<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/NCT03305406</url>
  </required_header>
  <id_info>
    <org_study_id>34482-2</org_study_id>
    <nct_id>NCT03305406</nct_id>
  </id_info>
  <brief_title>Parkdale Infant Nutrition Security Targeted Evaluation Project: Focus Groups &amp; Interviews</brief_title>
  <acronym>PINSTEP-2</acronym>
  <official_title>Parkdale Infant Nutrition Security Targeted Evaluation Project (PINSTEP): Formative Research (Objective 2-Focus Group &amp; Interview)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach&#xD;
      program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides&#xD;
      weekly pre- and post-natal support and education programs for clients. This includes an&#xD;
      infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has&#xD;
      a diverse client-base; the program is aimed at women who are in challenging life&#xD;
      circumstances, therefore, clients may include low-income or single mothers and newcomers to&#xD;
      Canada.&#xD;
&#xD;
      The overall goal of this research is to optimize the existing 5P's program. Program&#xD;
      acceptability is an essential component of the process evaluation to understand the&#xD;
      experiences of mothers and the perceived supports and barriers of the program. Specifically,&#xD;
      the aim of this project is twofold: 1) to investigate the perceptions and experiences of&#xD;
      accessibility of a postnatal community program and 2) to explore the perceptions of, and&#xD;
      attitudes toward, a community infant feeding program offering lactation consultant and breast&#xD;
      pump resources. This study will use a qualitative approach by way of semi-structured focus&#xD;
      groups and interviews. The study population will consist of women who enrolled in 5P's&#xD;
      prenatally and have delivered their infant. This will include women who did and did not&#xD;
      continue to participate in the postnatal program and/or Feeding Tiny Souls after delivery.&#xD;
      The investigators will specifically seek women who participated in the prenatal program, but&#xD;
      did not take part in the postnatal program and/or Feeding Tiny Souls to understand why&#xD;
      participants did not access these resources and gather information on their views of these&#xD;
      postnatal program components. The hypothesis is that the postnatal community program is a&#xD;
      source of support for clients, but that it needs to be expanded to include more clients and&#xD;
      the infant feeding program is an important support for helping clients to provide breast milk&#xD;
      to their infant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2017</start_date>
  <completion_date type="Actual">December 20, 2017</completion_date>
  <primary_completion_date type="Actual">December 20, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Perceptions of, and attitudes toward, a community infant feeding program offering lactation consultant and breast pump resources as assessed by group responses to targeted probes during postnatal focus groups and interviews</measure>
    <time_frame>60 minutes (participants are 1-14 months postpartum)</time_frame>
    <description>Qualitative summary of perceptions and attitudes regarding a community infant feeding program</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceptions and experiences of accessibility of a postnatal community program as assessed by group responses to targeted probes during postnatal focus groups and interviews</measure>
    <time_frame>60 minutes (participants are 1-14 months postpartum)</time_frame>
    <description>Qualitative summary of perceptions and experiences of accessibility regarding a community infant feeding program</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">51</enrollment>
  <condition>Breastfeeding</condition>
  <condition>Breast Pumping</condition>
  <condition>Infant Nutrition</condition>
  <condition>Vulnerable Population</condition>
  <arm_group>
    <arm_group_label>Focus Group Participants</arm_group_label>
    <description>Semi-structured focus groups</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interview Participants</arm_group_label>
    <description>One-on-one interviews</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Focus groups</intervention_name>
    <description>Focus groups will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition</description>
    <arm_group_label>Focus Group Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interviews</intervention_name>
    <description>Interviews will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition</description>
    <arm_group_label>Interview Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Clients enrolled in the Parkdale Parents' Primary Prevention Project (5P's) at the Parkdale&#xD;
        Community Health Centre in Toronto, Ontario, Canada&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally&#xD;
&#xD;
          -  Delivered their infant between June 1, 2016 and August 16, 2017&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unavailable to participate in a focus group or interview&#xD;
&#xD;
          -  Only attended Parkdale Parents' Primary Prevention Project (5P's) postnatally&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane Francis, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkdale Community Health Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6R 3B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Francis J, Mildon A, Stewart S, Underhill B, Tarasuk V, Di Ruggiero E, Sellen D, O'Connor DL. Vulnerable mothers' experiences breastfeeding with an enhanced community lactation support program. Matern Child Nutr. 2020 Jul;16(3):e12957. doi: 10.1111/mcn.12957. Epub 2020 Jan 26.</citation>
    <PMID>31984642</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Daniel Sellen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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/NCT03305406
org study id: 34482-2
nct id: NCT03305406
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach
      program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides
      weekly pre- and post-natal support and education programs for clients. This includes an
      infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has
      a diverse client-base; the program is aimed at women who are in challenging life
      circumstances, therefore, clients may include low-income or single mothers and newcomers to
      Canada.

      The overall goal of this research is to optimize the existing 5P's program. Program
      acceptability is an essential component of the process evaluation to understand the
      experiences of mothers and the perceived supports and barriers of the program. Specifically,
      the aim of this project is twofold: 1) to investigate the perceptions and experiences of
      accessibility of a postnatal community program and 2) to explore the perceptions of, and
      attitudes toward, a community infant feeding program offering lactation consultant and breast
      pump resources. This study will use a qualitative approach by way of semi-structured focus
      groups and interviews. The study population will consist of women who enrolled in 5P's
      prenatally and have delivered their infant. This will include women who did and did not
      continue to participate in the postnatal program and/or Feeding Tiny Souls after delivery.
      The investigators will specifically seek women who participated in the prenatal program, but
      did not take part in the postnatal program and/or Feeding Tiny Souls to understand why
      participants did not access these resources and gather information on their views of these
      postnatal program components. The hypothesis is that the postnatal community program is a
      source of support for clients, but that it needs to be expanded to include more clients and
      the infant feeding program is an important support for helping clients to provide breast milk
      to their infant.
observational model: Cohort
time perspective: Prospective
measure: Perceptions of, and attitudes toward, a community infant feeding program offering lactation consultant and breast pump resources as assessed by group responses to targeted probes during postnatal focus groups and interviews
time frame: 60 minutes (participants are 1-14 months postpartum)
description: Qualitative summary of perceptions and attitudes regarding a community infant feeding program
measure: Perceptions and experiences of accessibility of a postnatal community program as assessed by group responses to targeted probes during postnatal focus groups and interviews
time frame: 60 minutes (participants are 1-14 months postpartum)
description: Qualitative summary of perceptions and experiences of accessibility regarding a community infant feeding program
arm group label: Focus Group Participants
description: Semi-structured focus groups
arm group label: Interview Participants
description: One-on-one interviews
intervention type: Other
intervention name: Focus groups
description: Focus groups will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition
arm group label: Focus Group Participants
intervention type: Other
intervention name: Interviews
description: Interviews will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition
arm group label: Interview Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jane Francis, MSc
role: Principal Investigator
affiliation: University of Toronto
facility: 
country: Canada
citation: Francis J, Mildon A, Stewart S, Underhill B, Tarasuk V, Di Ruggiero E, Sellen D, O'Connor DL. Vulnerable mothers' experiences breastfeeding with an enhanced community lactation support program. Matern Child Nutr. 2020 Jul;16(3):e12957. doi: 10.1111/mcn.12957. Epub 2020 Jan 26.
PMID: 31984642
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Daniel Sellen
investigator title: Professor