StressNCT01409291
Impact of a Financial Success Education Program in Women and Children
An observational study of Stress, run by Creighton University at 1 site in United States.
Trial summary
Many Americans are living paycheck to paycheck. This may lead to financial stress and an increase in overall stress. People under stress are more likely to smoke, consume alcohol, eat a poor diet, and experience depression or anxiety. Experiencing financial stress may also increase the risk for heart disease. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Stress
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women enrolled in the Financial Success Program and their children
Who may be able to join
- Women 19 years or older enrolled in the Financial Success Program in fall 2011 and winter 2012 and/or a their child(ren) ages 3-18 years attending the daycare with their mother
- Women must be employed to be enrolled in the Financial Success Program
- Able and willing to provide informed consent
Who cannot join
- Women less than 19 years of age
- Women working a night time shift (due to variability in diurnal cortisol secretion)
- Known pregnancy or planned pregnancy (due to variability in blood pressure, glucose, weight, and lipids)
- Women are excluded from the Financial Success Program if they are living in a domestic violence situation or abusing alcohol or illicit drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Financial Success Education Program on Perceived Financial Well-being, Hopefulness, Financial Competency, Financial Goal Achievement, Quality of Life, and Quantitative Health Outcomes in Women and Children: A Pilot Study
Many Americans are living paycheck to paycheck. This may lead to financial stress and an increase in overall stress. People under stress are more likely to smoke, consume alcohol, eat a poor diet, and experience depression or anxiety. Experiencing financial stress may also increase the risk for heart disease. The purpose of this research study is to test whether participating in the Financial Success Program improves health outcomes, in both the women participating and their children.
- Conditions
- Stress
- Keywords
- low socioeconomic status, stress, women, children, cortisol
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes of Exercise Per Week
Mean minutes of exercise per week
Measured: 1 year
Secondary outcomes (1)
Fast Food Meals Per Week
Mean number of fast food meals per week
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Packard, PharmD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409291
- Sponsor's protocol ID
- 11-16171
- Status last verified
- Aug 2014
- First submitted
- 29 Jul 2011
- Last updated
- 26 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Packard KA, Kalkowski J, White N, Ryan-Haddad A, Black L, Flecky K, Furze J, Rusch L, Qi Y. Chapter 5: Impact of a financial education program in single, low-income women and their children. In: Public Health: Improving Health via Inter-Professional Collaborations Ed: Rosemary M. Caron and Joav Merrick. 2014.
White N, Packard KA, Kalkowski J, Ryan-Haddad A, Flecky K, Furze J, Rusch L, Black L. Chapter 6: A novel financial education program in single women of low-income and their children In: Public Health: Improving Health via Inter-Professional Collaborations Ed: Rosemary M. Caron and Joav Merrick. 2014.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Financial Success Education Program on Perceived Financial Well-being, Hopefulness, Financial Competency, Financial Goal Achievement, Quality of Life, and Quantitative Health Outcomes in Women and Children: A Pilot Study
- ClinicalTrials.gov ID
- NCT01409291
- Acronym / sponsor ID
- 11-16171
- Conditions
- Stress
- Keywords
- low socioeconomic status, stress, women, children, cortisol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Posted 26 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many Americans are living paycheck to paycheck. This may lead to financial stress and an increase in overall stress. People under stress are more likely to smoke, consume alcohol, eat a poor diet, and experience depression or anxiety. Experiencing financial stress may also increase the risk for heart disease. The purpose of this research study is to test whether participating in the Financial Success Program improves health outcomes, in both the women participating and their children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women enrolled in the Financial Success Program and their children
Key inclusion criteria (3 listed)
- Women 19 years or older enrolled in the Financial Success Program in fall 2011 and winter 2012 and/or a their child(ren) ages 3-18 years attending the daycare with their mother
- Women must be employed to be enrolled in the Financial Success Program
- Able and willing to provide informed consent
Key exclusion criteria (4 listed)
- Women less than 19 years of age
- Women working a night time shift (due to variability in diurnal cortisol secretion)
- Known pregnancy or planned pregnancy (due to variability in blood pressure, glucose, weight, and lipids)
- Women are excluded from the Financial Success Program if they are living in a domestic violence situation or abusing alcohol or illicit drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Minutes of Exercise Per Week
Time frame: 1 year
Mean minutes of exercise per week
1 secondary outcome
Fast Food Meals Per Week
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationPackard KA, Kalkowski J, White N, Ryan-Haddad A, Black L, Flecky K, Furze J, Rusch L, Qi Y. Chapter 5: Impact of a financial education program in single, low-income women and their children. In: Public Health: Improving Health via Inter-Professional Collaborations Ed: Rosemary M. Caron and Joav Merrick. 2014.
- Results publicationWhite N, Packard KA, Kalkowski J, Ryan-Haddad A, Flecky K, Furze J, Rusch L, Black L. Chapter 6: A novel financial education program in single women of low-income and their children In: Public Health: Improving Health via Inter-Professional Collaborations Ed: Rosemary M. Caron and Joav Merrick. 2014.
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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
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 4 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 26 Aug 2014. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Minutes of Exercise Per Week (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01409291, which also lists 2 linked publications.
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 26 Aug 2014.