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

Geisinger Health

Status: Completed

Conditions: Obesity, Maternal; Diabetes; Cardiovascular Diseases

Treatments: Behavioral: RDN Referral; Behavioral: WIC Referral

Study type: Interventional

Funder types: Other

Identifiers

NCT06311799

2024-0102

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 4 patient groups

Arm 1: Clinic Model

No Intervention group

Description:

Clinical team gives WIC information only

Arm 2: Clinic-WIC Model

Active Comparator group

Description:

Clinical team connects patient to WIC

Treatment:

Behavioral: WIC Referral

Arm 3: Clinic-RDN Model

Active Comparator group

Description:

Clinical team gives WIC information only; connects patient to registered dietitian/nutritionist (RDN)

Treatment:

Behavioral: RDN Referral

Arm 4: Clinic-WIC-RDN

Active Comparator group

Description:

Clinical team connects patient to WIC and RDN

Treatment:

Behavioral: WIC Referral

Behavioral: RDN Referral