that aims to deliver one-on-one counseling at home or in a health facility.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A&amp;T IYCF intervention</intervention_name>
    <description>(1) Interpersonal communication through frontline workers/volunteers to increase mothers' knowledge and practice of optimal infant and young child feeding (IYCF) behaviors. Interpersonal communication will involve multiple contacts with mothers and an array of IYCF messages; (2) Community mobilization activities to raise awareness of the benefits of optimal IYCF practices among opinion leaders and family members, and increase their support to mother for IYCF; (3) Training of facility and community-based health workers on IYCF to improve their ability to support mothers and provide timely information on IYCF; and (4) Mass media communication on IYCF.</description>
    <arm_group_label>A&amp;T IYCF intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For mother's survey:&#xD;
&#xD;
          -  Women of reproductive age (15-49 years),&#xD;
&#xD;
          -  Must be married if 15-17 years,&#xD;
&#xD;
          -  Has a child 0-23 months&#xD;
&#xD;
          -  For provider's survey:&#xD;
&#xD;
          -  Male or female,&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Works in a government or private health facility or works as a community pharmacist,&#xD;
             private patent medicine vendor, or traditional birth attendant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valerie Flax</last_name>
    <role>Principal Investigator</role>
    <affiliation>RTI International</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mariam Fagbemi</last_name>
    <role>Principal Investigator</role>
    <affiliation>TNS RMS Nigeria, Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kantar TNS RMS</name>
      <address>
        <city>Ikeja</city>
        <state>Lagos</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantar TNS RMS</name>
      <address>
        <city>Kaduna</city>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>October 19, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exclusive breastfeeding</keyword>
  <!-- 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/NCT02975063
org study id: 08100206
nct id: NCT02975063
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators will use a cluster-randomized design to evaluate the overall impact of the
      Alive & Thrive infant and young child feeding communication strategies in Lagos and Kaduna
      States, Nigeria. The impact in each state and in a subset of urban local government areas
      (LGAs) will also be tested.This is a mixed methods evaluation; the quantitative data will be
      complemented by qualitative data obtained from different groups targeted by or involved in
      the program.
Adequate nutrition during the first 1,000 days is necessary for children to grow and develop
      to their full potential. Alive & Thrive (A&T) contributes to better nutrition during the
      first 1,000 days by promoting improved infant and young child feeding (IYCF) practices. A&T
      is expanding its efforts to Nigeria and will target Lagos and Kaduna States. In Nigeria, 33%
      of infants are breastfed within 1 hour of delivery, 60% are given other fluids in the first 3
      days of life, and only 17% of children 0-5.9 months are exclusively breastfed. Approximately
      60% of children 6 to 23 months achieve the minimum meal frequency for their age and 19% are
      fed four or more food groups per day. To address these gaps in optimal IYCF practices, A&T
      will use an implementation framework for IYCF impact at scale that includes advocacy,
      interpersonal communication and community mobilization, mass communication, and strategic use
      of data. The A&T intervention will be compared to mass media communication on IYCF, which
      will be provided throughout the two states. LGAs in Lagos and Kaduna will be randomly
      allocated such that two-thirds receive the A&T intervention and one-third are assigned to the
      comparison group. The primary objectives of the evaluation are to measure the impact of the
      A&T intervention on IYCF practices among mothers with children 0-23 months of age overall, in
      each state, and in a subset of urban LGAs. Secondary evaluation objectives are to document:
      the type, quantity, and timing of the implementation of A&T program activities; coverage
      levels A&T achieves with different program activities; extent to which A&T increases
      knowledge and awareness of optimal IYCF practices among women with children 0 to 23 months
      and health providers; extent to which A&T improves the capacity of health providers to
      counsel mothers on IYCF; and extent to which A&T improves the capacity of stakeholders to
      implement community-based activities that support optimal IYCF practices.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Exclusive breastfeeding on the day preceding the interview.
time frame: 2 years
description: The proportion of infants 0-5 months who were exclusively breastfed on the previous day.
measure: Exclusive breastfeeding from 0-5 months.
time frame: 2 years
description: The proportion of children who were exclusively breastfed from 0-5 months.
measure: Breastfeeding within 1 hour of birth.
time frame: 2 years
description: The proportion of children 0-23 months who were breastfed within 1 hour of birth.
measure: Minimum dietary diversity.
time frame: 2 years
description: The proportion of children 6-23 months who were fed the minimum number of food groups on the previous day based on the WHO infant and young child feeding guidelines.
measure: Minimum meal frequency.
time frame: 2 years
description: Description: The proportion of children 6-23 months who were fed the minimum number of meals on the previous day based on the World Health Organization infant and young child feeding guidelines.
measure: Mothers' accurate knowledge of optimal infant and young child feeding practices.
time frame: 2 years
description: Mothers' accurate knowledge of:
Optimal timing of breastfeeding initiation
Optimal duration of exclusive breastfeeding
Solution to common breastfeeding problems
Optimal timing to introduce complementary foods
Optimal dietary diversity and frequency of complementary feeding from 6-23 months
measure: Health providers' knowledge of optimal infant and young child feeding practices.
time frame: 2 years
description: Providers' accurate knowledge of:
Optimal timing of breastfeeding initiation
Optimal duration of exclusive breastfeeding
Solution to common breastfeeding problems
Optimal timing to introduce complementary foods
Optimal dietary diversity and frequency of complementary feeding from 6-23 months
arm group label: A&T IYCF intervention
arm group type: Experimental
description: A&T IYCF intervention is includes comprehensive IYCF counseling which includes intensive activity that aims to deliver one-on-one counseling at home or in a health facility.
arm group label: Control
arm group type: No Intervention
description: No intervention.
intervention type: Behavioral
intervention name: A&T IYCF intervention
description: (1) Interpersonal communication through frontline workers/volunteers to increase mothers' knowledge and practice of optimal infant and young child feeding (IYCF) behaviors. Interpersonal communication will involve multiple contacts with mothers and an array of IYCF messages; (2) Community mobilization activities to raise awareness of the benefits of optimal IYCF practices among opinion leaders and family members, and increase their support to mother for IYCF; (3) Training of facility and community-based health workers on IYCF to improve their ability to support mothers and provide timely information on IYCF; and (4) Mass media communication on IYCF.
arm group label: A&T IYCF intervention
criteria: 
gender: All
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Valerie Flax
role: Principal Investigator
affiliation: RTI International
last name: Mariam Fagbemi
role: Principal Investigator
affiliation: TNS RMS Nigeria, Ltd.
facility: 
facility: 
country: Nigeria
responsible party type: Sponsor