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

• Sponsor: Creighton University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03035240
• Collaborator: (none)
• Enrollment: 345
• Location: 1
• Arms: 2
• Actual Duration (Months): 41
• Patients Per Site Per Month: 8.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Financial Stress	Behavioral: Financial Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 345 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
• Actual Primary Completion Date: Oct 1, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in Quality of Life as measured by the WHO QOL BREF survey [Baseline and one year later]

   Changes in Quality of Life as measured by the WHO QOL BREF survey

2. Weight loss [Baseline and one year later]

   The proportion of overweight or obese women that achieve a 5% or more reduction in weight

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Creighton University	Omaha	Nebraska	United States	68178

Sponsors and Collaborators

• Creighton University

Investigators

• Principal Investigator: Kathleen Packard, PharmD, Professor
• Principal Investigator: Nicole White, PharmD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Creighton University
• ClinicalTrials.gov Identifier: NCT03035240
• Other Study ID Numbers: 1011656-1
• First Posted: Jan 27, 2017
• Last Update Posted: Jan 28, 2021
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Financial Stress

Study Results

No Results Posted as of Jan 28, 2021