Food FARMacia: Reducing Childhood Obesity in Households with Food Insecurity

摘要 儿童肥胖症仍然非常普遍，并且起源于生命的早期。有效的早期生活干预， 预防儿童肥胖的措施缺乏，特别是在儿童肥胖负担最重的人群中。 粮食不安全-定义为缺乏足够的食物来维持积极、健康的生活-可能在以下方面发挥关键的上游作用： 通过建立不健康的饮食模式和与压力相关的代谢， 扰动生命头24个月的家庭粮食不安全是儿童后期的一个风险因素 肥胖专业组织建议将家庭粮食不安全筛查纳入日常工作 儿科初级保健。然而，在确定有效的临床干预措施以减少 粮食不安全。在理解粮食不安全与疟疾病因之间的关系方面存在另一个差距。 肥胖Food FARMacia是一种基于临床的移动的食品储藏室干预，旨在解决 儿科患者中普遍存在粮食不安全问题。没有临床移动的食品的随机试验 在儿科初级保健中存在食品储藏室干预。了解粮食不安全在粮食短缺病因中的作用， 儿童肥胖症、减少粮食不安全的有效干预措施是必要的。测试食物的功效 在随机临床试验（RCT）中进行FARMacia干预，首先必须确定RCT程序的可行性。 确立了习 本研究的总体目标是在临床上对FARMacia食品进行IIb期试点和可行性RCT 基于移动的食品储藏室干预，以促进健康的体重在婴儿期相比， 控制超过6个月。我们将招募70个家庭（每组随机化n = 35个婴儿-父母配对）， 在常规电子健康记录筛查中发现的6至<18个月婴儿和粮食不安全， 儿科初级保健访问在我们的多站点城市学术卫生保健系统。我们会研究可行性 使用定量和定性方法评估RCT程序和干预成分的可接受性 研究方法我们将评估干预对婴儿体重特征的影响， 进行全面的试验我们将探索干预效应的潜在介质，包括家庭食品 不安全感我们的多学科团队在儿童肥胖、营养、社区参与和 人口健康研究;临床试验;定性研究;和生物统计学。结果将立即通知 一项全面的III期随机对照试验，以测试FARMacia食品干预对预防儿童 肥胖全面试验的结果还将提供有关家庭食物之间关系的新信息， 婴儿期的不安全感和肥胖的病因。如果成功，这项研究将加速识别 可扩展的、有效的临床干预措施，以改变临床护理，减少粮食不安全， 促进婴儿健康成长。

ABSTRACT Childhood obesity remains highly prevalent and originates early in life. Efficacious early life interventions to prevent childhood obesity are lacking, particularly among populations most burdened by childhood obesity. Food insecurity - defined as lack of enough food for an active, healthy life – may play key upstream roles in etiologies of obesity through establishment of unhealthy dietary patterns and stress-related metabolic perturbations. Household food insecurity during the first 24 months of life is a risk factor for later childhood obesity. Professional organizations recommend integration of household food insecurity screening into routine pediatric primary care. Yet, a critical gap exists in identification of efficacious clinical interventions to reduce food insecurity. Another gap exists in understanding relationships between food insecurity and etiologies of obesity. Food FARMacia is a clinically based mobile food pantry intervention developed to address the high prevalence of food insecurity among pediatric patients. No randomized trials of a clinically-based mobile food pantry intervention in pediatric primary care exist. To understand the role of food insecurity in etiologies of childhood obesity, efficacious interventions to reduce food insecurity are needed. To test efficacy of the Food FARMacia intervention in a randomized clinical trial (RCT), feasibility of RCT procedures must first be established. The overall goal of this study is to perform a Phase IIb pilot and feasibility RCT of the Food FARMacia clinically based mobile food pantry intervention to promote healthy weight during infancy compared to an attention control over 6 months. We will recruit 70 families (randomized n = 35 infant-parent dyads per arm) with an infant age 6 to <18 months and food insecurity identified on routine electronic health record screening at pediatric primary care visits in our multi-site urban academic health care system. We will examine feasibility and acceptability of the RCT procedures and intervention components using quantitative and qualitative research methods. We will estimate the effects of the intervention on infant weight characteristics over time to inform a full-scale trial. We will explore potential mediators of intervention effects, including household food insecurity. Our multidisciplinary team has expertise in childhood obesity, nutrition, community-engaged, and population health research; clinical trials; qualitative research; and biostatistics. Results will immediately inform a full-scale Phase III RCT to test the efficacy of the Food FARMacia intervention on preventing childhood obesity. Results of a full-scale trial will also provide new information about relationships of household food insecurity during infancy and etiologies of obesity. If successful, this research will accelerate identification of scalable, efficacious clinical interventions to transform clinical care for reduction of food insecurity and promotion of healthy infant growth.