The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05725746
Recruitment Status : **RECRUITING NOW**
First Posted : February 13, 2023
Last Update Posted : February 27, 2023
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
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Brief Summary:
Conduct a pilot study to test feasibility of doing remote data collection with a point of care device that measures HbA1c.
Pregnant Postpartum
Diagnostic Test: Point of care device to measure HbA1c
Detailed Description:
The foundation for cardiovascular health (CVH) is laid in early life by intergenerational interactions, passed from parent to child, that have long-lasting biological and behavioral consequences. Lifestyle interventions can promote CVH among mothers and their children over time. Academic partnerships with home visiting organizations that reach families experiencing health disparities advance intergenerational CVH equity. For this pilot study we are testing the feasibility of doing remote data collection with a point of care device that measures HbA1c to use in the main study.
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Study Type :
Observational
Estimated Enrollment :
15 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Enhancing Cardiovascular Health Equity in Mothers and Children Through Home Visiting
Estimated Study Start Date :
February 24, 2023
Estimated Primary Completion Date :
June 12, 2023
Estimated Study Completion Date :
June 12, 2023
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Intervention Details:
Diagnostic Test: Point of care device to measure HbA1c
After consent the participant will meet with the research team virtually to obtain HbA1c. The HbA1c self check equipment will be sent to the participant. During the video call the research team will talk the participant through obtaining their HbA1c with the point of care device.
Other Name: A1C Now self check
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Primary Outcome Measures :
Feasibility to obtain HbA1c through remote data collection [ Time Frame: Baseline ]
Feasibility will be measured by how many participants are able to obtain HbA1c measure through remote data collection and participant’s satisfaction with this means of data collection.
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
Female
Gender Based Eligibility: Â
Yes
Gender Eligibility Description: Â
For the participants only women will be included: Including only female participants is scientifically justified, as the main study focus is addressing cardiovascular health of prenatal and postpartum women.
Accepts Healthy Volunteers: Â
Yes
Sampling Method: Â
Non-Probability Sample
Pregnant or postpartum women who are currently or have recently participated in the Parents as Teachers home visiting program.
Inclusion Criteria:
English speaking
Screened or participating in NCT04253977
Able to give informed consent for participation
Exclusion Criteria:
–
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05725746
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Washington University in St. Louis
Saint Louis, Missouri, United States, 63130
Contact: Rachel Tabak, PhD, RD   314-935-0153   rtabak@wustl.edu  Â
Contact: Cindy Schwarz, MPH,MS,RD   3149353063   cschwarz@wustl.edu  Â
Washington University School of Medicine
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Principal Investigator:
Debra Haire-Joshu, PhD
Washington University School of Medicine
Principal Investigator:
Victor G Davila-Roman, MD,FACC,FASE
Washington University School of Medicine
Principal Investigator:
Rachel G Tabak, PhD, RD
Washington University School of Medicine
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Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05725746 Â Â
Other Study ID Numbers:
202212059
First Posted:
February 13, 2023 Â Â Key Record Dates
Last Update Posted:
February 27, 2023
Last Verified:
February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Undecided
Plan Description:
Only data with identifiers removed will be shared publicly. Any identified data to be shared will only be done so in coordination with the Human Research Protection Office at Washington University in St. Louis and the Institutional Review Board (IRB) at the requesting investigator’s institution.
Datasets with identifiers will only be accessible to study team members with appropriate Human Subjects training.
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
