Food is the Best Medicine (FBM): design and baseline findings from a multi-arm randomized controlled trial among food-insecure postpartum mothers in Texas

BACKGROUND: Food is Medicine (FIM) interventions, which connect health-supporting food programs with healthcare systems, demonstrate substantial clinical and economic benefits. However, few FIM studies have focused on the health of postpartum mothers, a population facing unique vulnerabilities during a critical period. Food is the Best Medicine (FBM) is an 8-week, home-delivery-based FIM intervention targeting postpartum mothers experiencing food insecurity. Developed through partnerships between healthcare providers and community-based organizations, the FBM intervention integrates food delivery with supportive services. Here, we describe the research design and present baseline findings of a study evaluating the impacts of supplementing the FBM intervention with different sustainability-enhancing modalities. METHODS: The Food is the Best Medicine (FBM) study was a three-arm randomized controlled trial conducted in Central Texas. Food-insecure postpartum mothers (n = 150) were randomized to receive: (1) FBM-Standard (8-week food delivery), (2) FBM-CHW (standard delivery plus Community Health Worker (CHW) support), or (3) FBM-Virtual (standard delivery plus online educational platform). Primary planned outcome measures included food security and fruit, vegetables, and whole grain intake. Secondary planned outcome measures included nutrition security, breastfeeding rates, mental health, financial stress, and cooking behaviors. Baseline data were collected via telephone or online surveys prior to randomization. RESULTS: Participants were predominantly Hispanic (71%) and Spanish-speaking (79%), with a mean household income of $20,620 (SD = $18,190). Most lived in households with multiple children (74%), in which the number of children and adults ranged from 1 to 15 and 1 to 9, respectively, and had limited formal education (38% without a high school diploma). Marital status was not collected. At baseline, 89% were food insecure. Depression screening indicated mental health concerns in 13% of participants. The 10-item Dietary Screener Questionnaire was used to assess fruit and vegetable intake. Mean fruit and vegetable consumption was 3.9 cups daily, but consumption of whole-grain bread and cooked whole grains was low, at about once a week. CONCLUSIONS: The FBM study uses a multi-component, randomized design to evaluate variations of a FIM intervention among food-insecure postpartum mothers. The intervention incorporates food delivery, CHW support, and virtual education components. Ongoing analyses will assess the potential of these approaches to improve food security and related maternal health outcomes in the postpartum period. TRIAL REGISTRATION: ClinicalTrials.gov NCT06428578 (registered May 20, 2024).