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

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 Medically tailored meals and Produce prescription for addressing food insecurity during pregnancy?

A pilot study on a home-delivery produce prescription program showed that participants experienced reduced food hardship and improved access to food, although fruit and vegetable intake remained below recommended levels. This suggests that produce prescriptions can help improve food security and nutrition, but more research is needed to confirm their effectiveness. ^{1 2 3 4 5}

Is it safe to participate in food interventions for food insecurity during pregnancy?

The research does not provide specific safety data for food interventions like medically tailored meals or produce prescriptions during pregnancy, but these interventions generally involve providing healthy foods, which are typically safe for most people. ^{1 2 6 7 8}

How do medically tailored meals and produce prescriptions differ from other treatments for food insecurity during pregnancy?

Medically tailored meals and produce prescriptions are unique because they directly provide nutritious food to pregnant individuals, addressing food insecurity by ensuring access to healthy meals and fresh produce. Unlike other interventions that may focus on financial assistance or education alone, this approach combines direct food provision with nutritional support, potentially improving diet quality and reducing food insecurity more effectively. ^{1 3 5 7 9}

What is the purpose of this trial?

Food insecurity affects up to 30% of pregnancies and leads to worse health in pregnant people and their children, including an increased risk of gestational diabetes, pre-term birth, and future cardiometabolic chronic conditions (e.g., type 2 diabetes and obesity). Interventions are being utilized to address food insecurity in clinical care settings, but patients differ in the support needed to reduce food insecurity and health systems have limited resources to invest in these interventions. Rather than a single intervention, adaptively allocating interventions could be a more effective, equitable, and efficient approach to improve food security; the objectives of this pilot study are to determine the feasibility of recruiting, retaining, and adaptively providing food insecurity interventions to pregnant patients in anticipation of a large, definitive trial in the future.

Research Team

Deepak Palakshappa, MD, MSHP

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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)

Planning on moving out of the area within 6 months

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Household food insecurity is associated with obesogenic health behaviours among a low-income cohort of pregnant women in Boston, MA. [2023]

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

Household Food Insecurity Is Not Associated with Overall Diet Quality Among Pregnant Women in NHANES 1999-2008. [2018]

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

Validation of a 2-Item Food Insecurity Screen Among Adult General Medicine Outpatients. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Home-Delivery Produce Prescription Program to Address Food Insecurity and Diet Quality in Adults and Children. [2023]

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

Feeding a family in a recession: food insecurity among Minnesota parents. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Additional Fruit and Vegetable Vouchers for Pregnant WIC Clients: An Equity-Focused Strategy to Improve Food Security and Diet Quality. [2023]

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

Food Insecurity and Cardiovascular Health in Pregnant Women: Results From the Food for Families Program, Chelsea, Massachusetts, 2013-2015. [2019]

9. England pubmed.ncbi.nlm.nih.gov

A pilot food prescription program promotes produce intake and decreases food insecurity. [2020]