Berge Jerica M, Trofholz Amanda C, Aqeel Marah, Norderud Kristin, Tate Allan, Fertig Angela R, Loth Katie, Mendenhall Tai, Neumark-Sztainer Dianne
University of Minnesota.
University of Georgia.
Res Sq. 2023 Mar 22:rs.3.rs-2662682. doi: 10.21203/rs.3.rs-2662682/v1.
Numerous observational studies show associations between family meal frequency and markers of child cardiovascular health including healthful diet quality and lower weight status. Some studies also show the "quality" of family meals, including dietary quality of the food served and the interpersonal atmosphere during meals, is associated with markers of child cardiovascular health. Additionally, prior intervention research indicates that immediate feedback on health behaviors (e.g., ecological momentary intervention (EMI), video feedback) increases the likelihood of behavior change. However, limited studies have tested the combination of these components in a rigorous clinical trial. The main aim of this paper is to describe the study design, data collection protocols, measures, intervention components, process evaluation, and analysis plan. The intervention utilizes state-of-the-art intervention methods including EMI, video feedback, and home visiting by Community Health Workers (CHWs) to examine whether increasing the quantity (i.e., frequency) and quality of family meals (i.e., diet quality, interpersonal atmosphere) improves child cardiovascular health. is an individual randomized controlled trial that tests combinations of the above factors across three study Arms: (1) EMI; (2) EMI+Virtual Home Visiting with CHW+Video Feedback; and (3) EMI+Hybrid Home Visiting with CHW+Video Feedback. The intervention will be carried out across 6 months with children ages 5-10 (n=525) with increased risk for cardiovascular disease (i.e., BMI ≥75%ile) from low income and racially/ethnically diverse households and their families. Data collection will occur at baseline, post-intervention, and 6 months post-intervention. Primary outcomes include child weight, diet quality, and neck circumference. This study will be the first to our knowledge to use multiple innovative methods simultaneously including ecological momentary assessment, intervention, video feedback and home visiting with CHWs within the novel intervention context of family meals to evaluate which combination of intervention components are most effective in improving child cardiovascular health. The intervention has high potential public health impact as it aims to change clinical practice by creating a new model of care for child cardiovascular health in primary care. This trial is registered in clinicaltrials.gov (Trial ID: NCT02669797). Date recorded 5/02/22.
大量观察性研究表明，家庭用餐频率与儿童心血管健康指标之间存在关联，包括健康的饮食质量和较低的体重状况。一些研究还表明，家庭用餐的“质量”，包括所提供食物的饮食质量和用餐时的人际氛围，与儿童心血管健康指标相关。此外，先前的干预研究表明，对健康行为的即时反馈（例如，生态瞬时干预（EMI）、视频反馈）会增加行为改变的可能性。然而，在严格的临床试验中，测试这些因素组合的研究有限。本文的主要目的是描述研究设计、数据收集方案、测量方法、干预组成部分、过程评估和分析计划。该干预采用了包括EMI、视频反馈和社区卫生工作者（CHW）家访在内的最先进干预方法，以研究增加家庭用餐的数量（即频率）和质量（即饮食质量、人际氛围）是否能改善儿童心血管健康。这是一项个体随机对照试验，在三个研究组中测试上述因素的组合：（1）EMI；（2）EMI + CHW虚拟家访 + 视频反馈；（3）EMI + CHW混合家访 + 视频反馈。该干预将对5至10岁（n = 525）、来自低收入且种族/民族多样家庭且心血管疾病风险增加（即BMI≥第75百分位数）的儿童及其家庭进行，为期6个月。数据收集将在基线、干预后和干预后6个月进行。主要结果包括儿童体重、饮食质量和颈围。据我们所知，本研究将是首个在家庭用餐这一新型干预背景下同时使用多种创新方法的研究，这些方法包括生态瞬时评估、干预、视频反馈以及CHW家访，以评估哪种干预组成部分的组合在改善儿童心血管健康方面最有效。该干预具有很高的潜在公共卫生影响，因为它旨在通过创建一种针对初级保健中儿童心血管健康的新护理模式来改变临床实践。本试验已在clinicaltrials.gov上注册（试验编号：NCT02669797）。记录日期为2022年2月5日。
