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/NCT05967234</url>
    </required_header>
    <id_info>
      <org_study_id>IRB # 308</org_study_id>
      <nct_id>NCT05967234</nct_id>
    </id_info>
    <brief_title>THIS-WIC Vermont Breastfeeding Education Application Feasibility Study</brief_title>
    <official_title>THIS-WIC Vermont Breastfeeding Education Application Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tufts University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>U.S. Department of Agriculture</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Vermont WIC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>RTI International</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Tufts University</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>
        With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC&#xD;
        (THIS-WIC) project, the Vermont WIC department will be conducting a feasibility study of a&#xD;
        mobile telehealth solution for breastfeeding education. The purpose of this study is to&#xD;
        evaluate this telehealth solution. The research/evaluation involves completing online surveys&#xD;
        and interviews. The evaluation will focus on participant satisfaction, usage of the&#xD;
        telehealth solution, and use of information collected on WIC participant through the WIC&#xD;
        management information system (MIS) and the telehealth platform. It is hypothesized that the&#xD;
        telehealth solution will increase WIC participant's satisfaction with breastfeeding&#xD;
        education.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Telehealth can reduce barriers and increase access to care, and it can be applied to the&#xD;
        Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). WIC is a&#xD;
        federal nutrition assistance program that helps low-income women with children up to age 5.&#xD;
        There is a large volume of research that supports remote patient monitoring, and the most&#xD;
        benefits are found when telehealth is used for communication and counseling. The USDA awarded&#xD;
        Tufts University a grant to test and evaluate the use of telehealth innovations in the&#xD;
        delivery of USDA's WIC program. Tufts University then offered the USDA/Tufts Telehealth&#xD;
        Intervention Strategies for WIC (THIS-WIC) grant opportunity to WIC state agencies across the&#xD;
        US. THIS-WIC selected 7 WIC State Agencies to receive grants, and the Vermont state agency is&#xD;
        one recipient. The THIS-WIC team at Tufts University is leading the evaluation of these&#xD;
        telehealth solutions in collaboration with funded WIC State Agencies.&#xD;
  &#xD;
        THIS-WIC aims to generate evidence from Vermont's telehealth solution to inform how the&#xD;
        telehealth platform supports WIC services . Evaluation findings will inform stakeholders&#xD;
        about the platform's benefits and how viable it is to sustain and adapt more widely.&#xD;
  &#xD;
        The purpose of this study is to evaluate the effectiveness of this telehealth solution by&#xD;
        having clients complete surveys and interviews on their comfortability using telehealth and&#xD;
        their satisfaction with the telehealth solution. Additionally, information about usage will&#xD;
        be collected from the telehealth platform, and secondary demographic and other&#xD;
        nutrition-related information about study participants is already collected in the MIS and&#xD;
        will be utilized.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 26, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 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>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Study participants will be clients at local WIC agency sites where the telehealth solution is offered</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Satisfaction with the telehealth solution</measure>
      <time_frame>During the study period, approximately 12 months</time_frame>
      <description>WIC clients satisfaction with breastfeeding education offered via the telehealth solution. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Frequency of use of the telehealth solution</measure>
      <time_frame>During the study period, approximately 12 months</time_frame>
      <description>The frequency with which WIC clients use the telehealth solution. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intent to breastfeed</measure>
      <time_frame>During the study period, approximately 12 months</time_frame>
      <description>WIC clients intent to breastfeed. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Breastfeeding duration</measure>
      <time_frame>During the study period, approximately 12 months</time_frame>
      <description>Duration of breastfeeding in clients offered the telehealth solution. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attitudes to breastfeeding</measure>
      <time_frame>During the study period, approximately 12 months</time_frame>
      <description>Impact of the telehealth solution on WIC clients' attitudes to breastfeeding. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Barriers encountered in use of the telehealth solution and breastfeeding</measure>
      <time_frame>During the study period, approximately 12 months</time_frame>
      <description>Barriers encountered by WIC clients in use of the telehealth solution and in breastfeeding. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Telehealth</condition>
    <condition>Breast Feeding</condition>
    <condition>WIC</condition>
    <arm_group>
      <arm_group_label>Telehealth solution</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Telehealth solution offered for breastfeeding education.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Telehealth solution</intervention_name>
      <description>Telehealth solution offered for breastfeeding education.</description>
      <arm_group_label>Telehealth solution</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Speaks and reads English (as the telehealth solution is available in English)&#xD;
  &#xD;
            -  Pregnant or postpartum&#xD;
  &#xD;
            -  Has access to a smart phone or smart device (e.g. iPad or tablet)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>Female</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>Erin Hennessy, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tufts University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Catherine Wright, MS</last_name>
      <phone>617-636-0436</phone>
      <email>catherine.wright@tufts.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shanti Sharma, PhD</last_name>
      <phone>617-636-0312</phone>
      <email>shanti.sharma@tufts.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tufts University</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02111</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Catherine Wright, MS</last_name>
        <phone>617-636-0436</phone>
        <email>catherine.wright@tufts.edu</email>
      </contact>
      <contact_backup>
        <last_name>Shanti Sharma, PhD</last_name>
        <phone>617-636-0312</phone>
        <email>shanti.sharma@tufts.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Erin Hennessy, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://thiswic.nutrition.tufts.edu/</url>
      <description>Tufts Telehealth Intervention Strategies for WIC (THIS-WIC)</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tufts University</investigator_affiliation>
      <investigator_full_name>Erin Hennessy</investigator_full_name>
      <investigator_title>Assistant Professor, Division of Nutrition Interventions, Communication and Behavior Change Director ad interim, ChildObesity180 Friedman School of Nutrition Science and Policy</investigator_title>
    </responsible_party>
    <keyword>Telehealth</keyword>
    <keyword>WIC</keyword>
    <keyword>Breast feeding</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05967234
  org study id: IRB # 308
  nct id: NCT05967234
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC
        (THIS-WIC) project, the Vermont WIC department will be conducting a feasibility study of a
        mobile telehealth solution for breastfeeding education. The purpose of this study is to
        evaluate this telehealth solution. The research/evaluation involves completing online surveys
        and interviews. The evaluation will focus on participant satisfaction, usage of the
        telehealth solution, and use of information collected on WIC participant through the WIC
        management information system (MIS) and the telehealth platform. It is hypothesized that the
        telehealth solution will increase WIC participant's satisfaction with breastfeeding
        education.
  Telehealth can reduce barriers and increase access to care, and it can be applied to the
        Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). WIC is a
        federal nutrition assistance program that helps low-income women with children up to age 5.
        There is a large volume of research that supports remote patient monitoring, and the most
        benefits are found when telehealth is used for communication and counseling. The USDA awarded
        Tufts University a grant to test and evaluate the use of telehealth innovations in the
        delivery of USDA's WIC program. Tufts University then offered the USDA/Tufts Telehealth
        Intervention Strategies for WIC (THIS-WIC) grant opportunity to WIC state agencies across the
        US. THIS-WIC selected 7 WIC State Agencies to receive grants, and the Vermont state agency is
        one recipient. The THIS-WIC team at Tufts University is leading the evaluation of these
        telehealth solutions in collaboration with funded WIC State Agencies.
  
        THIS-WIC aims to generate evidence from Vermont's telehealth solution to inform how the
        telehealth platform supports WIC services . Evaluation findings will inform stakeholders
        about the platform's benefits and how viable it is to sustain and adapt more widely.
  
        The purpose of this study is to evaluate the effectiveness of this telehealth solution by
        having clients complete surveys and interviews on their comfortability using telehealth and
        their satisfaction with the telehealth solution. Additionally, information about usage will
        be collected from the telehealth platform, and secondary demographic and other
        nutrition-related information about study participants is already collected in the MIS and
        will be utilized.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Study participants will be clients at local WIC agency sites where the telehealth solution is offered
  primary purpose: Other
  masking: None (Open Label)
  measure: Satisfaction with the telehealth solution
  time frame: During the study period, approximately 12 months
  description: WIC clients satisfaction with breastfeeding education offered via the telehealth solution. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
  measure: Frequency of use of the telehealth solution
  time frame: During the study period, approximately 12 months
  description: The frequency with which WIC clients use the telehealth solution. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
  measure: Intent to breastfeed
  time frame: During the study period, approximately 12 months
  description: WIC clients intent to breastfeed. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
  measure: Breastfeeding duration
  time frame: During the study period, approximately 12 months
  description: Duration of breastfeeding in clients offered the telehealth solution. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
  measure: Attitudes to breastfeeding
  time frame: During the study period, approximately 12 months
  description: Impact of the telehealth solution on WIC clients' attitudes to breastfeeding. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
  measure: Barriers encountered in use of the telehealth solution and breastfeeding
  time frame: During the study period, approximately 12 months
  description: Barriers encountered by WIC clients in use of the telehealth solution and in breastfeeding. Data will be collected, and this outcome measure will be assessed via survey completion by study participants.
  arm group label: Telehealth solution
  arm group type: Experimental
  description: Telehealth solution offered for breastfeeding education.
  intervention type: Behavioral
  intervention name: Telehealth solution
  description: Telehealth solution offered for breastfeeding education.
  arm group label: Telehealth solution
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Erin Hennessy, PhD
  role: Principal Investigator
  affiliation: Tufts University
  last name: Catherine Wright, MS
  phone: 617-636-0436
  email: catherine.wright@tufts.edu
  last name: Shanti Sharma, PhD
  phone: 617-636-0312
  email: shanti.sharma@tufts.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  url: https://thiswic.nutrition.tufts.edu/
  description: Tufts Telehealth Intervention Strategies for WIC (THIS-WIC)
  responsible party type: Principal Investigator
  investigator affiliation: Tufts University
  investigator full name: Erin Hennessy
  investigator title: Assistant Professor, Division of Nutrition Interventions, Communication and Behavior Change Director ad interim, ChildObesity180 Friedman School of Nutrition Science and Policy
  sharing ipd: No