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

Trial Summary

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 data supports the effectiveness of the treatment Usual Standard of Care, Women's Health Delaware Food Farmacy for pregnancy complications?

Research shows that a healthy diet during pregnancy, which includes a variety of nutrient-rich foods like fruits, vegetables, and whole grains, can lead to fewer pregnancy complications and better birth outcomes. Programs that provide nutritional support and education, similar to the Women's Health Delaware Food Farmacy, have been associated with higher birth weights and reduced rates of low birth weight infants. ^{1 2 3 4 5}

Is the Food Program for Pregnancy Complications safe for humans?

The research highlights the importance of a balanced diet during pregnancy, emphasizing nutrient-dense foods like fruits, vegetables, and whole grains, which are generally safe and beneficial. However, specific safety data for the Food Program for Pregnancy Complications under its various names is not directly addressed in the provided studies. ^{1 6 7 8 9}

How does the Women's Health Delaware Food Farmacy treatment differ from other treatments for pregnancy complications?

The Women's Health Delaware Food Farmacy treatment is unique because it focuses on providing nutrient-dense, whole foods to improve pregnancy outcomes, unlike standard treatments that may not emphasize dietary changes. This approach is similar to the WIC program, which has shown benefits like increased intake of essential nutrients and improved birth outcomes. ^{1 2 6 10 11}

What is the purpose of this trial?

The purpose of this study is to conduct a pilot randomized controlled trial of a food is medicine community health worker intervention called the Women's Health Delaware Food Farmacy compared to the usual standard of care among pregnant ChristianaCare patients at risk for adverse clinical outcomes. The pilot study has three specific aims: Aim 1: To assess the feasibility of the Women's Health Delaware Food Farmacy and refine the program as needed Aim 2: To determine the prevalence of and change in social needs Aim 3: To evaluate the effectiveness of the Women's Health Delaware Food Farmacy on maternal and child health, healthcare utilization, and clinical event outcomes as well as patient-reported outcomes compared to the usual standard of care

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

The importance of nutrition in pregnancy and lactation: lifelong consequences. [2023]

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

The impact of the Women, Infants and Children Food Supplement Program on birth outcome. [2022]

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

Behavioral, health, and cost outcomes of an HMO-based prenatal health education program. [2019]

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

Multiple factors as mediators of the reduced incidence of low birth weight in an urban clinic population. [2022]

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

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

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

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

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

How can more women of childbearing age be encouraged to follow fish consumption recommendations? [2014]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Care by Midwives, Obstetricians, and Dietitians for Pregnant Women Following a Strict Plant-Based Diet: A Cross-Sectional Study. [2021]

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

Fish consumption and advisory awareness among expectant women. [2006]

10. United States 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. [2018]

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

Infant milk-feeding practices and diagnosed celiac disease and inflammatory bowel disease in offspring: a systematic review. [2023]