Vanderbilt University Medical Center, Department of Pediatrics, 2200 Children's Way, Suite 2404, Nashville, TN 37232, United States of America.
Johns Hopkins University, Department of Pediatrics, Schools of Medicine and Nursing, 200 N. Wolfe St, Rubenstein Building-2071, Baltimore, MD 21287, United States of America.
Contemp Clin Trials. 2022 Dec;123:106987. doi: 10.1016/j.cct.2022.106987. Epub 2022 Oct 30.
The first 1000 days of a child's life are increasingly recognized as a critical window for establishing a healthy growth trajectory to prevent childhood obesity and its associated long-term comorbidities. The purpose of this manuscript is to detail the methods for a multi-site, comparative effectiveness trial designed to prevent childhood overweight and obesity from birth to age 2 years.
This study is a multi-site, individually randomized trial testing the comparative effectiveness of two active intervention arms: 1) the Greenlight intervention; and 2) the Greenlight Plus intervention. The Greenlight intervention is administered by trained pediatric healthcare providers at each well-child visit from 0 to 18 months and consists of a low health literacy toolkit used during clinic visits to promote shared goal setting. Families randomized to Greenlight Plus receive the Greenlight intervention plus a health information technology intervention, which includes: 1) personalized, automated text-messages that facilitate caregiver self-monitoring of tailored and age-appropriate child heath behavior goals; and 2) a web-based, personalized dashboard that tracks child weight status, progress on goals, and electronic Greenlight content access. We randomized 900 parent-infant dyads, recruited from primary care clinics across six academic medical centers. The study's primary outcome is weight for length trajectory from birth through 24 months.
By delivering a personalized and tailored health information technology intervention that is asynchronous to pediatric primary care visits, we aim to achieve improvements in child growth trajectory through two years of age among a sample of geographically, socioeconomically, racially, and ethnically diverse parent-child dyads.
儿童生命的头 1000 天正逐渐被视为建立健康成长轨迹的关键时期,以预防儿童肥胖及其相关的长期合并症。本文旨在详细介绍一项多中心、比较有效性试验的方法,该试验旨在从出生到 2 岁预防儿童超重和肥胖。
这是一项多中心、个体随机试验,测试两种积极干预措施的比较效果:1)绿灯干预;2)绿灯加干预。绿灯干预由训练有素的儿科医疗保健提供者在每次儿童健康检查时从 0 至 18 个月进行,包括一个低健康素养工具包,用于在诊所就诊时促进共同目标设定。随机分配到绿灯加组的家庭将接受绿灯干预加健康信息技术干预,包括:1)个性化、自动发送的短信,方便照顾者自我监测定制和适合年龄的儿童健康行为目标;2)一个基于网络的个性化仪表板,跟踪儿童体重状况、目标进展情况以及电子绿灯内容的访问。我们随机招募了 900 对母婴,来自六个学术医疗中心的初级保健诊所。该研究的主要结果是从出生到 24 个月的体重长度轨迹。
通过提供个性化和定制的健康信息技术干预,与儿科初级保健就诊异步进行,我们旨在通过两年的时间改善地理、社会经济、种族和民族多样化的母婴对儿童生长轨迹的影响。