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

Study Details

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.

Conditions

Food Insecurity

Pregnancy

Study ID

NCT06942598

Start date

Jun 17, 2025

Status verified date

Feb, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

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

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.

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 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).

Primary outcome measure

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 ]