Skip to content

Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06311799
Acronym
FIMPreg
Enrollment
240
Registered
2024-03-15
Start date
2024-04-29
Completion date
2025-12-31
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Diabetes, Obesity, Maternal

Brief summary

This study is being done to find out if online referrals to a food management program for Women, Infants, and Children (WIC) made by clinical teams will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and are eligible to be referred to the WIC program will be recruited. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their clinical team. Group 2 will be sent to WIC by their clinical team. The study team may help the clinical team with the referrals. Group 3 will get details about WIC from their clinical team and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their clinical team or study team and a dietitian will talk to them about heart-healthy diets and food management. Participants who talk with the dietitians will be sent kitchen utensils based on need. This study will last about 18 months and will have 240 total subjects joining at about 60 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study after they are done.

Interventions

BEHAVIORALWIC Referral

Clinical team will refer study participants to WIC

BEHAVIORALRDN Referral

Clinical team will refer study participants to a RDN

Sponsors

Family Health Council of Central Pennsylvania (FHCCP)
CollaboratorUNKNOWN
American Heart Association
CollaboratorOTHER
Geisinger Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* English speaking * Confirmed pregnancy * Public Insurance (Medicaid) OR no insurance * If no insurance, must meet income eligibility for WIC * Intent to deliver at a Geisinger facility * Able and willing to provide consent

Exclusion criteria

* Pre-existing WIC enrollment as a pregnant person * Not eligible for WIC * Private insurance * Unwilling to participate for up to 12 months

Design outcomes

Primary

MeasureTime frameDescription
Difference in Women, Infants, and Children (WIC) enrollment6 monthsDifference in WIC enrollment between Arm 1 and Arm 3 (Information only) vs Arm 2 and Arm 4 (digital connections)

Secondary

MeasureTime frameDescription
WIC retention6 monthsNumber of WIC benefit pick up visits completed
WIC adherence6 monthsFrequency of redeeming WIC benefit
Prenatal clinic visit adherence.6 monthsNumber of prenatal clinic visits attended
Registered Dietitian/Nutritionist (RDN) visit adherence6 monthsNumber of RDN visits completed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 28, 2026