Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

Diabetes Clinical Trial

— FIMPreg  

Official title:

Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311799
• Other study ID #: 2024-0102
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Geisinger Clinic
• Contact: Shawnee L Lutcher, MHA
• Phone: 5702141424
• Email: sllutcher1[@]geisinger.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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 and a dietitian will talk to them about heart-healthy diets and food management. This study will last about 18 months and will have 200 total subjects joining at about 50 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 team after they are done.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 within 1 of our 7 targeted counties

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes

Intervention

Behavioral:
• WIC Referral
Clinical team will refer study participants to WIC
• RDN Referral
Clinical team will refer study participants to a RDN

Locations

Country	Name	City	State
United States	Geisinger Health System	Danville	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Geisinger Clinic	American Heart Association, Family Health Council of Central Pennsylvania (FHCCP)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	WIC retention	Number of WIC benefit pick up visits completed	6 months
Secondary	WIC adherence	Frequency of redeeming WIC benefit	6 months
Secondary	Prenatal clinic visit adherence.	Number of prenatal clinic visits attended	6 months
Secondary	Registered Dietitian/Nutritionist (RDN) visit adherence	Number of RDN visits completed	6 months