Financial StressNCT03035240
Finances First: A Health Intervention in Low Income Single Mother Households
A study testing Financial Education in people with Financial Stress, run by Creighton University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Financial Stress
- What is being tested?
- Financial Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2017to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Currently abusing alcohol or recreational drugs
- Currently living in a domestic violence situation
- Pregnant or planning to become pregnant in the next year
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Financial Stress
- Being tested
- Financial Education
- Medical subject headings
- Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Financial Education Intervention | Experimental | Not described Receives: Behavioral: Financial Education |
| No Financial Education Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and one year later
Weight loss
The proportion of overweight or obese women that achieve a 5% or more reduction in weight
Measured: Baseline and one year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start2 May 2017
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Financial StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Packard, PharmD, Principal investigator, ProfessorNicole White, PharmD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035240
- Sponsor's protocol ID
- 1011656-1
- Status last verified
- Oct 2020
- First submitted
- 26 Jan 2017
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03035240
- Acronym / sponsor ID
- 1011656-1
- Conditions
- Financial Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Financial Education Intervention | Experimental | Behavioral: Financial Education |
| No Financial Education Intervention | No intervention | – |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Currently abusing alcohol or recreational drugs
- Currently living in a domestic violence situation
- Pregnant or planning to become pregnant in the next year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial EducationParticipants 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. | Behavioural | Financial Education Intervention |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Packard, PharmD principal investigator
Professor
Nicole White, PharmD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Education in people with Financial Stress, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Quality of Life as measured by the WHO QOL BREF survey (time frame: Baseline and one year later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.