Nutritional Support for Pregnant Individuals Facing Food Insecurity

Recruiting in Cleveland (>99 mi)

+1 other 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

Trial Summary

What is the purpose of this trial?

This trial is testing if community health workers can help pregnant women on Medicaid get and eat healthy food. Some participants will have food delivered to them, while others will receive support to buy healthy food. The goal is to see if this support improves their diet and 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 data supports the effectiveness of the treatment Nutritional Support for Pregnant Individuals Facing Food Insecurity?

Research shows that food provision interventions, like food vouchers and food pharmacies, can improve nutritional health outcomes for at-risk patients, suggesting similar benefits for pregnant individuals facing food insecurity. ^{1 2 3 4 5}

Is nutritional support safe for pregnant individuals facing food insecurity?

The research does not provide specific safety data for nutritional support interventions like food vouchers or cash assistance for pregnant individuals, but these types of support generally aim to improve access to healthy food, which is considered safe and beneficial for overall health. ^{6 7 8 9 10}

How does the treatment 'Financial Support, Food Delivery' differ from other treatments for food insecurity in pregnant individuals?

This treatment is unique because it combines financial support and direct food delivery to address food insecurity, rather than relying solely on traditional food banks or charitable food assistance, which often have limited capacity to meet the needs of pregnant individuals facing severe poverty. ^{4 11 12 13 14}

Research Team

Elaine A Borawski, PhD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 (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]

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]

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 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]

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 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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Feasibility and Pilot Study of a Personalized Nutrition Intervention in Mobile Food Pantry Users in Northeastern Connecticut. [2021]

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

Implementing a Process for Screening Hospitalized Adults for Food Insecurity at a Tertiary Care Center. [2023]

3. United States 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. [2023]

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

Healthcare-based interventions to address food insecurity during pregnancy: a systematic review. [2023]

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

Development of a Medically Tailored Hospital-based Food Pantry System. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Dietary risk of donated food at an Australian food bank: an audit protocol. [2023]

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

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

8. England pubmed.ncbi.nlm.nih.gov

Nudging while online grocery shopping: A randomized feasibility trial to enhance nutrition in individuals with food insecurity. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

An evaluation of SecondBite® 's FoodMate® , a nutrition education and skill-building program aimed at reducing food insecurity. [2021]

10. United States 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. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Household food insecurity and hunger among families using food banks. [2022]

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

Experiences of Food-Insecure Pregnant Women and Factors Influencing Their Food Choices. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence of Food Insecurity Among Pregnant Women: A Canadian Study in a Large Urban Setting. [2021]

14. England 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. [2022]