PregnantNCT05725746
Feasibility of Remote Data Collection With a Point of Care Device to Measure HbA1c
An observational study of Pregnant and Postpartum, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Conduct a pilot study to test feasibility of doing remote data collection with a point of care device that measures HbA1c. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant, Postpartum
- What is being tested?
- Point of care device to measure HbA1c
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2023to 25 Apr 2024
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant or postpartum women who are currently or have recently participated in the Parents as Teachers home visiting program.
Who may be able to join
- English speaking
- Screened or participating in NCT04253977
- Able to give informed consent for participation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63130
About this study
Official title: Enhancing Cardiovascular Health Equity in Mothers and Children Through Home Visiting
Conduct a pilot study to test feasibility of doing remote data collection with a point of care device that measures HbA1c.
Read the 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.
- Conditions
- Pregnant, Postpartum
- Being tested
- Point of care device to measure HbA1c
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care device to measure HbA1cDiagnostic test
Also called A1C Now self check
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to Obtain HbA1c Through Remote Data Collection
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start24 Feb 2023
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
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.
- Other trials for PregnantStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debra Haire-Joshu, PhD, Principal investigator, Washington University School of MedicineVictor G Davila-Roman, MD,FACC,FASE, Principal investigator, Washington University School of MedicineRachel G Tabak, PhD, RD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725746
- Sponsor's protocol ID
- 202212059
- Status last verified
- Jul 2025
- First submitted
- 1 Feb 2023
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cardiovascular Health Equity in Mothers and Children Through Home Visiting
- ClinicalTrials.gov ID
- NCT05725746
- Acronym / sponsor ID
- 202212059
- Conditions
- Pregnant, Postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conduct a pilot study to test feasibility of doing remote data collection with a point of care device that measures 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant or postpartum women who are currently or have recently participated in the Parents as Teachers home visiting program.
Key inclusion criteria (3 listed)
- English speaking
- Screened or participating in NCT04253977
- Able to give informed consent for participation
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Point of care device to measure HbA1cAlso: A1C Now self checkAfter 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. 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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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.
Debra Haire-Joshu, PhD principal investigator
Washington University School of Medicine
Victor G Davila-Roman, MD,FACC,FASE principal investigator
Washington University School of Medicine
Rachel G Tabak, PhD, RD principal investigator
Washington University School of Medicine
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 Pregnant and Postpartum, run by Washington University School of Medicine 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 1 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 15 Jul 2025. 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 15 Jul 2025). 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?
Feasibility to Obtain HbA1c Through Remote Data Collection (time frame: Baseline). 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 15 Jul 2025.