Feasibility of an ADAPTive intervention to improve food security and Maternal-Child Health (ADAPT-MCH): Protocol for a pilot sequential multiple assignment randomized trial

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-09-18 DOI:10.1016/j.cct.2025.108086

Deepak Palakshappa , Rebecca J. Stone , Brenda Ramirez , Sarah E. White , Joseph Rigdon , Richa Bundy , Sally G. Eagleton , Nicole Caudill , Heather Martin , Mayte Grundseth , Scott Best , Morgana Mongraw-Chaffin , Kristina H. Lewis , Kimberly Montez

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引用次数: 0

Abstract

Background

Food 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/design

We 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.

Conclusions

This 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 registration

The study was registered with ClinicalTrials.gov (NCT06942598) on April 23, 2025.

查看原文本刊更多论文

改善粮食安全和母婴健康的适应性干预（ADAPT-MCH）的可行性：一项试点顺序多任务随机试验方案。

背景：粮食不安全影响到高达30% %的怀孕，并与孕产妇和婴儿健康恶化有关。卫生保健系统正在实施干预措施，以帮助粮食不安全的患者，但不是提供单一的干预措施，而是适应性地提供干预措施可能是一种更有效的策略。本研究的目的是确定适应性地提供干预措施以帮助报告粮食不安全的怀孕患者的可行性。方法/设计：我们将在一个卫生系统的产科诊所进行一项顺序多任务随机试验。怀孕和食物不安全的成年人（N = 60）将在初次产前访问时随机选择两种第一阶段干预措施之一，为期3 个月：1)电子健康记录（EHR）转介到WIC或2)EHR转介到WIC + 护理导航。在3 个月后，食品不安全状况没有改善≥2点的参与者将被重新随机分配到另外3 个月的两个第二阶段干预措施之一：每周提供1)农产品或2)医疗定制膳食。在目标1中，我们将确定招募的可行性，在目标2中，我们将评估重新随机化、保留和数据收集的可行性。在目标3中，我们将通过半结构化访谈加深我们对参与者如何、为什么以及在什么情况下实现改进的理解。结论：这将是第一个测试适应性干预以帮助食物不安全的孕妇的研究，并将为未来的全面试验提供信息。鉴于卫生系统对粮食不安全问题的兴趣日益浓厚，可以广泛传播一种有效的适应性粮食不安全干预措施。试验注册：该研究于2025年4月23日在ClinicalTrials.gov （NCT06942598）注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.