StEP OUT

退出

• 批准号: 10449005
• 负责人: Michelle Weiss Katzow
• 金额: $ 19.08万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10449005
• 关键词: 2 year old; 2019-nCoV; Address; Adult; Adverse event; Attitude; Belief; Bottle feeding; Breast Feeding; COVID-19; Cardiometabolic Disease; Child; Child Rearing; Childhood; Clinical Trials; Communities; Conduct Clinical Trials; Coupled; Cues; Data; Development; Dose; Enrollment; Epidemic; Exposure to; Family; Food; Frequencies; Funding; Future; Geography; Health; High Prevalence; Infant; Interruption; Intervention; Knowledge; Latina; Latinx; Low income; Measures; Mentored Patient-Oriented Research Career Development Award; Mentors; Methods; Morbidity - disease rate; Mothers; National Heart, Lung, and Blood Institute; Obesity; Outcome; Overweight; Parents; Participant; Persons; Postpartum Period; Predisposition; Pregnancy; Prevention program; Preventive; Primary Health Care; Process; Psychosocial Stress; Qualitative Methods; Randomized; Randomized Controlled Trials; Research Personnel; Resources; Risk Factors; Sample Size; Sampling; Science; Social Conditions; Special Supplemental Nutrition Program for Women, Infants, and Children; Technology; Testing; Time; Videoconferencing; Visit; Vulnerable Populations; Weight; Woman; acceptability and feasibility; base; cardiometabolism; career; career development; cohort; community based participatory research; design; disease disparity; disparity elimination; early childhood; efficacy testing; efficacy trial; ethnic disparity; evidence base; experience; feeding; high risk; high risk population; improved; infancy; infant adiposity; innovation; insight; lower income families; minority communities; mortality; nutrition; nutrition education; obesity in children; obesity prevention; obesity risk; pandemic disease; pilot test; post-doctoral training; power analysis; pregnant; prenatal; prevent; preventive intervention; primary care setting; programs; recruit; remote delivery; response; skill acquisition; skills; social health determinants; socioeconomic disparity; stem; sugar; sweetened beverage; telehealth; usability; virtual delivery

PROJECT SUMMARY/ABSTRACT This Mentored Patient-Oriented Research Career Development Award (K23) proposal will address an urgent need to advance the science of child obesity prevention in low-income, minority communities, a priority of the National Heart, Lung, and Blood Institute. Simultaneously, it will prepare the applicant, Michelle Katzow, MD, MS, to become an independent investigator specializing in interventions that begin in pregnancy to prevent child obesity using innovative and scalable delivery platforms. Risk factors for lifelong cardiometabolic morbidity and mortality related to obesity are identifiable in pregnancy and early infancy, with the highest prevalence in low-income, Latinx communities. Few interventions have improved child obesity related outcomes in this high-risk group. The Starting Early Program (StEP) was designed to fill this gap. The program delivers nutrition and parenting support sessions in the primary care setting and has significant positive impacts on child obesity-related outcomes. These impacts are dose dependent, such that families who attend more sessions have significantly better outcomes than families who attend fewer sessions. Many families cite geographic distance as a major barrier to program engagement. Though the original program was delivered in person, a second cohort receiving the program in 2020 experienced a rapid conversion to remote, videoconference delivery due to the global pandemic. Despite many challenges posed by the pandemic, attendance among participants in this ongoing cohort has been higher than among participants in the original, in-person cohort. In addition to improving attendance, remote delivery has created opportunities for more frequent sessions than would be typical in contexts outside of primary care that are otherwise well-suited for obesity prevention programs, such as the Special Supplemental Nutrition Program for Women, Infants, & Children (WIC). WIC reaches more than half of all infants in the nation and has a high concentration of children at risk of obesity. However, no studies have examined videoconference-based, longitudinal interventions for child obesity prevention in WIC. This K23 proposes to develop and test Starting Early to Prevent Obesity Using Telehealth (StEP OUT), an adapted version of StEP optimized for remote, virtual delivery through WIC. Aim 1 will identify knowledge and attitudes of key stakeholders likely to impact engagement and outcomes of StEP OUT; Aim 2 will iteratively adapt and test StEP OUT in sequential small cohorts; and Aim 3 will conduct a pilot randomized controlled trial (RCT) to evaluate acceptability and feasibility of StEP OUT. In the process, the candidate will obtain essential career development skills in four domains: 1) qualitative methods; 2) CBPR; 3) iterative intervention adaptation; and 4) conduct of clinical trials in vulnerable populations. The resources of Northwell Health and an expert team of interdisciplinary mentors and advisors will provide an outstanding context to launch Dr. Katzow’s career. This project will provide the necessary data for Dr. Katzow’s future R01 submission of a large-scale RCT testing the efficacy of StEP OUT.

项目概要/摘要 这项以患者为导向的研究职业发展奖 (K23) 提案将解决一个紧迫的问题 需要在低收入、少数群体社区中推进预防儿童肥胖的科学，这是该国的优先事项 同时，国家心肺血液研究所将为申请人 Michelle Katzow 医学博士做好准备。 MS，成为一名独立调查员，专门从事从怀孕开始的干预措施，以预防 使用创新和可扩展的交付平台研究儿童肥胖症的终生心脏代谢风险因素。 与肥胖相关的发病率和死亡率在妊娠期和婴儿早期即可识别，其中最高 低收入拉丁裔社区的患病率很少有干预措施能够改善与儿童肥胖相关的情况。 早期开始计划 (StEP) 旨在填补这一空白。 在初级保健机构中提供营养和育儿支持课程，并具有显着的积极作用 对儿童肥胖相关结果的影响 这些影响是剂量依赖性的，因此参加的家庭。 许多家庭表示，参加次数越多的家庭比参加次数越少的家庭效果更好。 尽管最初的计划是在 2017 年交付的，但地理距离仍然是计划参与的主要障碍。 人，2020 年接受该计划的第二批人经历了快速转变为远程、 尽管大流行带来了许多挑战，但由于全球大流行，视频会议的交付仍然存在。 这个正在进行的队列的参与者的出席率比原来的要高， 除了提高出席率之外，远程交付还为更多人创造了机会。 比初级保健以外的环境中的典型情况更频繁的会议，否则非常适合 肥胖预防计划，例如针对妇女、婴儿和儿童的特殊补充营养计划 儿童 (WIC)。WIC 覆盖全国一半以上的婴儿，并且儿童集中度很高。 然而，没有研究检验基于视频会议的纵向干预措施。 WIC 中的儿童肥胖预防措施 此 K23 建议开发和测试“尽早开始预防肥胖”的方法。 远程医疗 (StEP OUT)，StEP 的改编版本，针对通过 WIC Aim 1 进行远程虚拟交付进行了优化。 将确定可能影响 StEP 参与和结果的关键利益相关者的知识和态度 OUT；目标 2 将在连续的小队列中迭代调整和测试 StEP OUT；目标 3 将进行试点； 随机对照试验（RCT）评估 StEP OUT 的可接受性和可行性。 候选人将获得四个领域的基本职业发展技能：1）定性方法；2）CBPR； 迭代干预适应；4）在弱势群体中进行临床试验的资源。 Northwell Health 和由跨学科导师和顾问组成的专家团队将提供出色的 该项目将为 Katzow 博士未来的 R01 提供必要的数据。 提交大规模 RCT 测试 StEP OUT 的功效。