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

240 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment RDN Referral, WIC Referral for maternal health?

Research shows that registered dietitian nutritionists (RDNs) can help improve patient recovery and reduce hospital readmissions by providing nutrition care, and WIC referrals can connect women to important health and welfare services, which may support maternal health. ^{1 2 3 4 5}

How does the WIC + RDN Referrals treatment differ from other treatments for maternal health?

The WIC + RDN Referrals treatment is unique because it combines nutrition education and supplemental food with referrals to health and welfare services, addressing both nutritional and broader health needs of low-income pregnant and postpartum women. This approach not only provides immediate nutritional support but also connects participants to additional resources like medical, dental, and social services, which is not typically part of standard maternal health treatments. ^{2 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Lisa Bailey-Davis, DEd

Principal Investigator

Geisinger Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Extending the Reach of Hospital-Based Nutrition: A Registered Dietitian Nutritionist's Perspective on the Malnutrition Quality Improvement Initiative and Improving Patient Recovery. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Referrals of participants in an urban WIC program to health and welfare services. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Assessing the influence of registered dietitian order-writing privileges on parenteral nutrition use. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Peer Counselor Support on Breastfeeding Outcomes in WIC-Enrolled Women. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Maternal, Infant, and Child Health Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants, and Children : A Systematic Review. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Recruitment and retention of WIC participants in a longitudinal dietary intervention trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Association of Revised WIC Food Package With Perinatal and Birth Outcomes: A Quasi-Experimental Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Insights in public health: The Special Supplemental Nutrition Program for Women, Infants and Children: strengthening families for 40 years. [2023]