Food Interventions for Food Insecurity During Pregnancy

(ADAPT-MCH Trial)

Overseen By Rebecca Stone, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Severe cognitive, major psychiatric, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist pregnant individuals facing food insecurity, which can lead to health issues like gestational diabetes and pre-term birth. Researchers are testing various methods of providing food support, including medically tailored meals (customized meal plans designed to meet specific medical and nutritional needs) and produce prescriptions (vouchers or prescriptions for fresh fruits and vegetables), to determine the most effective approach. Participants will either receive a referral to a local Women, Infants, and Children (WIC) program or additional guidance from a care navigator to help overcome barriers to accessing WIC. Ideal participants are in their first trimester, experiencing food insecurity, and not currently enrolled in WIC. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for food insecurity during pregnancy.

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 meals tailored for medical needs are generally easy for people to handle. One study found that these meals can reduce hospital visits and healthcare costs, indicating their safety. Similarly, providing fresh fruits and vegetables as part of a "produce prescription" offers a promising way to improve diet during pregnancy. Studies suggest this can help control weight gain and may prevent complications. No major safety issues have been reported with these approaches. Both emphasize better nutrition, which is crucial for a healthy pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for addressing food insecurity during pregnancy because they aim to seamlessly integrate healthcare and community services, providing a holistic approach not typically offered by standard care. The use of electronic health record (EHR) referrals to the Women, Infants, and Children (WIC) program allows for streamlined and efficient communication between healthcare providers and community services. Additionally, the involvement of a patient care navigator to identify and overcome barriers to accessing WIC is a novel approach, offering personalized support that addresses social and structural challenges. This method not only leverages existing community resources but also enhances the support system for pregnant individuals facing food insecurity.

What evidence suggests that this trial's treatments could be effective for food insecurity during pregnancy?

This trial will evaluate two approaches to addressing food insecurity during pregnancy. One approach involves providing medically tailored meals. Studies have shown that these meals can improve health for pregnant individuals lacking sufficient food. Designed to meet nutritional needs, they can lower the risk of issues like gestational diabetes and low birthweights. The trial also explores the use of produce prescriptions, which research indicates can enhance diet and reduce health risks during pregnancy. Both efforts aim to combat food insecurity by supplying essential nutrients, potentially leading to better health outcomes for both mother and baby. ^{1 2 3 4 5}

Who Is on the Research Team?

Deepak Palakshappa, MD, MSHP

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for pregnant individuals experiencing food insecurity. It aims to improve their health and that of their children by providing support with nutrition. The study will test if giving out produce prescriptions or medically tailored meals can help. Specific eligibility details are not provided, but typically participants must meet certain health criteria.

Inclusion Criteria

Experience Food Insecurity (FI) based on the 2-item Hunger Vital Sign

Confirmed viable pregnancy by their obstetrician or midwife based on urine pregnancy test and ultrasound

Not currently enrolled in WIC

Exclusion Criteria

Planning on moving out of the area within 6 months

Severe cognitive impairment or major psychiatric illness that prevents consent or serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)

Severe food allergy or require a specialized diet (e.g., Celiac)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adaptive interventions to address food insecurity, including EHR referral to WIC and care navigation

6 months

Initial enrollment visit, follow-up at 2 weeks, and as necessary

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of food insecurity, gestational diabetes, and other health outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Medically tailored meals
• Produce prescription

Trial Overview The trial is testing the feasibility of adaptively allocating two types of interventions: produce prescriptions, which provide fresh fruits and vegetables, and medically tailored meals designed for specific health needs during pregnancy. The goal is to see if these can reduce food insecurity and improve maternal-child health outcomes.

How Is the Trial Designed?

Group I: Electronic Health Record (EHR) referral to Women, Infants and Children (WIC) + care navigation Experimental Treatment 2 Interventions

Participants will receive the same intervention as the electronic WIC referral. In addition, a patient care navigator will meet with the participant at enrollment to discuss any anticipated barriers to accessing WIC. The purpose of the visit is to build rapport and trust and to identify any social and structural barriers to enrolling in WIC. The navigator will also contact participants at 2 weeks to discuss any additional barriers reported and as necessary after the baseline visit. Specific counseling will be tailored based on individual's needs, for example difficulty with paperwork. The navigator will also assess any additional community resources to assist the participant with FI (e.g., local food pantries).

Group II: Electronic Health Record (EHR) referral to Women, Infants and Children (WIC) Active Control 2 Interventions

Participants randomized to this intervention will be referred to their county WIC program through an already developed electronic referral process. To enable WIC offices to receive referrals and easily communicate with healthcare teams, our EHR also offers a community provider-facing, read-only EHR version. We have already successfully provided WIC staff with access and training for our ongoing WIC screening and referral pilot in pediatrics

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a pilot study involving 172 participants from food-insecure areas, a collaborative food prescription program led to a remarkable 94.1% decrease in food insecurity, highlighting its effectiveness in improving access to nutritious food.

Participants received an average of 29.2 pounds of fresh produce and reported high satisfaction with the program, indicating strong community support and the potential for positive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot food prescription program promotes produce intake and decreases food insecurity. Aiyer, JN., Raber, M., Bello, RS., et al.[2020]

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]

Citations

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

Improving Maternal Health and Birth Outcomes Through ... During pregnancy, food insecurity can increase maternal stress, depression, and anxiety as well as preterm labor and low birthweights. Notably, ...

2. networkforphl.org networkforphl.org/news-insights/food-insecurity-and-pregnancy-addressing-inequities-through-food-is-medicine-initiatives/

Food Insecurity and Pregnancy: Addressing Inequities ... Food insecurity while pregnant can lead to short and long term health consequences, such as mental health conditions and disordered eating.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06965530

Study Details | NCT06965530 | Nourishing Tomorrow: Role ... The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes Through Clinic-Community Partnerships. Conditions.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2212267224000820

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 ...

5. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.01307

Estimated Impact Of Medically Tailored Meals On ... This study investigated the one-year and five-year effects of implementing MTMs in US states on hospitalizations, health care expenditures, and net costs.