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

Primary Purpose

Financial Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial Education
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Financial Stress

Eligibility Criteria

19 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Creighton University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Financial Education Intervention

No Financial Education Intervention

Arm Description

Outcomes

Primary Outcome Measures

Changes in Quality of Life as measured by the WHO QOL BREF survey
Changes in Quality of Life as measured by the WHO QOL BREF survey
Weight loss
The proportion of overweight or obese women that achieve a 5% or more reduction in weight

Secondary Outcome Measures

Full Information

First Posted
January 26, 2017
Last Updated
January 27, 2021
Sponsor
Creighton University
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1. Study Identification

Unique Protocol Identification Number
NCT03035240
Brief Title
Finances First: A Health Intervention in Low Income Single Mother Households
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Financial Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Financial Education Intervention
Arm Type
Experimental
Arm Title
No Financial Education Intervention
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Financial Education
Intervention 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.
Primary Outcome Measure Information:
Title
Changes in Quality of Life as measured by the WHO QOL BREF survey
Description
Changes in Quality of Life as measured by the WHO QOL BREF survey
Time Frame
Baseline and one year later
Title
Weight loss
Description
The proportion of overweight or obese women that achieve a 5% or more reduction in weight
Time Frame
Baseline and one year later

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-identified women - this would include those that identify as women
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Packard, PharmD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole White, PharmD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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