<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/NCT01676623</url>
  </required_header>
  <id_info>
    <org_study_id>IFPRI-S-01 (2)</org_study_id>
    <nct_id>NCT01676623</nct_id>
  </id_info>
  <brief_title>Impact Evaluation of a Social Franchise Model for Improving Infant and Young Child Feeding and Child Nutrition in Vietnam</brief_title>
  <official_title>Impact Evaluation of a Social Franchise Model Implemented by Alive &amp; Thrive for Improving Infant and Young Child Feeding and Child Nutrition in Rural Vietnam</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Food Policy Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FHI 360</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Food Policy Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alive &amp; Thrive is an initiative that aims to improve infant and young child feeding practices&#xD;
      and reduce childhood stunting. In Vietnam, Alive &amp; Thrive's primary intervention is&#xD;
      implemented through a social franchise linked with the government's health system. The impact&#xD;
      evaluation is conducted using a cluster-randomized design in which 20 commune health centers&#xD;
      (CHC) were assigned to the social franchise model, and 20 CHC were assigned to routine&#xD;
      government services. Repeated cross-sectional baseline and endline surveys will be used to&#xD;
      assess the public health impact of this intervention. The baseline was in 2010 and an endline&#xD;
      survey in the same communities will be conducted in 2014. Mixed methods process evaluation&#xD;
      will be conducted in 2011, 2012 and 2013 to study the pathways through which the program&#xD;
      impact is achieved.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Link provided to journal manuscript describing design of evaluation provides additional&#xD;
      detail: http://fnb.sagepub.com/content/34/3_suppl2/S195.full.pdf&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Exclusive breastfeeding among children 0-6 months of age</measure>
    <time_frame>4 years</time_frame>
    <description>Exclusive breastfeeding in children 0-6 months of age is one of the eight WHO-recommended IYCF core indicators will be measured to capture breastfeeding and complementary feeding practices. It is measured using survey based recall by interviewing mothers of children in the age group for the indicator.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child heights and weights (children 24-60 months of age)</measure>
    <time_frame>4 years</time_frame>
    <description>Heights and weights of children in the intervention and comparison communes covered by the CHCs in the study will be assessed in 2014. A new sample of children 24-60 months will be measured in the repeated cross-sectional endline survey to measure these outcomes and compute height-for-age, weight-for-age and weight-for-height z-scores based on the WHO growth reference standards.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complementary feeding for children 6-23.9 months of age</measure>
    <time_frame>4 years</time_frame>
    <description>Indicators of complementary feeding - diet diversity, minimum acceptable diet, and minimum meal frequency, measured in children 6-23.9 months of age are one of the eight WHO-recommended IYCF core indicators will be measured to capture breastfeeding and complementary feeding practices. These are measured using survey based recall by interviewing mothers of children in the age group for the indicator.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early initiation of breastfeeding in children 0-24 months of age</measure>
    <time_frame>4 years</time_frame>
    <description>Early initiation of breastfeeding (in the first hour after birth) is measured in children 0-23.9 months of age and it is one of the eight WHO-recommended IYCF core indicators will be measured to capture breastfeeding and complementary feeding practices. These are measured using survey based recall by interviewing mothers of children in the age group for the indicator. Samples for children 0-6 months and 6-23.9 are combined to calculate this indicator</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4000</enrollment>
  <condition>Child Nutrition</condition>
  <condition>Stunting</condition>
  <condition>Exclusive Breastfeeding</condition>
  <condition>Complementary Feeding</condition>
  <arm_group>
    <arm_group_label>Comparison area, only standard government services</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This intervention arm will receive the standard government services offered at CHCs all over Vietnam. In addition, participants in this arm will be exposed to the nationwide mass media campaign.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A&amp;T Franchise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, the 20 CHCs will offer Alive &amp; Thrive branded franchise services with enhanced quality of IYCF counseling through interpersonal contact between health workers at the commune level and clients who use the commune health services. In addition, the clients could also be exposed to the mass media campaign.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard government health services</intervention_name>
    <description>This intervention will be basic preventive and curative health services provided by the commune health centers. This includes antenatal care, postnatal care and basic nutrition related counseling.</description>
    <arm_group_label>A&amp;T Franchise</arm_group_label>
    <arm_group_label>Comparison area, only standard government services</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Alive &amp; Thrive IYCF franchise services</intervention_name>
    <description>This intervention includes intensive behavioral counseling to improve infant and young child feeding. A package of 15 counseling contacts that are quality assured and branded will be offered to families of infants and young children. Services might also include user fees.</description>
    <arm_group_label>A&amp;T Franchise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mass media campaign</intervention_name>
    <description>Alive &amp; Thrive is implementing a nationwide mass media campaign in 2011, 2012 and 2013, with a focus on improving breastfeeding practices. The mass media intervention includes TV and radio spots as well as an internet site and a telephone hotline.</description>
    <arm_group_label>A&amp;T Franchise</arm_group_label>
    <arm_group_label>Comparison area, only standard government services</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children 0-60 months of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>60 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Purnima Menon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Food Policy Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rahul Rawat, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Food Policy Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Phuong Nguyen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Food Policy Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marie T Ruel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Food Policy Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alive &amp; Thrive &amp; International Food Policy Research Institute</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <link>
    <url>http://www.aliveandthrive.org</url>
    <description>Alive &amp; Thrive's overall web page. Includes description of Vietnam program.</description>
  </link>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>February 29, 2016</last_update_submitted>
  <last_update_submitted_qc>February 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Child nutrition</keyword>
  <keyword>Stunting</keyword>
  <keyword>Exclusive breastfeeding</keyword>
  <keyword>Complementary feeding</keyword>
  <keyword>Social franchise</keyword>
  <keyword>Mass media</keyword>
  <keyword>Counseling</keyword>
  <keyword>Facility-based</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Growth Disorders</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/NCT01676623
org study id: IFPRI-S-01 (2)
nct id: NCT01676623
lead sponsor: 
collaborator: 
has dmc: No
Alive & Thrive is an initiative that aims to improve infant and young child feeding practices
      and reduce childhood stunting. In Vietnam, Alive & Thrive's primary intervention is
      implemented through a social franchise linked with the government's health system. The impact
      evaluation is conducted using a cluster-randomized design in which 20 commune health centers
      (CHC) were assigned to the social franchise model, and 20 CHC were assigned to routine
      government services. Repeated cross-sectional baseline and endline surveys will be used to
      assess the public health impact of this intervention. The baseline was in 2010 and an endline
      survey in the same communities will be conducted in 2014. Mixed methods process evaluation
      will be conducted in 2011, 2012 and 2013 to study the pathways through which the program
      impact is achieved.
Link provided to journal manuscript describing design of evaluation provides additional
      detail: http://fnb.sagepub.com/content/34/3_suppl2/S195.full.pdf
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Exclusive breastfeeding among children 0-6 months of age
time frame: 4 years
description: Exclusive breastfeeding in children 0-6 months of age is one of the eight WHO-recommended IYCF core indicators will be measured to capture breastfeeding and complementary feeding practices. It is measured using survey based recall by interviewing mothers of children in the age group for the indicator.
measure: Child heights and weights (children 24-60 months of age)
time frame: 4 years
description: Heights and weights of children in the intervention and comparison communes covered by the CHCs in the study will be assessed in 2014. A new sample of children 24-60 months will be measured in the repeated cross-sectional endline survey to measure these outcomes and compute height-for-age, weight-for-age and weight-for-height z-scores based on the WHO growth reference standards.
measure: Complementary feeding for children 6-23.9 months of age
time frame: 4 years
description: Indicators of complementary feeding - diet diversity, minimum acceptable diet, and minimum meal frequency, measured in children 6-23.9 months of age are one of the eight WHO-recommended IYCF core indicators will be measured to capture breastfeeding and complementary feeding practices. These are measured using survey based recall by interviewing mothers of children in the age group for the indicator.
measure: Early initiation of breastfeeding in children 0-24 months of age
time frame: 4 years
description: Early initiation of breastfeeding (in the first hour after birth) is measured in children 0-23.9 months of age and it is one of the eight WHO-recommended IYCF core indicators will be measured to capture breastfeeding and complementary feeding practices. These are measured using survey based recall by interviewing mothers of children in the age group for the indicator. Samples for children 0-6 months and 6-23.9 are combined to calculate this indicator
arm group label: Comparison area, only standard government services
arm group type: Active Comparator
description: This intervention arm will receive the standard government services offered at CHCs all over Vietnam. In addition, participants in this arm will be exposed to the nationwide mass media campaign.
arm group label: A&T Franchise
arm group type: Experimental
description: In this arm, the 20 CHCs will offer Alive & Thrive branded franchise services with enhanced quality of IYCF counseling through interpersonal contact between health workers at the commune level and clients who use the commune health services. In addition, the clients could also be exposed to the mass media campaign.
intervention type: Behavioral
intervention name: Standard government health services
description: This intervention will be basic preventive and curative health services provided by the commune health centers. This includes antenatal care, postnatal care and basic nutrition related counseling.
arm group label: A&T Franchise
arm group label: Comparison area, only standard government services
intervention type: Behavioral
intervention name: Alive & Thrive IYCF franchise services
description: This intervention includes intensive behavioral counseling to improve infant and young child feeding. A package of 15 counseling contacts that are quality assured and branded will be offered to families of infants and young children. Services might also include user fees.
arm group label: A&T Franchise
intervention type: Behavioral
intervention name: Mass media campaign
description: Alive & Thrive is implementing a nationwide mass media campaign in 2011, 2012 and 2013, with a focus on improving breastfeeding practices. The mass media intervention includes TV and radio spots as well as an internet site and a telephone hotline.
arm group label: A&T Franchise
arm group label: Comparison area, only standard government services
criteria: 
gender: All
minimum age: N/A
maximum age: 60 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Purnima Menon, PhD
role: Principal Investigator
affiliation: International Food Policy Research Institute
last name: Rahul Rawat, PhD
role: Principal Investigator
affiliation: International Food Policy Research Institute
last name: Phuong Nguyen, PhD
role: Principal Investigator
affiliation: International Food Policy Research Institute
last name: Marie T Ruel, PhD
role: Principal Investigator
affiliation: International Food Policy Research Institute
facility: 
country: Vietnam
url: http://www.aliveandthrive.org
description: Alive & Thrive's overall web page. Includes description of Vietnam program.
responsible party type: Sponsor
mesh term: Growth Disorders