<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/NCT02236468</url>
  </required_header>
  <id_info>
    <org_study_id>CHANGE BF</org_study_id>
    <nct_id>NCT02236468</nct_id>
  </id_info>
  <brief_title>Creating Homestead Agriculture for Nutrition and Gender Equity (CHANGE) in Burkina Faso</brief_title>
  <acronym>CHANGE</acronym>
  <official_title>Creating Homestead Agriculture for Nutrition and Gender Equity in Burkina Faso</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>
  </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 the long-term impact of the Enhanced Homestead Food&#xD;
      Production Program implemented by HKI on household food security and nutritional status, as&#xD;
      well as the impact on including additional interventions (BCC on WASH and malaria prevention,&#xD;
      distribution of preventive lipid-based nutrient supplements (LNS)) to children aged 6-24&#xD;
      months old, in addition to the standard E-HFP model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over the past twenty years, Helen Keller International (HKI) has implemented its Homestead&#xD;
      Food Production (HFP) program to increase household production of micronutrient-rich foods&#xD;
      and improve the quality of diets among vulnerable households across Asia and, more recently,&#xD;
      Africa. As part of the program, village model farms -which support diversified, year-round&#xD;
      production of micronutrient-rich crops, and improved breeds of poultry and small animals-are&#xD;
      established to demonstrate gardening and small animal-raising techniques to program&#xD;
      participants. Program participants in turn are established to demonstrate gardening and small&#xD;
      animal-raising techniques to program participants. Program participants in turn are provided&#xD;
      with small inputs such as seeds, seedlings, and small tools to establish home gardens using&#xD;
      techniques they learn at the village model farms. In addition, the program uses a behavior&#xD;
      change communication (BCC) strategy to increase participant's health and nutrition-related&#xD;
      knowledge and practices.&#xD;
&#xD;
      In 2010, HKI introduced an enhanced-HFP (E-HFP) model in the Gourma province of Burkina Faso&#xD;
      with support from the USAID. The project used a randomized cluster design to assess the&#xD;
      impact of HKI's package of interventions on 1,200 beneficiary and 800 control children aged&#xD;
      3-12 months at baseline. Given the encouraging results of IFPRI's first evaluation of that&#xD;
      project, HKI is working to continue to improve and evaluate its E-HFP program in Burkina&#xD;
      Faso. Based on the recommendations from the initial evaluation in Burkina Faso, this research&#xD;
      aims to assess both the long-term impact of the E-HFP program as well as the impact of&#xD;
      including additional interventions, using the E-HFP platform to deliver these interventions.&#xD;
      The primary research questions that will be addresses will be:&#xD;
&#xD;
        -  What is the relative impact of a long-term E-HFP program compared to a short-term E-HFP&#xD;
           program on household food security and child nutritional status?&#xD;
&#xD;
        -  What is the impact of including additional messages and the promotion of practices&#xD;
           related to water, sanitation, hygiene, and malaria prevention (including bednet&#xD;
           utilization) in the BCC strategy, in addition to the standard E-HFP model?&#xD;
&#xD;
        -  What is the impact of distributing preventive lipid-based nutrient supplements (LNS) to&#xD;
           children between the ages of 6-24 months in addition to participation in the E-HFP&#xD;
           program + additional messages and the promotion of practices related to water,&#xD;
           sanitation, hygiene, and malaria prevention (including bednet utilization)?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 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>Hemoglobin (g/dl)</measure>
    <time_frame>Measurements will be made for children between the ages of 0 and 12 months of age at baseline and 2 years later, at endline, when the children are between the ages of 24 and 36 months.</time_frame>
    <description>Changes in hemoglobin (g/dl) and in prevalence of anemia (&lt;11g/dl) will be measured over the course of the two year program period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dietary diversity (%)</measure>
    <time_frame>Baseline (2014) and after 24 months at Endline (2016)</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 24 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>Biochemical markers</measure>
    <time_frame>Baseline (2014) and after 24 months at Endline (2016)</time_frame>
    <description>Change in plasmatic concentration of iron biomarkers (tranferrin receptors and ferritin; TfR in mg/L and F in μg/L), in concentration of vitamine A biomarkers (retinolbindingprotein; RBP in μmol/L) and inflammatory proteins (C-reactiveprotein and alpha-1 acidglycoprotein; CRP in mg/L and AGP in g/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Women's empowerment (%)</measure>
    <time_frame>Baseline (2014) and after 24 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 24 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 24 months at Endline (2016)</time_frame>
    <description>Using questionnaire on practices. Percentage of women with adequate practices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth (Z-score and %)</measure>
    <time_frame>Measurements will be made for children between the ages of 0 and 12 months of age at baseline and 2 years later, at endline, when the children are between the ages of 24 and 36 months.</time_frame>
    <description>Change in heigh-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 (WAS&lt;-2) and wasting (WHZ&lt;-2) over the course of the two year program period.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">2747</enrollment>
  <condition>Anemia</condition>
  <condition>Growth Retardation</condition>
  <arm_group>
    <arm_group_label>new EHFP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group newly participating in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014</description>
  </arm_group>
  <arm_group>
    <arm_group_label>old EHFP+WASH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group participating in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010 + WASH/malaria behavior change communication since 2014</description>
  </arm_group>
  <arm_group>
    <arm_group_label>new EHFP+WASH</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group newly participating in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014 + WASH/malaria behavior change communication since 2014</description>
  </arm_group>
  <arm_group>
    <arm_group_label>old EHFP+WASH+LNS distribution</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group participating in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010 + WASH/malaria behavior change communication and distribution of LNS since 2014</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced-Homestead Food Production Program (old)</intervention_name>
    <description>Participation in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010</description>
    <arm_group_label>old EHFP+WASH</arm_group_label>
    <arm_group_label>old EHFP+WASH+LNS distribution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>WASH/malaria behavior change</intervention_name>
    <description>WASH/malaria behavior change communication</description>
    <arm_group_label>new EHFP+WASH</arm_group_label>
    <arm_group_label>old EHFP+WASH</arm_group_label>
    <arm_group_label>old EHFP+WASH+LNS distribution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>LNS distribution</intervention_name>
    <description>Distribution of Nutributter (Fanga Degue) for children</description>
    <arm_group_label>old EHFP+WASH+LNS distribution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced-Homestead Food Production Program (new)</intervention_name>
    <description>Participation in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014</description>
    <arm_group_label>new EHFP</arm_group_label>
    <arm_group_label>new EHFP+WASH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mother of child between the ages of 0 and 12 months and her child&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deanna Olney, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Food Policy Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hellen Keller International</name>
      <address>
        <city>Fada</city>
        <state>Gourma</state>
        <country>Burkina Faso</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 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>
  <!-- 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/NCT02236468
org study id: CHANGE BF
nct id: NCT02236468
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to assess the long-term impact of the Enhanced Homestead Food
      Production Program implemented by HKI on household food security and nutritional status, as
      well as the impact on including additional interventions (BCC on WASH and malaria prevention,
      distribution of preventive lipid-based nutrient supplements (LNS)) to children aged 6-24
      months old, in addition to the standard E-HFP model.
Over the past twenty years, Helen Keller International (HKI) has implemented its Homestead
      Food Production (HFP) program to increase household production of micronutrient-rich foods
      and improve the quality of diets among vulnerable households across Asia and, more recently,
      Africa. As part of the program, village model farms -which support diversified, year-round
      production of micronutrient-rich crops, and improved breeds of poultry and small animals-are
      established to demonstrate gardening and small animal-raising techniques to program
      participants. Program participants in turn are established to demonstrate gardening and small
      animal-raising techniques to program participants. Program participants in turn are provided
      with small inputs such as seeds, seedlings, and small tools to establish home gardens using
      techniques they learn at the village model farms. In addition, the program uses a behavior
      change communication (BCC) strategy to increase participant's health and nutrition-related
      knowledge and practices.

      In 2010, HKI introduced an enhanced-HFP (E-HFP) model in the Gourma province of Burkina Faso
      with support from the USAID. The project used a randomized cluster design to assess the
      impact of HKI's package of interventions on 1,200 beneficiary and 800 control children aged
      3-12 months at baseline. Given the encouraging results of IFPRI's first evaluation of that
      project, HKI is working to continue to improve and evaluate its E-HFP program in Burkina
      Faso. Based on the recommendations from the initial evaluation in Burkina Faso, this research
      aims to assess both the long-term impact of the E-HFP program as well as the impact of
      including additional interventions, using the E-HFP platform to deliver these interventions.
      The primary research questions that will be addresses will be:

        -  What is the relative impact of a long-term E-HFP program compared to a short-term E-HFP
           program on household food security and child nutritional status?

        -  What is the impact of including additional messages and the promotion of practices
           related to water, sanitation, hygiene, and malaria prevention (including bednet
           utilization) in the BCC strategy, in addition to the standard E-HFP model?

        -  What is the impact of distributing preventive lipid-based nutrient supplements (LNS) to
           children between the ages of 6-24 months in addition to participation in the E-HFP
           program + additional messages and the promotion of practices related to water,
           sanitation, hygiene, and malaria prevention (including bednet utilization)?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Hemoglobin (g/dl)
time frame: Measurements will be made for children between the ages of 0 and 12 months of age at baseline and 2 years later, at endline, when the children are between the ages of 24 and 36 months.
description: Changes in hemoglobin (g/dl) and in prevalence of anemia (<11g/dl) will be measured over the course of the two year program period.
measure: Dietary diversity (%)
time frame: Baseline (2014) and after 24 months at Endline (2016)
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 24 months at Endline (2016)
description: Measured with a questionnaire to calculate the HFIAS score. Unit: percentage of household
measure: Biochemical markers
time frame: Baseline (2014) and after 24 months at Endline (2016)
description: Change in plasmatic concentration of iron biomarkers (tranferrin receptors and ferritin; TfR in mg/L and F in μg/L), in concentration of vitamine A biomarkers (retinolbindingprotein; RBP in μmol/L) and inflammatory proteins (C-reactiveprotein and alpha-1 acidglycoprotein; CRP in mg/L and AGP in g/L).
measure: Women's empowerment (%)
time frame: Baseline (2014) and after 24 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 24 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 24 months at Endline (2016)
description: Using questionnaire on practices. Percentage of women with adequate practices.
measure: Growth (Z-score and %)
time frame: Measurements will be made for children between the ages of 0 and 12 months of age at baseline and 2 years later, at endline, when the children are between the ages of 24 and 36 months.
description: Change in heigh-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 (WAS<-2) and wasting (WHZ<-2) over the course of the two year program period.
arm group label: new EHFP
arm group type: Experimental
description: Group newly participating in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014
arm group label: old EHFP+WASH
arm group type: Experimental
description: Group participating in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010 + WASH/malaria behavior change communication since 2014
arm group label: new EHFP+WASH
arm group type: Other
description: Group newly participating in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014 + WASH/malaria behavior change communication since 2014
arm group label: old EHFP+WASH+LNS distribution
arm group type: Other
description: Group participating in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010 + WASH/malaria behavior change communication and distribution of LNS since 2014
intervention type: Other
intervention name: Enhanced-Homestead Food Production Program (old)
description: Participation in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010
arm group label: old EHFP+WASH
arm group label: old EHFP+WASH+LNS distribution
intervention type: Behavioral
intervention name: WASH/malaria behavior change
description: WASH/malaria behavior change communication
arm group label: new EHFP+WASH
arm group label: old EHFP+WASH
arm group label: old EHFP+WASH+LNS distribution
intervention type: Dietary Supplement
intervention name: LNS distribution
description: Distribution of Nutributter (Fanga Degue) for children
arm group label: old EHFP+WASH+LNS distribution
intervention type: Other
intervention name: Enhanced-Homestead Food Production Program (new)
description: Participation in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014
arm group label: new EHFP
arm group label: new EHFP+WASH
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Deanna Olney, PhD
role: Principal Investigator
affiliation: International Food Policy Research Institute
facility: 
country: Burkina Faso
responsible party type: Sponsor