Feasibility of Remote Data Collection With a Point of Care Device to Measure HbA1c

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.

Study Overview

• Status: Completed
• Conditions: Pregnant; Postpartum
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant or postpartum women who are currently or have recently participated in the Parents as Teachers home visiting program.

Description

Inclusion Criteria:

• English speaking
• Screened or participating in NCT04253977
• Able to give informed consent for participation

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Debra Haire-Joshu, PhD, Washington University School of Medicine; Principal Investigator: Rachel G Tabak, PhD, RD, Washington University School of Medicine; Principal Investigator: Victor G Davila-Roman, MD,FACC,FASE, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 202212059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No