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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Wake Forest University Health Sciences • ClinicalTrials.gov ID: NCT06942598

Registry updated: 2026-10-02
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Description

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.

Interventions

  • Produce prescription (Behavioral)
    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.
  • Medically tailored meals (Behavioral)
    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. Adherence to meals and food sharing will be measured using food consumption diaries
  • Electronic health record WIC referral (Behavioral)
    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.
  • Electronic health record WIC referral + care navigation (Behavioral)
    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).

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)

Conditions

Food Insecurity Pregnancy

Locations

  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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