<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/NCT03035240</url>
  </required_header>
  <id_info>
    <org_study_id>1011656-1</org_study_id>
    <nct_id>NCT03035240</nct_id>
  </id_info>
  <brief_title>Finances First: A Health Intervention in Low Income Single Mother Households</brief_title>
  <official_title>Finances First: A Health Intervention in Low Income Single Mother Households. A Prospective, Randomized, Controlled Trial to Assess the Effect of Financial Education on Health Outcomes in Single Mother Households.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Creighton University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Creighton 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>
      The purpose of this prospective, randomized, controlled three-year study is to compare the&#xD;
      effect of a year-long financial education program versus usual care on health outcomes in&#xD;
      single mother low income households.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Quality of Life as measured by the WHO QOL BREF survey</measure>
    <time_frame>Baseline and one year later</time_frame>
    <description>Changes in Quality of Life as measured by the WHO QOL BREF survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Baseline and one year later</time_frame>
    <description>The proportion of overweight or obese women that achieve a 5% or more reduction in weight</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">345</enrollment>
  <condition>Financial Stress</condition>
  <arm_group>
    <arm_group_label>Financial Education Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No Financial Education Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Financial Education</intervention_name>
    <description>Participants randomized to financial education will undergo a year long financial education. This involves 9 weeks of weekly classes followed by one on one coaching for a year.</description>
    <arm_group_label>Financial Education Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unmarried&#xD;
&#xD;
          -  Currently employed&#xD;
&#xD;
          -  Annual salary must be less than 200% of the Federal Poverty Guideline&#xD;
&#xD;
          -  Supporting at least one child at home&#xD;
&#xD;
          -  Able to read and speak either English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently abusing alcohol or recreational drugs&#xD;
&#xD;
          -  Currently living in a domestic violence situation&#xD;
&#xD;
          -  Pregnant or planning to become pregnant in the next year&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-identified women - this would include those that identify as women</gender_description>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Packard, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicole White, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Creighton University</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68178</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 27, 2021</last_update_submitted>
  <last_update_submitted_qc>January 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Financial Stress</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will only be shared with local Creighton Investigators listed on the study and the ICF. Individual participant data will not be shared outside of Creighton University.</ipd_description>
  </patient_data>
  <!-- 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/NCT03035240
org study id: 1011656-1
nct id: NCT03035240
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this prospective, randomized, controlled three-year study is to compare the
      effect of a year-long financial education program versus usual care on health outcomes in
      single mother low income households.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in Quality of Life as measured by the WHO QOL BREF survey
time frame: Baseline and one year later
description: Changes in Quality of Life as measured by the WHO QOL BREF survey
measure: Weight loss
time frame: Baseline and one year later
description: The proportion of overweight or obese women that achieve a 5% or more reduction in weight
arm group label: Financial Education Intervention
arm group type: Experimental
arm group label: No Financial Education Intervention
arm group type: No Intervention
intervention type: Behavioral
intervention name: Financial Education
description: Participants randomized to financial education will undergo a year long financial education. This involves 9 weeks of weekly classes followed by one on one coaching for a year.
arm group label: Financial Education Intervention
criteria: 
gender: Female
gender based: Yes
gender description: Self-identified women - this would include those that identify as women
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen Packard, PharmD
role: Principal Investigator
affiliation: Professor
last name: Nicole White, PharmD
role: Principal Investigator
affiliation: Associate Professor
facility: 
country: United States
responsible party type: Sponsor
mesh term: Financial Stress
sharing ipd: No
ipd description: Individual participant data will only be shared with local Creighton Investigators listed on the study and the ICF. Individual participant data will not be shared outside of Creighton University.