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

NCT ID: NCT06942598

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2027-02-28

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.

Conditions

Food Insecurity; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

Produce prescription

Intervention Type: BEHAVIORAL

Participants randomized to this arm will receive $10 worth of fruits and vegetables from Help Our People Eat (H.O.P.E) of Winston Salem each week. H.O.P.E is a local non-profit that distributes nutritious meals and fruits and vegetables to neighborhoods throughout Forsyth County to help families with FI. H.O.P.E also collaborates with local farmers to provide a Neighborhood Produce Market that provides low-cost produce. Participants will have the produce delivered to their home each week for 3 months.

Medically tailored meals

Intervention Type: BEHAVIORAL

Medically-tailored meals will be provided by Second Harvest Food Bank of Northwest NC. 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 dietitian. Meals have minimal preparation time, can be heated by stove, oven, or microwave. Because the meals are medically-tailored, participants are asked not to share them.

Electronic Health Record (EHR) referral to Women, Infants and Children (WIC) + 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 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 Type: EXPERIMENTAL

Produce prescription

Intervention Type: BEHAVIORAL

Participants randomized to this arm will receive $10 worth of fruits and vegetables from Help Our People Eat (H.O.P.E) of Winston Salem each week. H.O.P.E is a local non-profit that distributes nutritious meals and fruits and vegetables to neighborhoods throughout Forsyth County to help families with FI. H.O.P.E also collaborates with local farmers to provide a Neighborhood Produce Market that provides low-cost produce. Participants will have the produce delivered to their home each week for 3 months.

Medically tailored meals

Intervention Type: BEHAVIORAL

Medically-tailored meals will be provided by Second Harvest Food Bank of Northwest NC. 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 dietitian. Meals have minimal preparation time, can be heated by stove, oven, or microwave. Because the meals are medically-tailored, participants are asked not to share them.

Interventions

Produce prescription

Participants randomized to this arm will receive $10 worth of fruits and vegetables from Help Our People Eat (H.O.P.E) of Winston Salem each week. H.O.P.E is a local non-profit that distributes nutritious meals and fruits and vegetables to neighborhoods throughout Forsyth County to help families with FI. H.O.P.E also collaborates with local farmers to provide a Neighborhood Produce Market that provides low-cost produce. Participants will have the produce delivered to their home each week for 3 months.

Intervention Type: BEHAVIORAL

Medically tailored meals

Medically-tailored meals will be provided by Second Harvest Food Bank of Northwest NC. 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 dietitian. Meals have minimal preparation time, can be heated by stove, oven, or microwave. Because the meals are medically-tailored, participants are asked not to share them.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deepak Palakshappa, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Deepak Palakshappa, MD, MSHP

Role: CONTACT

dpalaksh@wakehealth.edu

336-716-1795

Rebecca Stone, MPH

Role: CONTACT

rjstone@wakehealth.edu

336-713-5544

Facility Contacts

Deepak Palakshappa, MD, MSHP

Role: primary

dpalaksh@wakehealth.edu

336-716-1795

Rebecca Stone, MPH

Role: backup

rjstone@wakehealth.edu

336-713-5544

References

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 Sep 18;158:108086. doi: 10.1016/j.cct.2025.108086. Online ahead of print.

Reference Type: DERIVED

PMID: 40975433 (View on PubMed)

Other Identifiers

1R01DK141526-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00116098

Identifier Type: -

Identifier Source: org_study_id