Nutrition Support for Pregnant Women

Recruiting at 1 trial location

Overseen By Stephen Roll, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Male, Non-pregnant, Over 24 weeks, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Approximately 9-12 months

750 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called FreshRx Nourishing Healthy Starts, which provides food and nutrition support to pregnant women facing food insecurity. It aims to determine if supplying fresh meal kits and nutrition education can improve the health of both mothers and their babies. Additionally, the trial examines whether adding social worker support for issues like housing and social services offers further benefits. Women who are less than 24 weeks pregnant, on Medicaid, and live in specific Missouri zip codes may qualify if they have difficulty accessing enough nutritious food. As an unphased trial, participants contribute to groundbreaking research that may 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. It is best to consult with the trial coordinators or your healthcare provider for guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the FreshRx Nourishing Healthy Starts program improves the health of pregnant women by offering food and nutrition support. Studies have found that this program, which includes delivering fresh produce and providing cooking tips, reduces food insecurity and boosts maternal health.

No specific safety concerns or negative effects have been reported with the program. Since it focuses on nutrition by providing food and education, it is generally well-tolerated. Programs like this are usually safe because they offer healthy foods and support instead of medications or medical procedures.

Additionally, the program includes guidance from registered dietitians, ensuring that the nutritional support is safe and suitable for pregnant women. While detailed data on negative effects is lacking, the nature of the program suggests it is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a comprehensive, holistic approach to supporting pregnant women, which goes beyond standard nutritional programs like SNAP and WIC. Treatment 1: Nutrition Services provides weekly deliveries of fresh food meal kits with step-by-step recipes, along with necessary cooking tools and online resources to enhance culinary skills. Meanwhile, Treatment 2: Integrated Care Services builds on this by adding the support of a Licensed Masters Social Worker, who helps address broader life challenges such as housing stability and access to social services. This integrative approach aims to address both nutritional and social needs, potentially leading to healthier starts for both mothers and their babies.

What evidence suggests that this trial's treatments could be effective for improving health and birth outcomes for food insecure pregnant women?

Research has shown that the FreshRx Nourishing Healthy Starts program can improve the health of pregnant women and their babies. In this trial, participants in the "Treatment 1: Nutrition Services" arm will receive weekly meal kits and nutrition counseling. Studies have found these interventions can reduce food insecurity and lower stress, depression, and anxiety in mothers. Participants in the "Treatment 2: Integrated Care Services" arm will receive these benefits along with trauma-informed integrative care services. Evidence suggests these programs can also lower the risk of early labor and low birth weight in newborns. By addressing both nutrition and social needs, this program aims to provide mothers and their children with a healthier start. ^{1 3 4 6 7}

Who Is on the Research Team?

Stephen Roll, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 14-55, less than 24 weeks gestation, living in specific Missouri zip codes. They must be experiencing food insecurity, speak English, and receive care through a Missouri Medicaid managed care organization.

Inclusion Criteria

Missouri resident residing in the following zip codes: 63031, 63033, 63042, 63074, 63114, 63121, 63130, 63132, 63133, 63135, 63136, 63137, 63138, 63140

You are currently pregnant.

Less than 24 weeks gestation

Exclusion Criteria

I am male.

I am younger than 14 or older than 55.

Non-pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive weekly food deliveries, nutrition education, and integrative care services from enrollment through 60 days post-partum

Approximately 9-12 months

Weekly interactions (virtual or in-person)

Follow-up

Participants are monitored for health outcomes and program efficacy through surveys and health claims data

1 year post-partum

Quarterly data collection

Post-partum Monitoring

Monitoring of maternal and infant health outcomes, including emergency room visits and postpartum complications

60 days post-partum

What Are the Treatments Tested in This Trial?

Interventions

• FreshRx Nourishing Healthy Starts

Trial Overview The study tests the Fresh Rx: Nourishing Healthy Starts program which provides food support and integrative care services to improve health outcomes for mothers and babies against standard prenatal care.

How Is the Trial Designed?

Group I: Treatment 2: Integrated Care Services Experimental Treatment 1 Intervention

This treatment group will receive all the services offered to Treatment Group 1, as well as the services of a Licensed Masters Social Worker who will provide trauma-informed integrative care services to participants. These services will focus on an array of potential needs that may emerge in participants' lives, such as assistance in finding stable housing, assistance navigating social services, connections with other community organizations, and other needs.

Group II: Treatment 1: Nutrition Services Experimental Treatment 1 Intervention

This treatment group will receive all the services offered to the control group, as well as the following services: Weekly food deliveries of fresh food meal kits with step-by-step recipes from the time of program enrollment through 60 days post-partum. Access to necessary cooking tools for their kitchen (e.g., spatulas, cutting boards , etc.), should they need them. Access to online cooking resources to help guide them on culinary skills and recipe preparation. Nutrition education and counseling provided by a registered dietitian.

Group III: Enhanced Usual Care Active Control 1 Intervention

The control group in this study will still receive some services above and beyond the usual standard of care offered to pregnant women on Medicaid. In addition to the case management services offered through their managed care provider, Operation Food Search will offer this group access to the "hunger hotline," a service provided by Operation Food Search to help them find food assistance around St. Louis; assistance in enrolling in public nutrition assistance programs like SNAP and WIC; and guidance on food pantry access in St. Louis.

FreshRx Nourishing Healthy Starts is already approved in United States for the following indications:

Approved in United States as Fresh Rx: Nourishing Healthy Starts for:

• Food insecurity during pregnancy
• Improvement of maternal health outcomes
• Improvement of birth and infant health outcomes

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Operation Food Search Inc.

Collaborator

Trials

1

Recruited

750+

Published Research Related to This Trial

A citizens' jury involving 8 first-time pregnant women evaluated a modified healthy eating booklet and deemed it a suitable resource for providing dietary advice during pregnancy.

The study highlighted the importance of including end-users' perspectives in developing health resources, ensuring that the content is relevant, comprehensible, and credible for pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a citizens' jury approach to determine a good nutrition resource for pregnant women. Coppell, KJ., Paterson, H., Norton, J., et al.[2023]

Stakeholder satisfaction with the Prince Edward Island prenatal program is high among nutritionists, health professionals, and clients, indicating that the program is generally effective in providing nutrition support to at-risk pregnant women.

Key strengths of the program include its counselling approach and accessibility, while areas for improvement involve staffing, communication, and administrative processes, highlighting the importance of the staff-client relationship in program success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder evaluation of a high-risk prenatal nutrition intervention program in Prince Edward Island. MacLellan, D., Bradley, D., Brimacombe, M.[2015]

A survey of 100 pregnant women revealed that 90% had not seen a Registered Dietitian (RD) during their pregnancy, yet 48% expressed a desire for access to dietetic services, highlighting a gap in prenatal nutrition support.

Registered Dietitians reported facing challenges in providing effective prenatal nutrition counseling, indicating a need for improved access and integration of dietetic services in prenatal care systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal Nutrition Care in Alberta: The Perspectives of Pregnant Women and Registered Dietitians. Misita, D., Aulakh, S., Jain, V., et al.[2023]

The Prenatal Nutrition Tool was developed through a systematic 9-step process that included literature review and expert opinions, ensuring it is based on solid research and expert consensus.

This tool, which includes a questionnaire and conversation guide, aims to facilitate discussions on key nutrition topics for pregnant clients, ultimately supporting better maternal and infant health outcomes without replacing comprehensive nutritional assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Prenatal Nutrition Tool: A Process of Evidence, Collaboration, and Consultation. Cross, A., Galesloot, S., Tyminski, S., et al.[2022]

Healthcare-based interventions addressing food insecurity during pregnancy, such as food vouchers and nutrition education, were associated with improved food security levels and reduced odds of preterm birth, based on a systematic review of 5 studies.

The interventions showed a program utilization rate of 56% to 81%, indicating that they were well-received by participants, although the overall quality of the studies was moderate to low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare-based interventions to address food insecurity during pregnancy: a systematic review. Merchant, T., Soyemi, E., Roytman, MV., et al.[2023]

Pregnant women in the UK expressed a strong desire for practical support services that help them establish healthy eating habits early in their pregnancy, emphasizing the importance of routine formation.

Participants preferred these services to be led by women with pregnancy experience and suggested marketing through midwives and online platforms to enhance accessibility and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting healthy eating in pregnancy: what kind of support services do women say they want? Olander, EK., Atkinson, L., Edmunds, JK., et al.[2016]

The survey conducted at the Bradford Women's and Newborn unit revealed that maternity care providers offer a diverse range of nutritional information to pregnant women, which is crucial given the risks associated with obesity during pregnancy.

Healthcare managers are actively working to improve training for care providers and are developing a dedicated service to better support obese women, highlighting a commitment to enhancing maternal and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition advice in pregnancy. Farrar, D., Butterfield, G., Palethorpe, R., et al.[2015]

This study highlights the important role of registered dietitians (RDs) in high-risk obstetrics (HRO) inpatient teams, where they primarily provide nutrition education, screen for nutritional risks, and manage vitamin and mineral orders.

Despite the recognized importance of nutrition in managing high-risk pregnancy conditions, the specific contributions of RDs are not well-defined, indicating a need for further research to clarify their impact and develop best practice guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the nutrition professional in high-risk obstetrics inpatient teams. Gurau, J., Cronk, A., Pelliccia, M., et al.[2015]

The Nourishing Beginnings program aims to improve food security and health outcomes for Medicaid-eligible pregnant individuals by providing either bi-weekly home food deliveries or financial assistance for healthy food access, supported by community health workers.

The study involves 160 pregnant individuals and assesses various outcomes, including prenatal care and psychosocial factors, over multiple time points to evaluate the effectiveness of the interventions in enhancing maternal and infant health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study design and protocol for Nourishing Beginnings, an integrated service delivery model addressing food insecurity and social needs of low-income pregnant individuals. Borawski, EA., Goodwin, MA., Glenn, AC., et al.[2023]

A survey of 195 Australian dietitian nutritionists revealed that only 17% correctly identified 'Imbalance of nutrients' as a diagnostic code for refeeding syndrome, indicating a significant gap in understanding standardized nutrition terminology.

The study highlighted that 86% of respondents incorrectly selected multiple diagnostic codes, suggesting a lack of clarity in the application of the Nutrition Care Process (NCP) and Nutrition Care Process Terminology (NCPT), which may hinder effective nutrition care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The accuracy and consistency of nutrition care process terminology use in cases of refeeding syndrome. Matthews, KL., Palmer, MA., Capra, SM.[2019]

A study involving 115 medical doctors in Greece revealed that 65.2% had inadequate knowledge of clinical nutrition (CN), which is crucial for providing effective nutritional support in hospitals.

Many doctors overestimated their CN expertise, with only 56.5% accurately assessing their knowledge; participation in continuous medical education significantly improved their understanding, highlighting the need for enhanced training in CN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is continuing medical education sufficient? Assessing the clinical nutrition knowledge of medical doctors. Grammatikopoulou, MG., Katsouda, A., Lekka, K., et al.[2020]

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]

Dietary counseling, with or without oral nutrition supplementation, does not significantly reduce 30-day mortality in hospitalized malnourished adults but may slightly reduce 6-month mortality and complications, based on a meta-analysis of 16 studies.

The evidence suggests that dietary counseling can improve nutrition status and may reduce hospital readmission rates, although the certainty of these findings varies and further research is needed to standardize counseling methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of dietary counseling with or without nutrition supplementation in hospitalized patients who are malnourished or at risk of malnutrition: A systematic review and meta-analysis. Wong, A., Huang, Y., Sowa, PM., et al.[2022]

Outcomes research is crucial for advancing the specialty practice of nutrition support by identifying effective and ineffective practices.

The manuscript emphasizes the need for research that evaluates the real-world effectiveness of nutrition support interventions to improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes research in specialized nutrition support. August, DA., Serrano, D.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38670549/

Improving Maternal Health and Birth Outcomes Through ... This study examines a food-is-medicine approach that aimed to reduce food insecurity, maternal stress, depression, anxiety, preterm labor, and low birthweight.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11568643/

Improving Maternal Health and Birth Outcomes Through ... FreshRx is a food-is-medicine program providing weekly meal kits, nutrition support, and counseling to reduce food insecurity, maternal stress, ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/22799036221102496

Does a food insecurity intervention improve perinatal ... The Fresh Rx: Nourishing Healthy Starts study uses a randomized design to examine a comprehensive, holistic “food is medicine” program targeting food insecure ...

4. csd.wustl.edu csd.wustl.edu/items/nourishing-healthy-starts/

Nourishing Healthy Starts The goal of the program is to provide food and nutrition support during pregnancy to improve maternal health and birth outcomes. It is anticipated that a ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/08901171241249278

Improving Maternal Health and Birth Outcomes Through ... This study examines a food-is-medicine approach that aimed to reduce food insecurity, maternal stress, depression, anxiety, preterm labor, and low birthweight.

6. operationfoodsearch.org operationfoodsearch.org/fresh-rx-nourishing-healthy-starts/

Nourishing Healthy Starts The Nourishing Healthy Starts program provides pregnant women, all birthing people and their families with weekly fresh produce and grocery boxes, cooking ...

7. researchgate.net researchgate.net/publication/380150255_Improving_Maternal_Health_and_Birth_Outcomes_Through_FreshRx_A_Food-Is-Medicine_Intervention

Improving Maternal Health and Birth Outcomes Through ... This study examines a food-is-medicine approach that aimed to reduce food insecurity, maternal stress, depression, anxiety, preterm labor, and low birthweight.