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Finances First: A Health Intervention in Low Income Single Mother Households

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ClinicalTrials.gov Identifier: NCT03035240
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Creighton University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Financial Stress Behavioral: Financial Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Arm Intervention/treatment
Experimental: Financial Education Intervention Behavioral: Financial Education
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.

No Intervention: No Financial Education Intervention



Primary Outcome Measures :
  1. Changes in Quality of Life as measured by the WHO QOL BREF survey [ Time Frame: Baseline and one year later ]
    Changes in Quality of Life as measured by the WHO QOL BREF survey

  2. Weight loss [ Time Frame: Baseline and one year later ]
    The proportion of overweight or obese women that achieve a 5% or more reduction in weight



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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identified women - this would include those that identify as women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unmarried
  • Currently employed
  • Annual salary must be less than 200% of the Federal Poverty Guideline
  • Supporting at least one child at home
  • Able to read and speak either English or Spanish

Exclusion Criteria:

  • Currently abusing alcohol or recreational drugs
  • Currently living in a domestic violence situation
  • Pregnant or planning to become pregnant in the next year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035240


Contacts
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Contact: Kathleen Packard, PharmD 402-481-3915 kpackard@creighton.edu
Contact: Nicole White, PharmD 402-280-2791 nicolewhite@creighton.edu

Locations
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United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68178
Contact: Kathleen Packard, PharmD    402-481-3915    kpackard@creighton.edu   
Sponsors and Collaborators
Creighton University
Investigators
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Principal Investigator: Kathleen Packard, PharmD Professor
Principal Investigator: Nicole White, PharmD Associate Professor

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Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT03035240     History of Changes
Other Study ID Numbers: 1011656-1
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No