<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/NCT02259166</url>
  </required_header>
  <id_info>
    <org_study_id>EHFP+ TZ</org_study_id>
    <nct_id>NCT02259166</nct_id>
  </id_info>
  <brief_title>Enhanced Homestead Food Production Plus+ Program in the Lake Zone, Tanzania</brief_title>
  <official_title>Impact of the Evaluation of the Enhanced Homestead Food Production Program in Sengerema, and Ukerewe in the Lake Zone,Tanzania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Food Policy Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helen Keller International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Foreign Affairs, Trade and Development, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Medical Research, Tanzania</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>
      The purpose of this study is to assess if the Enhanced Homestead Food Production Plus (EHFP+)&#xD;
      Program implemented by HKI in Mwanza, Tanzania, enhances uptake of Micronutrient Powder (MNP)&#xD;
      supplementation in children, helps maintaining reduced anemia levels among children after a&#xD;
      blanket provision of MNP, and has an impact on child growth, infant and young child feeding&#xD;
      (IYCF) practices, maternal knowledge related to health, nutrition, WASH and malaria&#xD;
      prevention, food security and women's empowerment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since 1988, Helen Keller International's (HKI) flagship Homestead Food Production (HFP)&#xD;
      program in Asia has helped communities establish technically-improved local food production&#xD;
      systems by creating gardens yielding micronutrient-rich fruits and vegetables over expanded&#xD;
      growing seasons, complemented by the improved rearing of poultry and livestock.&#xD;
&#xD;
      In 2010, HKI introduced an enhanced-HFP (E-HFP) model in Burkina Faso and included a&#xD;
      strengthened nutrition education component; the Essential Nutrition Actions (ENA) framework.&#xD;
      This E-HFP program was evaluated by IFPRI and yielded some encouraging results. With regards&#xD;
      to nutritional outcomes, however, the primary finding was that, while the E-HFP program&#xD;
      improved hemoglobin concentration-an indicator of iron status-the evaluation failed to note a&#xD;
      significant impact of the program on improving children's growth. The primary explanation for&#xD;
      the absence of a measurable improvement in children's growth was the lack of complementary&#xD;
      health interventions that aim to specifically reduce children's disease burden, which, along&#xD;
      with the lack of adequate food and care, is an underlying cause of undernutriton (UNICEF&#xD;
      1990).&#xD;
&#xD;
      Building on lessons learned from the Burkina Faso E-HFP program and a 2011 Tanzania HFP&#xD;
      program, a new model, the Enhanced Homestead Food Production Plus (E-HFP+), was developed for&#xD;
      Tanzania to improve the nutritional status of infants and young children. The new model&#xD;
      strengthens the Behavior Change Communication (BCC) on malaria prevention, WASH, and gender&#xD;
      components and enhances links with the health sector. The model will also test two new&#xD;
      concepts:&#xD;
&#xD;
        1. to assess if the E-HFP+ program has the potential to maintain adequate levels of&#xD;
           hemoglobin concentrations by increasing iron-rich food consumption and malaria&#xD;
           prevention good practices.&#xD;
&#xD;
        2. to assess the effectiveness on anemia of using an existing agriculture-based platform to&#xD;
           promote uptake and utilization of MNP.&#xD;
&#xD;
      The model involves both a set of production and nutrition interventions targeted to mothers&#xD;
      and the provision of a curative treatment for moderate to severe anemia (Micronutrient&#xD;
      Powder).&#xD;
&#xD;
      The main objective of the impact evaluation of the E-HFP+ program is therefore to assess&#xD;
      whether the program:&#xD;
&#xD;
        -  Maintains reduced anemia levels among pre-school aged children after a blanket provision&#xD;
           of Micronutrient Powder (MNP)&#xD;
&#xD;
        -  Improves child growth (measured by HAZ and WHZ)&#xD;
&#xD;
        -  Improves infant and young child feeding (IYCF) practices and maternal knowledge on&#xD;
           health and nutrition&#xD;
&#xD;
        -  Is an appropriate delivery platform to enhance uptake and utilization of MNP&#xD;
           supplementation in children&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Anemia (g/dl and %)</measure>
    <time_frame>Measurements will be made for children aged 6 to 11 months at baseline and up to 3 months, 6 months, 12 months and 18 months (at endline), when the children are between the ages of 24 and 30 months</time_frame>
    <description>Change in prevalence of anemia and hemoglobin concentration will be measured over the course of the program period.(at baseline, during follow-up after 3, 6 and 12 months and after 18 months at endline)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Growth (Z-score and %)</measure>
    <time_frame>Measurements will be made for children between the ages of 6 and 11 months of age at baseline and 18 months later, at endline, when the children are between the ages of 24 and 30 months</time_frame>
    <description>Change in height-for-age Z-scores, weight-for-age Z-scores and weight-for-height Z-scores will be measured as well as the change in the prevalence of stunting (HAZ&lt;-2), underweight (WAZ&lt;-2) and wasting (WHZ&lt;-2) over the course of the program period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical markers</measure>
    <time_frame>Baseline (June 2014), Follow-up1 (up to 3 months) and after 18 months at Endline</time_frame>
    <description>Change in plasmatic concentration of iron biomarkers (transferring receptors and ferritin; TfR and F), in concentration of vitamin A biomarkers (retinolbindingprotein; RBP) and inflammatory proteins (C-reactiveprotein and alpha-1 acidglycoprotein; CRP and AGP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary diversity (%)</measure>
    <time_frame>Baseline (2014) and after 18 months at Endline</time_frame>
    <description>Measured with a questionnaire using a qualitative 24h recall. Unit: Number of food group consumed and percentage of children having consumed 4 groups (upon 7) the previous day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food security (%)</measure>
    <time_frame>Baseline (2014) and after 18 months at Endline (2016)</time_frame>
    <description>Measured with a questionnaire to calculate the HFIAS score. Unit: percentage of household</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Women's empowerment (%)</measure>
    <time_frame>Baseline (2014) and after 18 months at Endline (2016)</time_frame>
    <description>Measured by questionnaire, using a decision-making module and a domestic violence module. Percentage of women over a calculated score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal health and nutrition/WASH/malaria-related knowledge (%)</measure>
    <time_frame>Baseline (2014) and after 18 months at Endline (2016)</time_frame>
    <description>Using questionnaire on knowledge. Percentage of women giving adequate answer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IYCF/WASH/malaria practices (%)</measure>
    <time_frame>Baseline (2014) and after 18 months at Endline (2016)</time_frame>
    <description>Using questionnaire on practices. Percentage of women with adequate practices.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2325</enrollment>
  <condition>Anemia</condition>
  <condition>Growth Retardation</condition>
  <arm_group>
    <arm_group_label>EHFP+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group receiving the intervention EHFP+, in addition to MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EHFP+</intervention_name>
    <description>Enhanced-homestead food production program including home gardening and poultry rearing + WASH interventions + SBCC around the essential nutrition actions and WASH/malaria prevention with a gender component.</description>
    <arm_group_label>EHFP+</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women living in the study area&#xD;
&#xD;
          -  having one child aged 6-12 months of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with severe anemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>Erin Smith</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helen Keller International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute for Medical Research</name>
      <address>
        <city>Mwanza</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>September 16, 2016</last_update_submitted>
  <last_update_submitted_qc>September 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT02259166
org study id: EHFP+ TZ
nct id: NCT02259166
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to assess if the Enhanced Homestead Food Production Plus (EHFP+)
      Program implemented by HKI in Mwanza, Tanzania, enhances uptake of Micronutrient Powder (MNP)
      supplementation in children, helps maintaining reduced anemia levels among children after a
      blanket provision of MNP, and has an impact on child growth, infant and young child feeding
      (IYCF) practices, maternal knowledge related to health, nutrition, WASH and malaria
      prevention, food security and women's empowerment.
Since 1988, Helen Keller International's (HKI) flagship Homestead Food Production (HFP)
      program in Asia has helped communities establish technically-improved local food production
      systems by creating gardens yielding micronutrient-rich fruits and vegetables over expanded
      growing seasons, complemented by the improved rearing of poultry and livestock.

      In 2010, HKI introduced an enhanced-HFP (E-HFP) model in Burkina Faso and included a
      strengthened nutrition education component; the Essential Nutrition Actions (ENA) framework.
      This E-HFP program was evaluated by IFPRI and yielded some encouraging results. With regards
      to nutritional outcomes, however, the primary finding was that, while the E-HFP program
      improved hemoglobin concentration-an indicator of iron status-the evaluation failed to note a
      significant impact of the program on improving children's growth. The primary explanation for
      the absence of a measurable improvement in children's growth was the lack of complementary
      health interventions that aim to specifically reduce children's disease burden, which, along
      with the lack of adequate food and care, is an underlying cause of undernutriton (UNICEF
      1990).

      Building on lessons learned from the Burkina Faso E-HFP program and a 2011 Tanzania HFP
      program, a new model, the Enhanced Homestead Food Production Plus (E-HFP+), was developed for
      Tanzania to improve the nutritional status of infants and young children. The new model
      strengthens the Behavior Change Communication (BCC) on malaria prevention, WASH, and gender
      components and enhances links with the health sector. The model will also test two new
      concepts:

        1. to assess if the E-HFP+ program has the potential to maintain adequate levels of
           hemoglobin concentrations by increasing iron-rich food consumption and malaria
           prevention good practices.

        2. to assess the effectiveness on anemia of using an existing agriculture-based platform to
           promote uptake and utilization of MNP.

      The model involves both a set of production and nutrition interventions targeted to mothers
      and the provision of a curative treatment for moderate to severe anemia (Micronutrient
      Powder).

      The main objective of the impact evaluation of the E-HFP+ program is therefore to assess
      whether the program:

        -  Maintains reduced anemia levels among pre-school aged children after a blanket provision
           of Micronutrient Powder (MNP)

        -  Improves child growth (measured by HAZ and WHZ)

        -  Improves infant and young child feeding (IYCF) practices and maternal knowledge on
           health and nutrition

        -  Is an appropriate delivery platform to enhance uptake and utilization of MNP
           supplementation in children
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Anemia (g/dl and %)
time frame: Measurements will be made for children aged 6 to 11 months at baseline and up to 3 months, 6 months, 12 months and 18 months (at endline), when the children are between the ages of 24 and 30 months
description: Change in prevalence of anemia and hemoglobin concentration will be measured over the course of the program period.(at baseline, during follow-up after 3, 6 and 12 months and after 18 months at endline)
measure: Growth (Z-score and %)
time frame: Measurements will be made for children between the ages of 6 and 11 months of age at baseline and 18 months later, at endline, when the children are between the ages of 24 and 30 months
description: Change in height-for-age Z-scores, weight-for-age Z-scores and weight-for-height Z-scores will be measured as well as the change in the prevalence of stunting (HAZ<-2), underweight (WAZ<-2) and wasting (WHZ<-2) over the course of the program period
measure: Biochemical markers
time frame: Baseline (June 2014), Follow-up1 (up to 3 months) and after 18 months at Endline
description: Change in plasmatic concentration of iron biomarkers (transferring receptors and ferritin; TfR and F), in concentration of vitamin A biomarkers (retinolbindingprotein; RBP) and inflammatory proteins (C-reactiveprotein and alpha-1 acidglycoprotein; CRP and AGP)
measure: Dietary diversity (%)
time frame: Baseline (2014) and after 18 months at Endline
description: Measured with a questionnaire using a qualitative 24h recall. Unit: Number of food group consumed and percentage of children having consumed 4 groups (upon 7) the previous day
measure: Food security (%)
time frame: Baseline (2014) and after 18 months at Endline (2016)
description: Measured with a questionnaire to calculate the HFIAS score. Unit: percentage of household
measure: Women's empowerment (%)
time frame: Baseline (2014) and after 18 months at Endline (2016)
description: Measured by questionnaire, using a decision-making module and a domestic violence module. Percentage of women over a calculated score.
measure: Maternal health and nutrition/WASH/malaria-related knowledge (%)
time frame: Baseline (2014) and after 18 months at Endline (2016)
description: Using questionnaire on knowledge. Percentage of women giving adequate answer.
measure: IYCF/WASH/malaria practices (%)
time frame: Baseline (2014) and after 18 months at Endline (2016)
description: Using questionnaire on practices. Percentage of women with adequate practices.
arm group label: EHFP+
arm group type: Experimental
description: Group receiving the intervention EHFP+, in addition to MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months
arm group label: Control
arm group type: No Intervention
description: MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months
intervention type: Other
intervention name: EHFP+
description: Enhanced-homestead food production program including home gardening and poultry rearing + WASH interventions + SBCC around the essential nutrition actions and WASH/malaria prevention with a gender component.
arm group label: EHFP+
criteria: 
gender: All
minimum age: 6 Months
maximum age: 12 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Rahul Rawat, PhD
role: Principal Investigator
affiliation: International Food Policy Research Institute
last name: Erin Smith
role: Principal Investigator
affiliation: Helen Keller International
facility: 
country: Tanzania
responsible party type: Sponsor
sharing ipd: No