NCT06942598 · Wake Forest University Health Sciences
Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health
(ADAPT-MCH)
What this study is about
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).
View original scientific 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
BEHAVIORAL
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.
BEHAVIORAL
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
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Feasibility of recruitment - Proportion of eligible patients who enroll
Time frame: Baseline
Proportion of eligible patients who enroll in the study based on study logs
Feasibility of retention - Proportion of eligible participants
Time frame: Month 6
The proportion of eligible participants who complete 3-month and 6-month follow-up data collection based on study log
Feasibility of re-randomization - Proportion of eligible participants
Time frame: Month 3
The proportion of eligible participants who are re-randomized to a stage 2 intervention based on study log.
Food insecurity Scores
Time frame: Month 6
Survey participants using the validated 10-item USDA Adult FSSM, with a 30-day look back period. The tool measures food security over the prior 30 days. Using the standardized scoring provided by the USDA to assess participants responses. This produces a raw score that ranges from 0 to 10 with higher scores indicating worse FI. High Food Security: Raw score of 0. Marginal Food Security: Raw score of 1-2. Low Food Security: Raw score of 3-5. Very Low Food Security: Raw score of 6-1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Winston-Salem, North Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2026 · Source of record for eligibility and locations