WIC + RDN Referrals for Maternal Health

(FIMPreg Trial)

Overseen By Shawnee L Lutcher, MHA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Geisinger Clinic

Disqualifiers: Pre-existing WIC, Private insurance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if online referrals to the Women, Infants, and Children (WIC) program by clinical teams can increase enrollment among pregnant women. The study recruits pregnant women receiving healthcare at Geisinger who have public insurance or no insurance and meet WIC income requirements. Participants are divided into four groups: some receive typical WIC information, while others receive referrals and guidance from registered dietitian nutritionists (RDNs) on heart-healthy diets. The trial lasts about six months per participant, during which they complete surveys about their experiences. As an unphased trial, this study offers participants the chance to contribute to research that could enhance WIC enrollment processes and support for pregnant women.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on WIC referrals and dietitian consultations, so it's unlikely that medication changes are required.

What prior data suggests that these referral methods are safe for maternal health?

Research has shown that referrals to the Women, Infants, and Children (WIC) program are safe and effective. Studies have found that WIC successfully improves nutrition, helping pregnant women have longer pregnancies and fewer premature births, which are positive indicators of safety.

For referrals to a registered dietitian/nutritionist (RDN), studies strongly support their safety and benefits. Seeing an RDN can help manage weight gain during pregnancy, which is important for both the mother and baby. No reported increases in complications have been found for mothers who receive this support.

Overall, both WIC and RDN referrals are considered safe and helpful, focusing on improving maternal health without added risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring new ways to improve maternal health through enhanced support systems. Unlike traditional care, which often includes basic nutritional advice, this trial investigates the impact of direct referrals to WIC (Women, Infants, and Children) services and registered dietitians/nutritionists (RDNs). By connecting patients directly to these resources, the trial aims to assess if this more integrated approach can provide better nutritional guidance and support, potentially leading to improved health outcomes for mothers and their babies.

What evidence suggests that this trial's treatments could be effective for increasing WIC enrollment?

Research has shown that joining the Women, Infants, and Children (WIC) program can lead to healthier births and lower infant death rates. WIC is a successful and cost-effective program that improves the nutrition and health of mothers and children. Studies indicate that mothers in WIC often experience healthier pregnancies and have healthier babies. In this trial, some participants will receive WIC information or be connected to WIC services.

Strong evidence suggests that seeing a registered dietitian nutritionist (RDN) can help manage weight gain during pregnancy. While this might not reduce pregnancy complications, it remains important for a healthy pregnancy. In this trial, some participants will be connected to an RDN. Both WIC and RDN support can play a crucial role in improving the health of pregnant women and their children. ^{1 2 4 6 7}

Who Is on the Research Team?

Lisa Bailey-Davis, DEd

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

This trial is for English-speaking pregnant women with public insurance or no insurance, planning to deliver at a Geisinger facility in one of seven targeted counties. They must be willing to consent and participate for up to 12 months. Women already enrolled in WIC as pregnant persons or those with private insurance cannot join.

Inclusion Criteria

Intent to deliver at a Geisinger facility within 1 of our 7 targeted counties

Confirmed pregnancy

English speaking

Exclusion Criteria

Not eligible for WIC

Pre-existing WIC enrollment as a pregnant person

Unwilling to participate for up to 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Intervention

Participants are enrolled and assigned to one of four groups to receive WIC information and/or referrals, with some receiving additional dietitian consultations

6 months

Initial visit for enrollment and assignment

Follow-up

Participants are monitored for WIC enrollment, RDN visit adherence, and prenatal clinic visit adherence

6 months

Surveys at start and end, additional feedback collection

What Are the Treatments Tested in This Trial?

Interventions

• RDN Referral
• WIC Referral

Trial Overview The study tests if online referrals by clinical teams increase enrollment in the WIC program. It involves four groups: usual care, direct referral to WIC, usual care plus dietitian advice on heart-healthy diets, and direct referral plus dietitian advice. Participants will complete surveys at the beginning and end of their six-month involvement.

How Is the Trial Designed?

Group I: Arm 1: Clinic Model Active Control 1 Intervention

Clinical team gives WIC information only

Group II: Arm 2: Clinic-WIC Model Active Control 1 Intervention

Clinical team connects patient to WIC

Group III: Arm 3: Clinic-RDN Model Active Control 1 Intervention

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

Group IV: Arm 4: Clinic-WIC-RDN Active Control 2 Interventions

Clinical team connects patient to WIC and RDN

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Family Health Council of Central Pennsylvania (FHCCP)

Collaborator

Trials

1

Recruited

240+

Published Research Related to This Trial

Registered dietitians (RDs) with order writing privileges can significantly improve patient outcomes, such as nutrition status and glycemic control, by ensuring timely implementation of nutrition interventions, as demonstrated in a successful program at a large medical center.

The implementation of an RD order writing program requires careful consideration of regulations, training, and ongoing monitoring, but it ultimately leads to better management of patient care and cost savings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient outcomes through registered dietitian order writing. Roberts, SR.[2013]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32037271/

Maternal and Infant Health Outcomes Associated with ... There was good/strong evidence that MNT by an RDN decreased gestational weight gain, although there was no effect on maternal complications.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212267219315837

Maternal and Infant Health Outcomes Associated with ... There was good/strong evidence that MNT by an RDN decreased gestational weight gain, although there was no effect on maternal complications, caesarean section ...

3. jandonline.org jandonline.org/article/S2212-2672(14)00501-2/fulltext

Nutrition and Lifestyle for a Healthy Pregnancy Outcome Components leading to a healthy pregnancy outcome include healthy prepregnancy weight, appropriate weight gain and physical activity during pregnancy, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9492153/

Optimizing Maternal Nutrition: The Importance of a Tailored ... Personalized nutrition offers women the opportunity to improve their health by using strategies that are tailored to their unique nutritional needs.

5. researchgate.net researchgate.net/publication/339094172_Maternal_and_Infant_Health_Outcomes_Associated_with_Medical_Nutrition_Therapy_by_Registered_Dietitian_Nutritionists_in_Pregnant_Women_with_Malnutrition_An_Evidence_Analysis_Center_Systematic_Review

Maternal and Infant Health Outcomes Associated with ... There was good/strong evidence that MNT by an RDN decreased gestational weight gain, although there was no effect on maternal complications, caesarean section ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11622467/

Comparing models that integrate obstetric care and WIC on ... Low-income, rural pregnant women are at disproportionate risk for adverse pregnancy outcomes as well as future cardiovascular risk.

7. dcjournal.ca dcjournal.ca/doi/10.3148/cjdpr-2023-014

Does Dietitian Involvement During Pregnancy Improve ... The objective of this systematic review was to determine if RD involvement during pregnancy is associated with a lower prevalence of adverse birth outcomes.