Clinical trial NCT06942598: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Insecurity
Pregnancy
Keywords: Supplemental Nutrition Program for Women/Infants/Children
Medically tailored meals
Fruits and vegetables
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-04-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Electronic Health Record (EHR) referral to Women, Infants and Children (WIC) or EHR referral to WIC + care navigation
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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)

Primary outcomes:
measure: Feasibility of recruitment - Proportion of eligible patients who enroll
timeFrame: Baseline
measure: Feasibility of retention - Proportion of eligible participants
timeFrame: Month 6
measure: Feasibility of re-randomization - Proportion of eligible participants
timeFrame: Month 3
measure: Food insecurity Scores
timeFrame: Month 6
Secondary outcomes:
measure: Incidence of Gestational diabetes
timeFrame: Month 6
measure: Gestational weight gain
timeFrame: Post-delivery
measure: Incidence of Pre-eclampsia
timeFrame: Post-delivery
measure: Number of Community resources uses
timeFrame: month 6
measure: Infant birth weight at the time of delivery
timeFrame: Baseline
measure: Infant gestational age at the time of delivery
timeFrame: Baseline
measure: Post delivery outcomes - Number of vaginal versus c-section Deliveries
timeFrame: Baseline
measure: Post delivery outcomes - infant APGARS Scores
timeFrame: Baseline
measure: Post delivery outcomes - breastfeeding status
timeFrame: Baseline
measure: Number of Glucose homeostasis episodes
timeFrame: Baseline and month 6
Other outcomes:
measure: Food expenditures
timeFrame: Month 6
measure: Fruit and vegetable intake
timeFrame: Month 6
measure: Depressive symptoms Scores
timeFrame: Month 6
measure: Stress Scores
timeFrame: Month 6
measure: Healthcare use
timeFrame: Baseline
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Deepak Palakshappa, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: