ArticleContemporary clinical trials2025
Feasibility of an ADAPTive intervention to improve food security and Maternal-Child Health (ADAPT-MCH): Protocol for a pilot sequential multiple assignment randomized trial.
Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06942598 (Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health), which is not on this map. Not yet cited in PubMed.
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Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health (ADAPT-MCH)
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14 authors.
Funding
Abstract
backgroundFood insecurity affects up to 30 % of pregnancies and is associated with worse maternal and infant health. Healthcare systems are implementing interventions to assist patients with food insecurity, but rather than providing a single intervention, adaptively providing interventions could be a more effective strategy. The objective of this study is to determine the feasibility of adaptively providing interventions to assist pregnant patients who report being food-insecure. METHODS/
designWe will conduct a pilot sequential multiple assignment randomized trial at obstetrics clinics from one health system. Adults (N = 60) who are pregnant and food-insecure will be randomized at their initial prenatal visit to one of two first-stage interventions for 3 months: 1) electronic health record (EHR) referral to WIC or 2) EHR-referral to WIC + care navigation. Participants who do not have ≥2-point improvement in food insecurity after 3 months will be re-randomized to one of two second-stage interventions for an additional 3 months: weekly delivery of 1) produce or 2) medically-tailored meals. In Aim 1, we will determine the feasibility of recruitment, and in Aim 2, we will evaluate the feasibility of re-randomization, retention, and data collection. In Aim 3, we will advance our understanding of how, why, and under what circumstances participants achieved improvements through semi-structured interviews.
conclusionsThis will be the first study to test an adaptive intervention to assist pregnant patients with food insecurity and will inform a future fully-powered trial. Given the growing interest among health systems, an efficacious, adaptive food insecurity intervention could be broadly disseminated.
trial registrationThe study was registered with ClinicalTrials.gov (NCT06942598) on April 23, 2025.
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