Nutritional Support for Pregnant Individuals Facing Food Insecurity

Recruiting at 1 trial location

Overseen By Samantha Bentley, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Case Western Reserve University

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

Compensation: Varies

Number of Visits: Unknown

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if community health workers can assist pregnant individuals facing food insecurity in accessing nutritious food. Participants will receive either bi-weekly food deliveries or a $30 gift card, along with assistance in locating nearby food markets. The trial seeks to identify which approach better supports healthy eating during pregnancy. It is ideal for those on Medicaid who are part of the Community Health Worker Hub and can read and understand English. As an unphased trial, it offers participants the chance to contribute to important research that could improve community health support systems.

Will I have to stop taking my current medications?

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

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

Research has shown that providing food or financial help is generally safe for pregnant individuals who lack adequate nutrition. Studies indicate that food assistance can lower the risk of pregnancy issues such as gestational diabetes, high blood pressure, and early birth. It also helps reduce stress and unhealthy eating habits, which are common when food is scarce during pregnancy.

Evidence suggests that cash support can lead to better pregnancy outcomes. For instance, programs providing money to pregnant individuals have been linked to fewer early births and healthier birth weights.

Overall, these types of support aim to improve nutrition and financial stability, proving safe and beneficial for pregnant individuals. No specific reports of negative side effects from these forms of assistance exist. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial exploring financial support and food delivery for pregnant individuals facing food insecurity because these approaches address fundamental needs that go beyond traditional medical treatments. Unlike standard care, which might focus on nutritional supplements or counseling services, these treatments directly provide resources like bi-weekly food boxes and financial aid with guidance on accessing local food markets. This method could significantly improve maternal and infant health by ensuring consistent access to nutritious food, ultimately reducing stress and enhancing overall well-being during pregnancy and postpartum.

What evidence suggests that this trial's treatments could be effective for improving nutritious food access for pregnant individuals facing food insecurity?

Research has shown that providing food delivery, one of the treatment arms in this trial, to pregnant individuals experiencing food insecurity can improve health outcomes. Studies indicate that food assistance lowers risks such as gestational diabetes and anemia, ensuring healthier pregnancies. One study found that food delivery programs increase access to nutritious foods, benefiting both mother and baby.

Financial support and guidance, offered in another arm of this trial, also play a crucial role in enhancing health outcomes for pregnant individuals. Evidence suggests that cash or voucher programs enable the purchase of healthy foods and improve overall food security. Additionally, social assistance programs have been linked to better birth outcomes, supporting the health of both mother and child. Both approaches significantly aid those facing food insecurity during pregnancy. ^{6 7 8 9 10}

Who Is on the Research Team?

Elaine A Borawski, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who are experiencing food insecurity, are eligible for Medicaid, and can read and understand English. They must enroll in the Community Health Worker (CHW) Hub to participate.

Inclusion Criteria

Medicaid eligible

Enrolls in the CHW Hub

Able to read and understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either direct food delivery or financial support and navigation for accessing local healthy foods

Until 6 weeks post delivery

Bi-weekly interactions

Follow-up

Participants are monitored for dietary behavior, psychosocial health, health care utilization, and health outcomes

6 weeks post delivery

What Are the Treatments Tested in This Trial?

Interventions

• Financial Support
• Food Delivery

Trial Overview

The study tests a program where community health workers help improve access to nutritious food through direct food delivery and financial support. It's done with the Greater Cleveland Food Bank and Better Health Partnership CHW HUB.

How Is the Trial Designed?

Group I: Food Delivery Experimental Treatment 1 Intervention

Food box delivered to participant home every 2 weeks until 6 weeks post delivery

Group II: Financial Support and Navigation Experimental Treatment 1 Intervention

$30 provide on gift card every two weeks until 6 weeks post delivery + neighborhood food retail navigation support.

Group III: Control Group Active Control 1 Intervention

Selected from claims data, matched.

Financial Support is already approved in United States for the following indications:

Approved in United States as Financial Support for Food Access for:

• Food Insecurity During Pregnancy

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

MetroHealth Medical Center

Collaborator

Trials

125

Recruited

22,600+

Pregnancy with Possibilities Resource Center

Collaborator

Trials

1

Recruited

120+

Better Health Partnership

Collaborator

Trials

1

Recruited

120+

Greater Cleveland Food Bank

Collaborator

Trials

1

Recruited

120+

Village of Healing Center

Collaborator

Trials

1

Recruited

120+

United Way of Greater Cleveland

Collaborator

Trials

1

Recruited

120+

Mom's First - Cleveland Department of Public Health

Collaborator

Trials

1

Recruited

120+

Cleveland Department of Public Health

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

A study involving 50 participants with food insecurity showed that using a prefilled, nutritionally balanced online grocery shopping cart led to significantly healthier purchases compared to just reviewing nutrition information.

Participants using the default shopping cart bought more whole grains, fruits, and vegetables, while also selecting foods lower in sodium, cholesterol, and unhealthy fats, indicating that this approach can effectively promote better nutrition in financially constrained individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging while online grocery shopping: A randomized feasibility trial to enhance nutrition in individuals with food insecurity. Coffino, JA., Udo, T., Hormes, JM.[2021]

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]

Over half of the food pantry clients studied (50.5%) experienced very low food security, which was linked to lower consumption of fruits, vegetables, and fiber, indicating a significant impact on diet quality.

Despite a mean BMI of 29.5 kg/m² and women being four times more likely to be obese than men, food insecurity did not show a direct association with obesity in this group, suggesting other factors may influence weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food insecurity, poor diet quality, and obesity among food pantry participants in Hartford, CT. Robaina, KA., Martin, KS.[2022]

A study of 153 women using food banks in Metropolitan Toronto revealed that 90% had household incomes below two-thirds of the poverty line, indicating severe economic hardship.

Despite relying on food banks, 70% of participants experienced absolute food deprivation, highlighting the inadequacy of charitable food assistance programs to fully address food insecurity in the context of chronic poverty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Household food insecurity and hunger among families using food banks. Tarasuk, VS., Beaton, GH.[2022]

Prenatal care clinics have a significant opportunity to address food insecurity among pregnant individuals, but most lack specific protocols for screening and intervention, which limits their effectiveness.

Key barriers include insufficient dedicated staff and community resources, while supportive clinic cultures and trusting patient-clinician relationships can facilitate better screening and intervention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Missed opportunities to improve food security for pregnant people: a qualitative study of prenatal care settings in Northern New England during the COVID-19 pandemic. Canavan, CR., D'cruze, T., Kennedy, MA., et al.[2022]

Food insecurity during pregnancy significantly impacts women's ability to access nutritious food, leading to reliance on cheaper, less healthy options despite their awareness of the importance of good nutrition for maternal and fetal health.

The study highlights the urgent need for supportive strategies in antenatal healthcare to address the challenges faced by food-insecure pregnant women, especially in the context of the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Food-Insecure Pregnant Women and Factors Influencing Their Food Choices. Zinga, J., McKay, FH., Lindberg, R., et al.[2022]

In a study of 626 pregnant women receiving prenatal care in Toronto, the overall prevalence of food insecurity was found to be 12.8%, with significantly higher rates (21.3%) at a site serving a more disadvantaged population compared to 4.4% at another site.

Key factors associated with food insecurity included being from a non-White ethnicity and having a household income below CAD $23,000 per year, suggesting that targeted interventions for low-income and non-White pregnant women could help address this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Food Insecurity Among Pregnant Women: A Canadian Study in a Large Urban Setting. Shirreff, L., Zhang, D., DeSouza, L., et al.[2021]

A new method was developed to assess the dietary risk of donated food at an Australian food bank, focusing on nutrition quality and food safety, using a detailed audit of 86,050 kg of food over five days.

The audit revealed that 1,500 images were needed to evaluate the food donations, highlighting the importance of transparency and accountability from food donors, especially given the lack of regulations for food donations in the charitable food system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary risk of donated food at an Australian food bank: an audit protocol. Mossenson, S., Giglia, R., Pulker, CE., et al.[2023]

The FoodMate® program, an 8-week nutrition education initiative, was well-received by participants and led to long-term improvements in their cooking skills, dietary habits, and overall life satisfaction over a follow-up period of up to 2 years.

Participants reported enhanced confidence in cooking and trying new foods, indicating that such programs can effectively promote healthy eating and food independence among individuals facing food insecurity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of SecondBite® 's FoodMate® , a nutrition education and skill-building program aimed at reducing food insecurity. Stephens, LD., Smith, G., Olstad, DL., et al.[2021]

A newly developed questionnaire, validated through expert review and pilot testing, effectively measures maternal food insecurity and its potential link to fetal structural anomalies.

The final version of the questionnaire demonstrated strong content validity and reliability, making it a suitable tool for future research in this important public health area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development and Validation of a Questionnaire to Investigate the Association Between Maternal Food Insecurity and Fetal Structural Anomalies: Delphi Procedure and Pilot Study. Zaçe, D., Hoxhaj, I., Pasciuto, T., et al.[2023]

A new screening process for food insecurity was successfully implemented in a hospital setting, increasing the screening rate from just 2.2% to 61.5% over 28 weeks, demonstrating the effectiveness of integrating a validated screening tool into the nursing workflow.

Out of the patients screened, 5.8% were identified as food insecure, highlighting the importance of such screenings in connecting vulnerable patients with necessary food resources, even amidst challenges like staff turnover and the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a Process for Screening Hospitalized Adults for Food Insecurity at a Tertiary Care Center. Gore, E., DiTursi, J., Rambuss, R., et al.[2023]

A systematic review of 10 studies on food provision programs for patients with type 2 diabetes or prediabetes showed that those including nutrition education consistently reduced HbA1c levels, indicating improved diabetes management.

Programs varied widely in their design and implementation, but those that incorporated nutrition education—covering topics like general nutrition and fruit/vegetable consumption—tended to yield better dietary quality and health outcomes compared to those without such education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. Schier, HE., Chetty, KS., Garrity, K., et al.[2023]

Over half (56%) of high-needs cancer patients in New York City face food insecurity, often having to choose between medical treatment and food.

The FOOD intervention has successfully set up 11 medically tailored food pantries in NYC cancer centers, providing over 307,000 meals since 2011 to help alleviate this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Medically Tailored Hospital-based Food Pantry System. Gany, FM., Pan, S., Ramirez, J., et al.[2023]

The 8-week personalized nutrition intervention for mobile food pantry users resulted in a significant average weight loss of 2.3% among participants, indicating its effectiveness in promoting weight management.

While the treatment group showed a greater improvement in diet quality compared to the control group, this change was not statistically significant, suggesting that while the intervention is promising, further research is needed to confirm its impact on dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility and Pilot Study of a Personalized Nutrition Intervention in Mobile Food Pantry Users in Northeastern Connecticut. Marmash, D., Ha, K., Sakaki, JR., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8643580/

Social Assistance Programs and Birth Outcomes

Social assistance programs that provide cash or in-kind transfers, such as food or vouchers, hold potential to improve birth outcomes.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2161831325001681

Healthy Food Voucher Programs: Global Evidence on ...

Most evidence indicates that HFVPs increase the purchase and consumption of healthy foods, improve food security, and enhance nutrition ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11505288/

Exploring the associations of food and financial insecurity ...

We found a lower level of breastfeeding among mothers experiencing food insecurity and using food assistance. Resources to support longer breastfeeding duration ...

4.

earlychildhood.stanford.edu

earlychildhood.stanford.edu/news/cash-payments-help-address-food-insecurity-families-rapid-study-finds-timing-and-amount-matter

Cash payments help address food insecurity in families ...

The outcome of the study suggests that lump sum payments may be better suited for addressing food insecurity during times of crisis, while ...

5.

cbpp.org

cbpp.org/research/food-assistance/wic-works-addressing-the-nutrition-and-health-needs-of-low-income-families

WIC Works: Addressing the Nutrition and Health Needs of ...

One study estimates that participation in WIC reduces the prevalence of food insecurity among children by at least 20 percent. In addition, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10938935/

Prescription for Cash? Cash Support to Low‐Income Families ...

Evidence increasingly suggests that income supports have an impact on pregnancy and child health outcomes. Comprehensive evidence from low‐ and ...

7.

cbpp.org

cbpp.org/research/income-security/economic-security-programs-should-support-pregnant-people-and-their

Economic Security Programs Should Support Pregnant ...

Lawmakers should meaningfully improve economic security programs that support pregnant people and their families without undermining their reproductive freedom.

8.

healthaffairs.org

healthaffairs.org/doi/full/10.1377/hlthaff.2024.01641

Expanded Child Tax Credit Payments During Pregnancy ...

For every $1,000 in ECTC payments received during pregnancy, we observed decreased odds of preterm birth, low birthweight, and very low ...

9.

povertycenter.columbia.edu

povertycenter.columbia.edu/sites/default/files/content/Publications/Cash-payments-during-pregnancy-CPSP-2023.pdf

Should Cash Payments Begin During Pregnancy?

This brief reviews the research on the potential impact of cash delivered during pregnancy on birth and longer-term outcomes. This research ...

10.

sciencedirect.com

sciencedirect.com/science/article/pii/S0022316622004436

Social Assistance Programs and Birth Outcomes

Social assistance programs that provide cash or in-kind transfers, such as food or vouchers, hold potential to improve birth outcomes.