Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health (ADAPT-MCH)

Wake Forest University (WFU)

Status: Not yet enrolling

Conditions: Food Insecurity; Pregnancy

Treatments: Behavioral: Medically tailored meals; Behavioral: Produce prescription

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06942598

1R01DK141526-01 (U.S. NIH Grant/Contract)

IRB00116098

Details and patient eligibility

About

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.

Full description

The US is facing a maternal and infant health crisis. Each year in the US there are >700 maternal deaths and >60,000 life-threatening pregnancy events. Despite decreasing in other high-income countries, maternal mortality has increased in recent years in the US with a staggering 1210 maternal deaths in 2019. Importantly, maternal deaths in the US are now less likely to be due to direct complications of childbirth, and are increasingly due to endocrine (e.g. gestational diabetes (GDM)) or cardiovascular (e.g. pre-eclampsia) conditions directly related to obesity and other nutrition-related chronic diseases. One significant contributor to maternal mortality is food insecurity (FI), or the lack of consistent access to the food needed for a healthy life. In 2023, 13.5% of US households, (>40 million people), were food insecure. Households with young children have higher rates of FI. Also, up to 30% of pregnancies are impacted by FI. Pregnant and postpartum women are especially vulnerable to the impacts of FI as they have increased nutritional requirements for the growing fetus and while breastfeeding. FI has been associated with inadequate or excessive gestational weight gain, GDM, and pregnancy-induced hypertension. Excess retained weight after pregnancy has important health consequences including development of type 2 diabetes. GDM and gestational weight retention also confer higher risk of complications in subsequent pregnancies and future cardiovascular disease. Additionally, FI is associated with increased risk of preterm birth and infants being born low birth weight, affecting children's growth trajectories and future risk of developing obesity.

To address the high prevalence of FI and its impact on health, national healthcare organizations, including the Centers for Medicare and Medicaid (CMS) and The American College of Obstetricians and Gynecologists, have recommended that health systems address FI as a routine part of clinical care. The integration of interventions to address FI in different populations, particularly those with nutrition-related conditions, has been termed "Food is Medicine". CMS has been piloting Food is Medicine interventions as part of Medicaid reform in several states, including North Carolina. Three "Food is Medicine" interventions that are being studied and used by health systems and insurers include: 1) referring patients to government benefits intended to support nutrition or directly providing food through the use of 2) produce prescriptions and 3) medically-tailored meals. Despite the growing use of FI interventions in clinical care settings, a 2023 systematic review highlighted the need for more research on healthcare system-based interventions to reduce FI in pregnancy.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ≥18 years of age
• Confirmed viable pregnancy by their obstetrician or midwife based on urine pregnancy test and ultrasound
• Experience Food Insecurity (FI) based on the 2-item Hunger Vital Sign
• Speaks English or Spanish
• Not currently enrolled in WIC
• First trimester at the time of the initial prenatal visit

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)
• Lack safe, stable residence or the ability to store the medically tailored meals (MTM)
• Lack of a telephone
• Severe food allergy or require a specialized diet (e.g., Celiac)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Electronic Health Record (EHR) referral to Women, Infants and Children (WIC)

Active Comparator group

Description:

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

Treatment:

Behavioral: Produce prescription

Behavioral: Medically tailored meals

Electronic Health Record (EHR) referral to Women, Infants and Children (WIC) + care navigation

Experimental group

Description:

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).

Treatment:

Behavioral: Produce prescription

Behavioral: Medically tailored meals