xml: <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/NCT05971888</url>
    </required_header>
    <id_info>
      <org_study_id>424603</org_study_id>
      <nct_id>NCT05971888</nct_id>
    </id_info>
    <brief_title>Better Dairy For All Evaluation in Ethiopia</brief_title>
    <official_title>Impact and Process Evaluation of the Better Dairy for All Program in Ethiopia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RTI International</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bahir Dar University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Frontieri Consult</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>
        Global Alliance for Improved Nutrition (GAIN)'s &quot;Better Dairy for All&quot; program in Ethiopia&#xD;
        seeks to improve children's and workers' consumption of healthy foods by improving access,&#xD;
        increasing demand, and improving the enabling environment for dairy products by operating at&#xD;
        multiple levels - individuals, households, markets, producers, and policies. RTI and local&#xD;
        partners propose to conduct impact and process evaluations of GAIN's program tailored to the&#xD;
        theory of change. The evaluation will include a mix of quantitative and qualitative methods&#xD;
        and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and&#xD;
        maintenance) evaluation framework.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Dairy products are excellent sources of calcium, vitamin A, and vitamin B12, and&#xD;
        good sources of zinc, but are not widely consumed in Ethiopia. GAIN's Better Dairy for All&#xD;
        program has two main components. One component is focused on increasing dairy consumption&#xD;
        among children 6 months up to 7 years in bottom of the pyramid (BoP) households in Amhara&#xD;
        Region through a demand generation campaign and support to milk houses, cooperatives, and&#xD;
        processors. The other component is focused on increasing consumption of dairy and other&#xD;
        nutritious foods by BoP workers in industries and large-scale farms by making dairy and other&#xD;
        nutritious foods, such as fortified oil and fortified wheat flour and fruits/vegetables,&#xD;
        available at their workplaces accompanied by demand generation activities.&#xD;
  &#xD;
        Objective: The objective of this study is to conduct an impact and process evaluation of&#xD;
        GAIN's Better Dairy for All program.&#xD;
  &#xD;
        Methods: In Amhara, the evaluation will use a parallel group mixed-methods quasi-experimental&#xD;
        before-after design to assess the effectiveness of the intervention on dairy consumption of&#xD;
        children. The evaluation will be carried out in 64 enumeration areas (EAs) in intervention&#xD;
        woredas matched on demographic characteristics with 64 EAs in control woredas. Data will be&#xD;
        collected through household surveys, semi-structured interviews with dairy value chain&#xD;
        actors, and focus group discussions (FGDs) with caregivers of young children. Cross-sectional&#xD;
        population-based household surveys with caregivers of young children will be conducted at&#xD;
        baseline (N=1,144) and endline (N=1,144) to assess intervention impact on dairy consumption&#xD;
        frequency and quantity using difference-in-differences analysis. In the intervention woredas,&#xD;
        evaluators will conduct semi-structured interviews to evaluate program outcomes with milk&#xD;
        houses, milk processors, and cooperatives (N=30) at baseline, midline, and endline.&#xD;
        Evaluators will also conduct FGDs with caregivers of young children (N=8 FGDs) at midline and&#xD;
        endline in the intervention woredas. This data will be used for the process evaluation.&#xD;
  &#xD;
        In industries and large-scale farms, the evaluation of GAIN's program will use a&#xD;
        cross-sectional pre-post design. The evaluation will be carried out in 5 purposefully&#xD;
        selected industries/farms that start the intervention around the same time. Data will be&#xD;
        collected through worker surveys, in-depth interviews (IDIs), and FGDs. Surveys with workers&#xD;
        (N=524) will be conducted before and after the intervention to measure impacts of the program&#xD;
        on workers' dairy consumption frequency and quantity. IDIs with industry/farm owners or&#xD;
        managers and suppliers of dairy and other nutritious foods (N=5-10) and IDIs with workers&#xD;
        (N=15) will be conducted at midline and endline. This data will be used for process&#xD;
        evaluation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 12, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2026</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>
      <intervention_model_description>Data will be collected through household surveys, worker surveys, dairy value chain actor surveys, in-depth interviews (IDIs), and focus group discussions (FGDs). In Amhara Region, the protocol team has selected a subset of the intervention districts for the evaluation and identified an equal number of districts outside the program coverage area with similar characteristics to serve as the control.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Frequency of dairy consumption</measure>
      <time_frame>Baseline (August 2023), Endline (July 2026) (3 years)</time_frame>
      <description>Description (limit 999 characters) Change in the mean frequency of dairy consumption during the last 7 days by children 6 months to 7 years and workers</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frequency of nutritious food consumption</measure>
      <time_frame>Baseline (August 2023), Endline (July 2026) (3 years)</time_frame>
      <description>Change in the mean frequency of consumption of promoted nutritious foods (fortified oil, wheat flour, and fruits/vegetables) during the last 7 days by workers</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of available dairy and nutritious foods</measure>
      <time_frame>Baseline (August 2023), Endline (July 2026) (3 years)</time_frame>
      <description>Change in number of available dairy and target nutritious foods</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">3576</enrollment>
    <condition>Dairy Consumption</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>In Amhara, an equal number of districts outside the program coverage area with characteristics similar to the intervention districts will serve as the control.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Food system and demand generation</intervention_name>
      <description>GAIN's program to increase dairy consumption among BoP children and workers will include components to increase demand, improve access, and support the enabling environment. In Amhara, the demand generation component will share messages through radio, community influencers, and community conversations led by health extension workers targeting rural BoP households with children 6 months up to 7 years. GAIN will train milk houses and cooperatives on dairy safety and quality assurance and better business practices and will assist with cold chain and milk dispensing technology to improve milk availability and access. In industries and large-scale farms, GAIN will use a demand generation strategy to inform workers about the importance of dairy products and other nutritious foods and to encourage them to purchase them at their workplaces. GAIN will work with local businesses to launch and maintain dairy dispensers and arrange provision of other nutritious foods at work sites.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Household surveys&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Reside in the enumeration areas;&#xD;
  &#xD;
            -  Be a caregiver of at least one child 6 months to 7 years old residing in the&#xD;
               enumeration area;&#xD;
  &#xD;
            -  Be over 18 years old;&#xD;
  &#xD;
            -  The household is classified as BoP on Poverty Probability Index;&#xD;
  &#xD;
            -  Be able to speak Amharic;&#xD;
  &#xD;
            -  Provide informed consent to participate in the study.&#xD;
  &#xD;
          Dairy value chain semi-structured interviews&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be a manager or owner of small and medium enterprises (milk houses, milk processors,&#xD;
               or cooperatives) in the districts selected for the evaluation;&#xD;
  &#xD;
            -  Be over 18 years old;&#xD;
  &#xD;
            -  Be able to speak Amharic;&#xD;
  &#xD;
            -  Provide informed consent to participate in the study.&#xD;
  &#xD;
          FGDs with caregivers&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  Be a caregiver of a child 6 months up to 7 years old living in the intervention&#xD;
               districts selected for the evaluation;&#xD;
  &#xD;
            -  Be over 18 years old;&#xD;
  &#xD;
            -  Be able to speak Amharic;&#xD;
  &#xD;
            -  Provide informed consent to participate in the study.&#xD;
  &#xD;
          Worker surveys&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  Be a worker at an industry or large-scale farm where the owner/manager has agreed to&#xD;
               participate in GAIN's program;&#xD;
  &#xD;
            -  Be over 18 years old;&#xD;
  &#xD;
            -  Be able to speak one of the main local languages and/or Amharic;&#xD;
  &#xD;
            -  Provide informed consent to participate in the study.&#xD;
  &#xD;
          In-depth interviews with workers&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  Be an owner, worker, or food supplier connected to industries or large-scale farms&#xD;
               involved in GAIN's program in the intervention districts selected for the evaluation;&#xD;
  &#xD;
            -  Be over 18 years old;&#xD;
  &#xD;
            -  Be able to speak one of the main local languages and/or Amharic;&#xD;
  &#xD;
            -  Provide informed consent to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Netsanet Fentahun, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bahir Dar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Valerie Flax, PhD, MPH</last_name>
      <phone>9199908481</phone>
      <email>vflax@rti.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Frontieri</name>
        <address>
          <city>Addis Ababa</city>
          <country>Ethiopia</country>
        </address>
      </facility>
      <contact>
        <last_name>Dube Jara</last_name>
        <phone>251 91 112 5209</phone>
        <email>d.jara@bdscdr.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Ethiopia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>RTI International</investigator_affiliation>
      <investigator_full_name>Valerie Flax</investigator_full_name>
      <investigator_title>Senior Research Public Health Analyst</investigator_title>
    </responsible_party>
    <keyword>diet</keyword>
    <keyword>dairy</keyword>
    <keyword>market intervention</keyword>
    <keyword>social and behavior change communication intervention</keyword>
    <keyword>children</keyword>
    <keyword>workers</keyword>
    <keyword>Ethiopia</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Dataset will be shared through Nesstar.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971888
  org study id: 424603
  nct id: NCT05971888
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Global Alliance for Improved Nutrition (GAIN)'s "Better Dairy for All" program in Ethiopia
        seeks to improve children's and workers' consumption of healthy foods by improving access,
        increasing demand, and improving the enabling environment for dairy products by operating at
        multiple levels - individuals, households, markets, producers, and policies. RTI and local
        partners propose to conduct impact and process evaluations of GAIN's program tailored to the
        theory of change. The evaluation will include a mix of quantitative and qualitative methods
        and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and
        maintenance) evaluation framework.
  Background: Dairy products are excellent sources of calcium, vitamin A, and vitamin B12, and
        good sources of zinc, but are not widely consumed in Ethiopia. GAIN's Better Dairy for All
        program has two main components. One component is focused on increasing dairy consumption
        among children 6 months up to 7 years in bottom of the pyramid (BoP) households in Amhara
        Region through a demand generation campaign and support to milk houses, cooperatives, and
        processors. The other component is focused on increasing consumption of dairy and other
        nutritious foods by BoP workers in industries and large-scale farms by making dairy and other
        nutritious foods, such as fortified oil and fortified wheat flour and fruits/vegetables,
        available at their workplaces accompanied by demand generation activities.
  
        Objective: The objective of this study is to conduct an impact and process evaluation of
        GAIN's Better Dairy for All program.
  
        Methods: In Amhara, the evaluation will use a parallel group mixed-methods quasi-experimental
        before-after design to assess the effectiveness of the intervention on dairy consumption of
        children. The evaluation will be carried out in 64 enumeration areas (EAs) in intervention
        woredas matched on demographic characteristics with 64 EAs in control woredas. Data will be
        collected through household surveys, semi-structured interviews with dairy value chain
        actors, and focus group discussions (FGDs) with caregivers of young children. Cross-sectional
        population-based household surveys with caregivers of young children will be conducted at
        baseline (N=1,144) and endline (N=1,144) to assess intervention impact on dairy consumption
        frequency and quantity using difference-in-differences analysis. In the intervention woredas,
        evaluators will conduct semi-structured interviews to evaluate program outcomes with milk
        houses, milk processors, and cooperatives (N=30) at baseline, midline, and endline.
        Evaluators will also conduct FGDs with caregivers of young children (N=8 FGDs) at midline and
        endline in the intervention woredas. This data will be used for the process evaluation.
  
        In industries and large-scale farms, the evaluation of GAIN's program will use a
        cross-sectional pre-post design. The evaluation will be carried out in 5 purposefully
        selected industries/farms that start the intervention around the same time. Data will be
        collected through worker surveys, in-depth interviews (IDIs), and FGDs. Surveys with workers
        (N=524) will be conducted before and after the intervention to measure impacts of the program
        on workers' dairy consumption frequency and quantity. IDIs with industry/farm owners or
        managers and suppliers of dairy and other nutritious foods (N=5-10) and IDIs with workers
        (N=15) will be conducted at midline and endline. This data will be used for process
        evaluation.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Data will be collected through household surveys, worker surveys, dairy value chain actor surveys, in-depth interviews (IDIs), and focus group discussions (FGDs). In Amhara Region, the protocol team has selected a subset of the intervention districts for the evaluation and identified an equal number of districts outside the program coverage area with similar characteristics to serve as the control.
  primary purpose: Other
  masking: None (Open Label)
  measure: Frequency of dairy consumption
  time frame: Baseline (August 2023), Endline (July 2026) (3 years)
  description: Description (limit 999 characters) Change in the mean frequency of dairy consumption during the last 7 days by children 6 months to 7 years and workers
  measure: Frequency of nutritious food consumption
  time frame: Baseline (August 2023), Endline (July 2026) (3 years)
  description: Change in the mean frequency of consumption of promoted nutritious foods (fortified oil, wheat flour, and fruits/vegetables) during the last 7 days by workers
  measure: Number of available dairy and nutritious foods
  time frame: Baseline (August 2023), Endline (July 2026) (3 years)
  description: Change in number of available dairy and target nutritious foods
  arm group label: Intervention
  arm group type: Active Comparator
  arm group label: Control
  arm group type: No Intervention
  description: In Amhara, an equal number of districts outside the program coverage area with characteristics similar to the intervention districts will serve as the control.
  intervention type: Behavioral
  intervention name: Food system and demand generation
  description: GAIN's program to increase dairy consumption among BoP children and workers will include components to increase demand, improve access, and support the enabling environment. In Amhara, the demand generation component will share messages through radio, community influencers, and community conversations led by health extension workers targeting rural BoP households with children 6 months up to 7 years. GAIN will train milk houses and cooperatives on dairy safety and quality assurance and better business practices and will assist with cold chain and milk dispensing technology to improve milk availability and access. In industries and large-scale farms, GAIN will use a demand generation strategy to inform workers about the importance of dairy products and other nutritious foods and to encourage them to purchase them at their workplaces. GAIN will work with local businesses to launch and maintain dairy dispensers and arrange provision of other nutritious foods at work sites.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Netsanet Fentahun, PhD
  role: Principal Investigator
  affiliation: Bahir Dar University
  last name: Valerie Flax, PhD, MPH
  phone: 9199908481
  email: vflax@rti.org
  facility: 
  contact: 
  country: Ethiopia
  responsible party type: Principal Investigator
  investigator affiliation: RTI International
  investigator full name: Valerie Flax
  investigator title: Senior Research Public Health Analyst
  sharing ipd: Yes
  ipd description: Dataset will be shared through Nesstar.