Food Program for Pregnancy Complications

Overseen By Michelle Axe, MS, CHES

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Christiana Care Health Services

Disqualifiers: Diabetes, Multiple pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies (from enrollment to 4 weeks postpartum)

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called the Women's Health Delaware Food Farmacy to determine its effectiveness in helping pregnant patients at risk for complications. Participants will receive medically tailored groceries delivered to their homes and support from a community health worker, while others will continue with the usual standard of care. Researchers aim to discover if this program improves health outcomes for mothers and babies. This trial suits pregnant women who are ChristianaCare patients, have a BMI of 30 or higher, are on Medicaid, and live in New Castle County. As an unphased trial, it offers participants the chance to contribute to innovative healthcare solutions that could significantly enhance maternal and infant health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Women's Health Delaware Food Farmacy is safe for pregnant patients?

Research shows that the Women's Health Delaware Food Farmacy program helps pregnant women by providing healthy groceries and support from a community health worker. While specific safety data isn't mentioned, programs of this nature typically aim to improve diet and offer social support, which are generally safe and well-received.

As this is a pilot study without new medications or medical procedures, the risks are likely low. The program emphasizes good nutrition and community support, which are crucial for maintaining health during pregnancy. Participants may find the program beneficial, as it aims to enhance the health of both mothers and their babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Women's Health Delaware Food Farmacy because it offers a fresh approach to managing pregnancy complications. Unlike the usual standard of care, which typically involves medical monitoring and standard nutritional advice, this program provides medically tailored groceries rich in micronutrients, directly addressing dietary needs. Additionally, participants receive personalized support from Community Health Workers, who help tackle social needs and set patient-centered goals. This holistic method not only delivers essential nutrients but also empowers expectant mothers by addressing broader health determinants, potentially improving outcomes for both mothers and their babies.

What evidence suggests that the Women's Health Delaware Food Farmacy could be effective for pregnancy complications?

This trial will compare the Women's Health Delaware Food Farmacy with the usual standard of care. Research has shown that the Women's Health Delaware Food Farmacy could improve pregnancy outcomes. Studies indicate that a lack of nutritious food during pregnancy can lead to issues like gestational diabetes and high blood pressure. Programs like Food is Medicine aim to prevent these problems by providing healthy meals. Past programs have demonstrated that addressing dietary needs can enhance the health of mothers and their babies. Focusing on personalized nutrition might positively impact the health of both mothers and children. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for pregnant women receiving care at ChristianaCare who are at risk of complications like high blood pressure, gestational diabetes, eclampsia, pre-eclampsia, or obesity. Specific eligibility details aren't provided but typically include factors like age and health status.

Inclusion Criteria

ChristianaCare Women's Health patient

I am between 1 and 3 months pregnant.

Singleton pregnancy

Exclusion Criteria

Diagnosed with severe medical comorbidities that might interfere with their ability to participate in the intervention, such as severe psychiatric illness or imminent hospitalization

I have been diagnosed with diabetes.

Multiple pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive medically tailored groceries and interact weekly with a Community Health Worker from enrollment to 4 weeks after delivery

Varies (from enrollment to 4 weeks postpartum)

Weekly interactions (in-person or virtual)

Follow-up

Participants are monitored for maternal and child health outcomes, healthcare utilization, and clinical event outcomes

Up to 90 days postpartum

Postpartum assessments

What Are the Treatments Tested in This Trial?

Interventions

• Usual Standard of Care
• Women's Health Delaware Food Farmacy

Trial Overview The study is testing a 'Food is Medicine' program by Women's Health Delaware Food Farmacy against the standard healthcare pregnant women usually receive. It aims to see if this program can improve maternal and child health outcomes.

How Is the Trial Designed?

Group I: Women's Health Delaware Food Farmacy Experimental Treatment 1 Intervention

Participants will receive medically tailored groceries (10 meals per person in the household per week from enrollment to 4 weeks after delivery) high in micronutrients that are delivered to their homes weekly. They will also interact weekly with their assigned Community Health Worker to address social needs and patient-centered goals.

Group II: Usual Standard of Care Active Control 1 Intervention

Participants will receive the usual standard of care.

Who Is Running the Clinical Trial?

Christiana Care Health Services

Lead Sponsor

Trials

118

Recruited

204,000+

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

Published Research Related to This Trial

A healthy diet for pregnant women should focus on nutrient-dense whole foods like fruits, vegetables, and healthy fats, rather than increasing food quantity, to reduce the risk of complications and improve birth outcomes.

Women with 'prudent' eating patterns before and during pregnancy experience fewer complications, and comprehensive nutritional supplementation can lead to better birth outcomes, highlighting the importance of early dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of nutrition in pregnancy and lactation: lifelong consequences. Marshall, NE., Abrams, B., Barbour, LA., et al.[2023]

Participation in the WIC program during pregnancy led to increased intake of key nutrients like protein, iron, calcium, and vitamin C, which are essential for maternal and infant health.

The program was associated with improved pregnancy outcomes, such as reversal of low weight gain in early pregnancy and larger infant head circumference, although it did not significantly affect birth weight or breastfeeding rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The National WIC Evaluation: evaluation of the Special Supplemental Food Program for Women, Infants, and Children. V. Longitudinal study of pregnant women. Rush, D., Sloan, NL., Leighton, J., et al.[2018]

Obese women (BMI ≥ 30) face a significantly higher risk of infertility and pregnancy complications, including hypertensive disorders and gestational diabetes, compared to normal-weight women.

The risk of having a child with neural tube defects is approximately doubled in obese women, and this risk is not reduced by folic acid supplementation, highlighting the importance of weight management before and during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teratology Public Affairs Committee position paper: maternal obesity and pregnancy. Scialli, AR.[2006]

Participation in the Women, Infants and Children Food Supplement Program is associated with a lower incidence of low birth weight infants (10.2% for participants vs. 13.1% for nonparticipants), suggesting potential benefits of the program for maternal and infant health.

While program participants showed a reduced risk for low birth weight deliveries (odds ratio = 0.75), this association was influenced by other factors such as race, prenatal care entry, and smoking habits, indicating that these variables may confound the relationship between program participation and birth outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of the Women, Infants and Children Food Supplement Program on birth outcome. Brown, HL., Watkins, K., Hiett, AK.[2022]

Women who participated in a prenatal health education program, including nutrition counseling and smoking cessation support, had a higher smoking cessation rate during pregnancy (49.1% vs. 37.5% in the control group) and a greater reduction in daily smoking rates.

Infants born to women in the experimental group had a higher average birth weight (121.34 oz vs. 113.64 oz) and fewer low birth weight cases (7.0% vs. 9.7%), leading to significant hospital cost savings and a benefit-cost ratio of approximately 2:1 for the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral, health, and cost outcomes of an HMO-based prenatal health education program. Ershoff, DH., Aaronson, NK., Danaher, BG., et al.[2019]

Women of childbearing age should focus on optimizing their health through proper weight management, physical activity, and a balanced diet to reduce risks of birth defects and promote healthy fetal development.

Pregnant women should follow specific guidelines for weight gain and energy needs, with recommendations of 340 kcal and 452 kcal extra per day during the second and third trimesters, respectively, while also considering vitamin and mineral supplementation in certain vulnerable situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice paper of the Academy of Nutrition and Dietetics abstract: nutrition and lifestyle for a healthy pregnancy outcome. Kaiser, LL., Campbell, CG.[2019]

Limited evidence suggests that infants who are never fed human milk may have a higher risk of developing celiac disease, while the relationship between the duration of human milk feeding and celiac disease remains unclear due to potential reverse causality.

For inflammatory bowel disease (IBD), there is consistent but limited evidence indicating that shorter durations of any human milk feeding are associated with a higher risk of IBD, although the overall evidence is inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant milk-feeding practices and diagnosed celiac disease and inflammatory bowel disease in offspring: a systematic review. Güngör, D., Nadaud, P., Dreibelbis, C., et al.[2023]

Many women reduce their fish consumption during pregnancy despite receiving information about healthy fish options, indicating that simply providing information may not be enough to change behavior.

Messages highlighting the specific health benefits of fish for babies were particularly effective, suggesting that targeted communication strategies could encourage higher fish consumption among pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How can more women of childbearing age be encouraged to follow fish consumption recommendations? Connelly, NA., Lauber, TB., Niederdeppe, J., et al.[2014]

A pilot program in Wisconsin aimed at pregnant women provided information about safe fish consumption and the risks of methylmercury, but only 13% of surveyed women recalled seeing the outreach materials.

Despite the program, women reported consuming an average of 3 fish meals per month, with many unaware of the specific risks associated with older and predatory fish, highlighting a gap in effective communication and awareness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fish consumption and advisory awareness among expectant women. Gliori, G., Imm, P., Anderson, HA., et al.[2006]

In a five-year study involving 239 women, the incidence of low birth weight (LBW) was significantly lower (8.3%) among participants receiving enhanced social and psychological support compared to a control group (21.9%), highlighting the importance of support during pregnancy.

Participants showed better compliance (91% vs. 70%) with vitamin/mineral supplements, which were crucial for addressing nutrient deficiencies in their diets, suggesting that support can lead to improved health behaviors and outcomes for both mothers and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple factors as mediators of the reduced incidence of low birth weight in an urban clinic population. Edwards, CH., Knight, EM., Johnson, AA., et al.[2022]

A significant majority of Dutch obstetric caregivers, including 80.2% of midwives and 93.9% of obstetricians, view a strict plant-based diet as a potential risk factor for nutrient deficiencies during pregnancy, highlighting concerns about maternal and fetal health.

Despite these concerns, many caregivers reported a lack of knowledge about how to manage a strict plant-based diet, with 66.1% of midwives and 75.4% of obstetricians feeling unprepared to provide adequate advice, suggesting a need for better education and guidelines in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care by Midwives, Obstetricians, and Dietitians for Pregnant Women Following a Strict Plant-Based Diet: A Cross-Sectional Study. Meulenbroeks, D., Versmissen, I., Prins, N., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06180811

NCT06180811 | Evaluating the Effectiveness of a Food is ... Aim 3: To evaluate the effectiveness of the Women's Health Delaware Food Farmacy on maternal and child health, healthcare utilization, and clinical event ...

2. jandonline.org jandonline.org/article/S2212-2672(24)00082-0/fulltext

Implementation and Impact of Perinatal Food Is Medicine ... Nutrition insecurity during this time can lead to poor maternal outcomes, including gestational diabetes; anemia; and preeclampsia (ie, pregnancy-induced high ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10681943/

Opportunities for Examining Child Health Impacts of Early-Life ... This study aimed to describe dietary intake data available in the ECHO Program as of 31 August, 2022 (end of year 6 of Cycle 1) from pregnancy through ...

4. jandonline.org jandonline.org/article/S2212-2672(24)00082-0/pdf

Implementation and Impact of Perinatal Food Is Medicine ... Nutrition insecurity, especially during pregnancy and postpartum, can lead to poor maternal and birth outcomes. Food is Medicine (FIM) programs, which integrate ...

5. nap.nationalacademies.org nap.nationalacademies.org/download/2022

Nutrition Services in Perinatal Care: Second Edition Nutrition clearly makes a difference to the health of women, to outcomes of pregnancy and lactation, and to the health, growth, and ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06180811/evaluating-the-effectiveness-of-a-food-is-medicine-community-health-worker-program-for-pregnant-women

Evaluating the Effectiveness of a Food is Medicine ... This study is a pilot randomized controlled trial where eligible pregnant ChristianaCare patients will be identified weekly through an automated ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/11/NCT06180811/SAP_000.pdf

Evaluating the Effectiveness of a Food is Medicine ... Statistical Analysis Plan. Aim 1: To assess the feasibility of the Women's Health Delaware Food Farmacy and refine the program as needed.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10926555/

Knowledge and practice of community pharmacists regarding ... This study aimed to explore the knowledge and practices of CPs regarding medications and herb safety during pregnancy.

9. fda.gov fda.gov/media/124746/download

Postapproval Pregnancy Safety Studies Guidance for ... For questions regarding this draft document, contact (CDER) Denise Johnson-Lyles at 301-796-. 6169 or (CBER) the Office of Communication, ...

10. christianacare.org christianacare.org/us/en/visit-us/for-patients/your-patient-privacy.html

Your Patient Privacy Call ChristianaCare's Privacy and Compliance Hotline at 302-623-4468 to report a privacy concern or ask a question about completing Privacy forms.