Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health

Official title

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

Overview

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.

Detailed 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.

Interventions

• Behavioral Produce prescription
  Participants randomized to this arm will receive $10 worth of produce delivered to their home weekly. Participants will receive a weekly delivery of produce for 3 months.
• Behavioral Medically tailored meals
  Medically tailored meals will be delivered weekly to participant's homes for 3 months. During the 3 months, participants will receive 10 medically-tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly. All meals are planned by a registered dietician. Meals have minimal preparation time, can be heated by stove, oven, or microwave, and will be provided free-of-charge. Because the meals are medically tailored, participants are asked not to share them. Adhere
• Behavioral Electronic health record WIC referral
  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.
• Behavioral Electronic health record WIC referral + care navigation
  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 coun

Primary outcome measures

• Feasibility of recruitment - Proportion of eligible patients who enroll [Time frame: Baseline]
• Feasibility of retention - Proportion of eligible participants [Time frame: Month 6]
• Feasibility of re-randomization - Proportion of eligible participants [Time frame: Month 3]
• Food insecurity Scores [Time frame: Month 6]

Secondary outcome measures (10)

• Incidence of Gestational diabetes [Time frame: Month 6]
• Gestational weight gain [Time frame: Post-delivery]
• Incidence of Pre-eclampsia [Time frame: Post-delivery]
• Number of Community resources uses [Time frame: month 6]
• Infant birth weight at the time of delivery [Time frame: Baseline]
• Infant gestational age at the time of delivery [Time frame: Baseline]
• Post delivery outcomes - Number of vaginal versus c-section Deliveries [Time frame: Baseline]
• Post delivery outcomes - infant APGARS Scores [Time frame: Baseline]
• Post delivery outcomes - breastfeeding status [Time frame: Baseline]
• Number of Glucose homeostasis episodes [Time frame: Baseline and month 6]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 1 center

• Wake Forest University Health Sciences — Winston-Salem

Publications

• Palakshappa D, Stone RJ, Ramirez B, White SE, Rigdon J, Bundy R, Eagleton SG, Caudill N, Martin H, Grundseth M, Best S, Mongraw-Chaffin M, Lewis KH, Montez K. Feasibility of an ADAPTive intervention to improve food security and Maternal-Child Health (ADAPT-MCH): Protocol for a pilot sequential multiple assignment randomized trial. Contemp Clin Trials. 2025 Nov;158:108086. doi: 10.1016/j.cct.2025.1 PMID 40975433

Identifiers

NCT: NCT06942598 · IRB00116098 · 1R01DK141526-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗