<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/NCT02249286</url>
  </required_header>
  <id_info>
    <org_study_id>CCC-HFP</org_study_id>
    <nct_id>NCT02249286</nct_id>
  </id_info>
  <brief_title>Integrating Nutrition Education &amp; Household Food Production for Child Nutrition</brief_title>
  <official_title>Child-Centred Counselling and Home-Based Food Production to Improve Dietary Adequacy and Growth of Young Children in Southwest Ethiopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jimma University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nestlé Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Flemish Interuniversity Council (VLIR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jimma University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than&#xD;
      the current nutrition and health education when investment on home-based food production is&#xD;
      used as a platform for nutrition education. This project is proposed to evaluate the efficacy&#xD;
      of a food-based package integrating child-centered nutrition counseling and home-based food&#xD;
      production using a between-group comparative intervention study. The intervention comprises&#xD;
      child-centered nutrition counseling for caretakers and support for 'developed' gardens and&#xD;
      improved backyard poultry production.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Growth faltering among Ethiopian infants and young children is one of the highest in&#xD;
      sub-Saharan Africa. Nutrition education on infant and young child feeding has shown good&#xD;
      potential to improve growth of young children whenever it is accessible, context-based and&#xD;
      integrated with locally available resources. The current nutrition education in Ethiopia,&#xD;
      however, appears to be general and lacks the essential components for success. It is mainly&#xD;
      didactic and lacks a motivational approach that can enhance the self-efficacy of mothers for&#xD;
      behavior change. Another important barrier for nutrition education to become effective is&#xD;
      that rural mothers have limited access to nutrient-dense foods that are recommended to be fed&#xD;
      to young children. Therefore, it is expected that low food access by poor households together&#xD;
      with the less motivational approach used may hamper the effectiveness of the current&#xD;
      nutrition education in the country. In Ethiopia, a child-centered counseling approach is&#xD;
      hypothesized to be more effective than the current nutrition and health education when&#xD;
      investment on home-based food production is used as a platform for nutrition education. This&#xD;
      project is proposed to evaluate the efficacy of a food-based package integrating&#xD;
      child-centered nutrition counseling and home-based food production using a between-group&#xD;
      comparative intervention study. The intervention comprises child-centered nutrition&#xD;
      counseling for caretakers and support for 'developed' gardens and improved backyard poultry&#xD;
      production; whereas the control will only receive the agriculture extension and the existing&#xD;
      health and nutrition education in the area. Two Primary Healthcare Units (one intervention&#xD;
      and one control group) will be selected from Jimma Zone using relevant criteria. A total of&#xD;
      404 (i.e. 202 in each of intervention and control areas) households with infants of age &lt; 12&#xD;
      months will participate in the study for 18 months. The efficacy of the intervention will be&#xD;
      assessed by its effect on child growth and infant and child feeding index as primary&#xD;
      outcomes. Besides the effect on dietary adequacy and growth, the project aims at evaluating&#xD;
      the interactive processes in a longitudinal way to provide evidence on the possible success&#xD;
      factors and barriers encountered. Therefore, secondary outcomes include household production,&#xD;
      income and expenditure in relation to the home-based food production; diet diversity; feeding&#xD;
      and care practices, and morbidity. Data will be compared between intervention and control&#xD;
      groups using linear mixed-effects models and generalized linear models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Child growth [-Prevalence of stunting ][&lt;-2SD]</measure>
    <time_frame>baseline,18 month</time_frame>
    <description>prevalence of stunting will be determined by height for age (Ht/Age) using height /length measured in the recumbent position to the nearest 0.1 cm using a measuring board with an upright wooden base and movable headpiece. as well actual age of child will be taken and expressed in terms of Z score.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">404</enrollment>
  <condition>Behavior</condition>
  <arm_group>
    <arm_group_label>Child Centered Nutrition Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Child Centered Nutrition Counseling</intervention_name>
    <description>The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production; whereas the control will only receive the agriculture extension and the existing health and nutrition education in the area</description>
    <arm_group_label>Child Centered Nutrition Counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>the control will only receive the agriculture extension and the existing health and nutrition education in the area</description>
    <arm_group_label>Child Centered Nutrition Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infants less than 12 month&#xD;
&#xD;
          -  are permanent residents in the area;&#xD;
&#xD;
          -  have no plan to move away during the intervention period;&#xD;
&#xD;
          -  are willing to adopt the agriculture activities; and&#xD;
&#xD;
          -  have adequate place and time to adopt developed gardens &amp; backyard poultry production&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infants with severe acute malnutrition warranting referral to nutrition rehabilitation&#xD;
             program with Ready-To-Use Therapeutic foods&#xD;
&#xD;
          -  severely ill infants with clinical complications warranting hospital referral; and&#xD;
&#xD;
          -  infants with obvious congenital or chronic abnormalities that impair feeding or&#xD;
             physical growth measurements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abebe Gebremariam, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jimma University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alemayehu Argaw, Mr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jimma University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lieven Huybregts, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patrick Kolsteren, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mulusew Gerbaba, Mr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jimma University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Solomon Demeke, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jimma University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joep Grosemans, Mr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Provincial university college Limburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amanuel Tesfay, Mr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jimma University</affiliation>
  </overall_official>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>March 4, 2016</last_update_submitted>
  <last_update_submitted_qc>March 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jimma University</investigator_affiliation>
    <investigator_full_name>Abebe Gebremariam</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Child Centered Counseling</keyword>
  <keyword>Home based food production</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Health</keyword>
  <keyword>IYCF</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/NCT02249286
org study id: CCC-HFP
nct id: NCT02249286
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than
      the current nutrition and health education when investment on home-based food production is
      used as a platform for nutrition education. This project is proposed to evaluate the efficacy
      of a food-based package integrating child-centered nutrition counseling and home-based food
      production using a between-group comparative intervention study. The intervention comprises
      child-centered nutrition counseling for caretakers and support for 'developed' gardens and
      improved backyard poultry production.
Growth faltering among Ethiopian infants and young children is one of the highest in
      sub-Saharan Africa. Nutrition education on infant and young child feeding has shown good
      potential to improve growth of young children whenever it is accessible, context-based and
      integrated with locally available resources. The current nutrition education in Ethiopia,
      however, appears to be general and lacks the essential components for success. It is mainly
      didactic and lacks a motivational approach that can enhance the self-efficacy of mothers for
      behavior change. Another important barrier for nutrition education to become effective is
      that rural mothers have limited access to nutrient-dense foods that are recommended to be fed
      to young children. Therefore, it is expected that low food access by poor households together
      with the less motivational approach used may hamper the effectiveness of the current
      nutrition education in the country. In Ethiopia, a child-centered counseling approach is
      hypothesized to be more effective than the current nutrition and health education when
      investment on home-based food production is used as a platform for nutrition education. This
      project is proposed to evaluate the efficacy of a food-based package integrating
      child-centered nutrition counseling and home-based food production using a between-group
      comparative intervention study. The intervention comprises child-centered nutrition
      counseling for caretakers and support for 'developed' gardens and improved backyard poultry
      production; whereas the control will only receive the agriculture extension and the existing
      health and nutrition education in the area. Two Primary Healthcare Units (one intervention
      and one control group) will be selected from Jimma Zone using relevant criteria. A total of
      404 (i.e. 202 in each of intervention and control areas) households with infants of age < 12
      months will participate in the study for 18 months. The efficacy of the intervention will be
      assessed by its effect on child growth and infant and child feeding index as primary
      outcomes. Besides the effect on dietary adequacy and growth, the project aims at evaluating
      the interactive processes in a longitudinal way to provide evidence on the possible success
      factors and barriers encountered. Therefore, secondary outcomes include household production,
      income and expenditure in relation to the home-based food production; diet diversity; feeding
      and care practices, and morbidity. Data will be compared between intervention and control
      groups using linear mixed-effects models and generalized linear models.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Child growth [-Prevalence of stunting ][<-2SD]
time frame: baseline,18 month
description: prevalence of stunting will be determined by height for age (Ht/Age) using height /length measured in the recumbent position to the nearest 0.1 cm using a measuring board with an upright wooden base and movable headpiece. as well actual age of child will be taken and expressed in terms of Z score.
arm group label: Child Centered Nutrition Counseling
arm group type: Experimental
description: The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production.
arm group label: No intervention
arm group type: No Intervention
intervention type: Behavioral
intervention name: Child Centered Nutrition Counseling
description: The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production; whereas the control will only receive the agriculture extension and the existing health and nutrition education in the area
arm group label: Child Centered Nutrition Counseling
intervention type: Other
intervention name: no intervention
description: the control will only receive the agriculture extension and the existing health and nutrition education in the area
arm group label: Child Centered Nutrition Counseling
criteria: 
gender: All
minimum age: 3 Months
maximum age: 12 Months
healthy volunteers: No
last name: Abebe Gebremariam, Professor
role: Principal Investigator
affiliation: Jimma University
last name: Alemayehu Argaw, Mr
role: Principal Investigator
affiliation: Jimma University
last name: Lieven Huybregts, Dr
role: Principal Investigator
affiliation: University Ghent
last name: Patrick Kolsteren, Professor
role: Principal Investigator
affiliation: University Ghent
last name: Mulusew Gerbaba, Mr.
role: Principal Investigator
affiliation: Jimma University
last name: Solomon Demeke, Professor
role: Principal Investigator
affiliation: Jimma University
last name: Joep Grosemans, Mr.
role: Principal Investigator
affiliation: Provincial university college Limburg
last name: Amanuel Tesfay, Mr.
role: Principal Investigator
affiliation: Jimma University
responsible party type: Principal Investigator
investigator affiliation: Jimma University
investigator full name: Abebe Gebremariam
investigator title: Professor