NCT03035240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 2, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 28, 2021

Status Verified

October 1, 2020

Enrollment Period

3.4 years

First QC Date

January 26, 2017

Last Update Submit

January 27, 2021

Conditions

Financial Stress

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Financial Education Intervention

EXPERIMENTAL
Behavioral: Financial Education

No Financial Education Intervention

NO INTERVENTION

Interventions

Financial EducationBEHAVIORAL

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.

Financial Education Intervention

Eligibility Criteria

Age19 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identified women - this would include those that identify as women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Conditions

Financial Stress

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Kathleen Packard, PharmD

    Professor

    PRINCIPAL INVESTIGATOR

  • Nicole White, PharmD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 27, 2017

Study Start

May 2, 2017

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

January 28, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)