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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06942598
Status
Recruiting
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Conditions

  • Food Insecurity
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

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).

Study Details

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.

Key Dates

Start date
Jun 17, 2025
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: 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.
  • Experimental: 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).
  • Experimental: Produce prescriptions
    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.
  • Experimental: 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. Adherence to meals and food sharing will be measured using food consumption diaries.

Primary Outcome Measure

Feasibility of recruitment - Proportion of eligible patients who enroll [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Deepak Palakshappa, MD, MSHP
[email protected]
336-716-1795
Rebecca Stone, MPH
[email protected]
336-713-5544

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