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/NCT05992376</url>
    </required_header>
    <id_info>
      <org_study_id>424604</org_study_id>
      <nct_id>NCT05992376</nct_id>
    </id_info>
    <brief_title>Vegetables for All Evaluation Kenya</brief_title>
    <official_title>Impact Evaluation of the Global Alliance for Improved Nutrition (GAIN) Vegetables for All Program in Kenya</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RTI International</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kula Vyema Centre of Food Economics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Jomo Kenyatta University of Agriculture and Technology (JKUAT)</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;Vegetables for All&quot; program in Kenya seeks&#xD;
        to improve consumption of healthy foods by improving supply, increasing demand, and improving&#xD;
        the enabling environment for different vegetables by operating at multiple levels -&#xD;
        individuals, households, markets, producers, and policies. RTI and local partners propose to&#xD;
        conduct impact and process evaluations of GAIN's program tailored to the theory of change.&#xD;
        The evaluation will include a mix of quantitative and qualitative methods and will be guided&#xD;
        by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) evaluation&#xD;
        framework.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: In urban and peri-urban areas in Kenya, Consumption of vegetables is low in&#xD;
        bottom of pyramid (BoP) households, which earn &lt; 3.20 US dollars per person per day. To&#xD;
        increase vegetable consumption in this population, GAIN will implement the Vegetables for All&#xD;
        program, which aims to improve access to safe and fresh vegetables in Fit Food Zones (FFZs)&#xD;
        and to generate demand for vegetables through a radio/television campaign and FFZ branding.&#xD;
        The main retailers in the FFZ are mama mbogas (vegetable vendors), who will be linked to&#xD;
        suppliers that are Good Agricultural Practices (GAP) compliant.&#xD;
  &#xD;
        Objective: The overall objectives of the evaluation are: 1) to assess the effectiveness of&#xD;
        GAIN's Vegetables for All program for increasing the quantity of vegetables consumed and&#xD;
        improving the diet quality of BoP consumers and 2) to conduct a process evaluation of GAIN's&#xD;
        program that provides data to support findings of the impact evaluation.&#xD;
  &#xD;
        Methods: This study will use a mixed-methods quasi-experimental design in which 124 FFZs are&#xD;
        assigned to intervention or control in Nairobi, Kiambu, Machakos, Mombasa, and Nakuru&#xD;
        counties. The impacts will be assessed through cross-sectional population-based surveys of&#xD;
        households with women 18-49 years who have a child 3-11 years in 62 intervention and 62&#xD;
        control FFZs at baseline and endline (N=1,364 at each time point). Mama mboga surveys will be&#xD;
        conducted in all 124 sampled FFZs at baseline, midline, and endline (N=372 at each time&#xD;
        point). Qualitative data will be collected at midline and endline. In-depth interviews (IDIs)&#xD;
        will be conducted with vegetable value chain actors and other stakeholders (N=18 at each time&#xD;
        point). Focus group discussions (FGDs) will be conducted with mama mbogas (20 FGDs at each&#xD;
        time point) and household members (20 FGDs at each time point). The analysis will be&#xD;
        performed using difference-in-difference estimation (surveys) and thematic content analysis&#xD;
        methods (qualitative).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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, mama mboga surveys, in-depth interviews (IDIs), and focus group discussions (FGDs). The protocol team has selected a subset of intervention FFZs for the evaluation and identified an equal number of geographic areas of similar size and level of urbanicity to serve as the controls.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Grams of Vegetables Consumed</measure>
      <time_frame>Baseline (September 2023), endline (September 2025) (2 years)</time_frame>
      <description>Change in the mean grams of vegetables consumed during the last 24 hours by children 3-11 years old in BoP households in Fit Food Zones</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">4680</enrollment>
    <condition>Vegetable 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/No Intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Food system and demand generation</intervention_name>
      <description>The Vegetables for All program will create FitFood Zones (FFZs) in low-income estates in urban and peri-urban areas with a minimum of 1,000 households and 10 mama mbogas. FFZs are the last mile/point of purchase for delivering a variety of fresh, safe, and accessible vegetables to BoP households. The program will support mama mbogas to source vegetables from Good Agricultural Practices (GAP)-compliant suppliers, support the uptake of digital solutions for mama mbogas to access vegetables, create business-to-business mentorship opportunities, and support county governments to improve market infrastructure. To encourage BoP parents of children 3-11 years to buy and consume more vegetables, the program will include a demand generation component. This will be implemented through a communication campaign, including above-the-line (ATL) activities (mass media such as radio and television), below-the-line (BTL) activities (market activations and others), and FFZ branding.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Household Surveys&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Reside in the FFZs assigned;&#xD;
  &#xD;
            -  Be a woman between 18-49 years old;&#xD;
  &#xD;
            -  Have a child 3-12 years old&#xD;
  &#xD;
            -  The household earns &lt;$3.20 per person per day;&#xD;
  &#xD;
            -  Be able to speak one of the main local languages and/or Kiswahili;&#xD;
  &#xD;
            -  Provide informed consent to participate in the study.&#xD;
  &#xD;
          Mama Mboga Surveys&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be a mama mboga retailer of vegetables in a FFZ in the districts selected for the&#xD;
               evaluation;&#xD;
  &#xD;
            -  Be in business for at least 6 months&#xD;
  &#xD;
            -  Be over 18 years old;&#xD;
  &#xD;
            -  Be able to speak one of the main local languages and/or Kiswahili;&#xD;
  &#xD;
            -  Provide informed consent to participate in the study.&#xD;
  &#xD;
          In-depth interviews with value chain actors&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  Be a vegetable supplier to mama mbogas as part of the FFZ, are involved in demand&#xD;
               generation activities, or involved in food safety compliance;&#xD;
  &#xD;
            -  Be over 18 years old;&#xD;
  &#xD;
            -  Be able to speak one of the main local languages and/or Kiswahili;&#xD;
  &#xD;
            -  Provide informed consent to participate in the study.&#xD;
  &#xD;
          Focus group discussion (FGD) participants will be selected from lists of participants in&#xD;
          the FFZ and household surveys and will be consented again for the FGDs if they meet the&#xD;
          following criteria:&#xD;
  &#xD;
          FGDs with households&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  Be a woman living in a BoP household in a FFZ selected for the evaluation;&#xD;
  &#xD;
            -  Have ever visited a mama mboga's place of business&#xD;
  &#xD;
            -  Participated in the baseline survey&#xD;
  &#xD;
            -  Be over 18 years old;&#xD;
  &#xD;
            -  Be able to speak one of the main local languages and/or Kiswahili;&#xD;
  &#xD;
            -  Provide informed consent to participate in the study.&#xD;
  &#xD;
          FGDs with mama mbogas&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  Be a mama mboga linked to the Vegetables for All project in one of the intervention&#xD;
               FFZs&#xD;
  &#xD;
            -  Have been a mama mboga for at least 6 months&#xD;
  &#xD;
            -  Be over 18 years old;&#xD;
  &#xD;
            -  Be able to speak one of the main local languages and/or Kiswahili;&#xD;
  &#xD;
            -  Provide informed consent to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Simon Kimenju, PhD, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kula Vyema Centre of Food Economics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Valerie Flax, PhD, MPH</last_name>
      <phone>1-919-990-8481</phone>
      <email>vflax@rti.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kula Vyema Centre of Food Economics</name>
        <address>
          <city>Kiambu</city>
          <country>Kenya</country>
        </address>
      </facility>
      <contact>
        <last_name>Simon Kimenju, PhD, MSc</last_name>
        <email>skimenju@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Simon Kimenju, PhD, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Florence Kyallo, PhD, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Valerie Flax, PhD, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Kenya</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 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>vegetables</keyword>
    <keyword>market intervention</keyword>
    <keyword>social and behavior change communication intervention</keyword>
    <keyword>children</keyword>
    <keyword>Kenya</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/NCT05992376
  org study id: 424604
  nct id: NCT05992376
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Global Alliance for Improved Nutrition (GAIN)'s "Vegetables for All" program in Kenya seeks
        to improve consumption of healthy foods by improving supply, increasing demand, and improving
        the enabling environment for different vegetables 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: In urban and peri-urban areas in Kenya, Consumption of vegetables is low in
        bottom of pyramid (BoP) households, which earn < 3.20 US dollars per person per day. To
        increase vegetable consumption in this population, GAIN will implement the Vegetables for All
        program, which aims to improve access to safe and fresh vegetables in Fit Food Zones (FFZs)
        and to generate demand for vegetables through a radio/television campaign and FFZ branding.
        The main retailers in the FFZ are mama mbogas (vegetable vendors), who will be linked to
        suppliers that are Good Agricultural Practices (GAP) compliant.
  
        Objective: The overall objectives of the evaluation are: 1) to assess the effectiveness of
        GAIN's Vegetables for All program for increasing the quantity of vegetables consumed and
        improving the diet quality of BoP consumers and 2) to conduct a process evaluation of GAIN's
        program that provides data to support findings of the impact evaluation.
  
        Methods: This study will use a mixed-methods quasi-experimental design in which 124 FFZs are
        assigned to intervention or control in Nairobi, Kiambu, Machakos, Mombasa, and Nakuru
        counties. The impacts will be assessed through cross-sectional population-based surveys of
        households with women 18-49 years who have a child 3-11 years in 62 intervention and 62
        control FFZs at baseline and endline (N=1,364 at each time point). Mama mboga surveys will be
        conducted in all 124 sampled FFZs at baseline, midline, and endline (N=372 at each time
        point). Qualitative data will be collected at midline and endline. In-depth interviews (IDIs)
        will be conducted with vegetable value chain actors and other stakeholders (N=18 at each time
        point). Focus group discussions (FGDs) will be conducted with mama mbogas (20 FGDs at each
        time point) and household members (20 FGDs at each time point). The analysis will be
        performed using difference-in-difference estimation (surveys) and thematic content analysis
        methods (qualitative).
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Data will be collected through household surveys, mama mboga surveys, in-depth interviews (IDIs), and focus group discussions (FGDs). The protocol team has selected a subset of intervention FFZs for the evaluation and identified an equal number of geographic areas of similar size and level of urbanicity to serve as the controls.
  primary purpose: Other
  masking: None (Open Label)
  measure: Grams of Vegetables Consumed
  time frame: Baseline (September 2023), endline (September 2025) (2 years)
  description: Change in the mean grams of vegetables consumed during the last 24 hours by children 3-11 years old in BoP households in Fit Food Zones
  arm group label: Intervention
  arm group type: Active Comparator
  arm group label: Control/No Intervention
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: Food system and demand generation
  description: The Vegetables for All program will create FitFood Zones (FFZs) in low-income estates in urban and peri-urban areas with a minimum of 1,000 households and 10 mama mbogas. FFZs are the last mile/point of purchase for delivering a variety of fresh, safe, and accessible vegetables to BoP households. The program will support mama mbogas to source vegetables from Good Agricultural Practices (GAP)-compliant suppliers, support the uptake of digital solutions for mama mbogas to access vegetables, create business-to-business mentorship opportunities, and support county governments to improve market infrastructure. To encourage BoP parents of children 3-11 years to buy and consume more vegetables, the program will include a demand generation component. This will be implemented through a communication campaign, including above-the-line (ATL) activities (mass media such as radio and television), below-the-line (BTL) activities (market activations and others), and FFZ branding.
  arm group label: Intervention
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Simon Kimenju, PhD, MSc
  role: Principal Investigator
  affiliation: Kula Vyema Centre of Food Economics
  last name: Valerie Flax, PhD, MPH
  phone: 1-919-990-8481
  email: vflax@rti.org
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Kenya
  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.