Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy (FIMPreg)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Diabetes; Obesity, Maternal
• Intervention / Treatment: Behavioral: WIC Referral; Behavioral: RDN Referral

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1: Clinic Model; Clinical team gives WIC information only
Active Comparator: Arm 2: Clinic-WIC Model; Clinical team connects patient to WIC	Behavioral: WIC Referral; Clinical team will refer study participants to WIC
Active Comparator: Arm 3: Clinic-RDN Model; Clinical team gives WIC information only; connects patient to registered dietitian/nutritionist (RDN)	Behavioral: RDN Referral; Clinical team will refer study participants to a RDN
Active Comparator: Arm 4: Clinic-WIC-RDN; Clinical team connects patient to WIC and RDN	Behavioral: WIC Referral; Clinical team will refer study participants to WIC; Behavioral: RDN Referral; Clinical team will refer study participants to a RDN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Women, Infants, and Children (WIC) enrollment	Difference in WIC enrollment between Arm 1 and Arm 3 (Information only) vs Arm 2 and Arm 4 (digital connections)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WIC retention	Number of WIC benefit pick up visits completed	6 months
WIC adherence	Frequency of redeeming WIC benefit	6 months
Prenatal clinic visit adherence.	Number of prenatal clinic visits attended	6 months
Registered Dietitian/Nutritionist (RDN) visit adherence	Number of RDN visits completed	6 months

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: American Heart Association; Family Health Council of Central Pennsylvania (FHCCP)
• Investigators: Principal Investigator: Lisa D Bailey-Davis, Geisinger Clinic

Publications and helpful links

General Publications

• Herb Neff KM, Brandt K, Chang AR, Lutcher S, Mackeen AD, Marshall KA, Naylor A, Seiler CJ, Wood GC, Wright L, Bailey-Davis L. Comparing models that integrate obstetric care and WIC on improved program enrollment during pregnancy: a protocol for a randomized controlled trial. BMC Public Health. 2024 Dec 5;24(1):3393. doi: 10.1186/s12889-024-20509-6.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Nutrition Disorders; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Overnutrition; Body Weight; Pregnancy Complications; Glucose Metabolism Disorders; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Cardiovascular Diseases; Diabetes Mellitus; Pregnancy in Obesity
• Other Study ID Numbers: 2024-0102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data collected during the trial will be shared, after de-identification.
• IPD Sharing Time Frame: Data will be made available immediately following publication. No end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data may access for any purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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