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

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.

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.

Study Overview

• Status: Completed
• Conditions: Financial Stress
• Intervention / Treatment: Behavioral: Financial Education

• Study Type: Interventional
• Enrollment (Actual): 345
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • Creighton University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and one year later
Weight loss	The proportion of overweight or obese women that achieve a 5% or more reduction in weight	Baseline and one year later

Collaborators and Investigators

• Sponsor: Creighton University
• Investigators: Principal Investigator: Kathleen Packard, PharmD, PROFESSOR; Principal Investigator: Nicole White, PharmD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Financial Stress
• Other Study ID Numbers: 1011656-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No