Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

Not Applicable

Active, not recruiting

• Conditions: Cardiovascular Diseases; Obesity, Maternal; Diabetes
• Interventions: Behavioral: RDN Referral; Behavioral: WIC Referral

• Registration Number: NCT06311799
• Lead Sponsor: Geisinger Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Study Start: 2024-04-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3: Clinic-RDN Model	RDN Referral	Clinical team gives WIC information only; connects patient to registered dietitian/nutritionist (RDN)
Arm 4: Clinic-WIC-RDN	RDN Referral	Clinical team connects patient to WIC and RDN
Arm 2: Clinic-WIC Model	WIC Referral	Clinical team connects patient to WIC
Arm 4: Clinic-WIC-RDN	WIC Referral	Clinical team connects patient to WIC and RDN

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Geisinger Health System; 🇺🇸 Danville, Pennsylvania, United States