2-Generation Interventions to Improve Cardiovascular Health in Indiana and Illinois Through Home Visiting (2-NOURISH)

通过家访改善印第安纳州和伊利诺伊州心血管健康的第二代干预措施 (2-NOURISH)

• 批准号: 10622594
• 负责人: Matthew M Davis
• 金额: $ 81.48万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-16 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10622594
• 关键词: 3 year old; 5 year old; Address; Adoption; Age; American Heart Association; Behavior Therapy; Birth; Body mass index; Cardiovascular Diseases; Cause of Death; Child; Childhood; Clinical Trials Design; Cognitive Therapy; Collaborations; Communities; Data; Development; Disparity; Early Intervention; Effectiveness; Eligibility Determination; Enrollment; Ensure; Equity; Ethnic Origin; Evidence based intervention; Family; Generations; Geography; Goals; Health; Health Policy; Health Promotion; Health behavior; High Prevalence; Home; Home visitation; Illinois; Impaired cognition; Implementation readiness; Indiana; Individual; International; Intervention; Intervention Studies; Life Cycle Stages; Link; Maintenance; Maternal Mortality; Maternal and Child Health; Measures; Mental Depression; Mental Health; Mission; Modeling; Monitor; Mothers; National Heart, Lung, and Blood Institute; Network-based; Obesity; Outcome; Overweight; Parents; Participant; Perinatal; Phase; Population; Population Heterogeneity; Populations at Risk; Positioning Attribute; Postpartum Period; Pregnancy; Protocols documentation; Psychosocial Factor; Qualifying; Race; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research Design; Research Personnel; Resources; Risk; Science; Services; Societies; Socioeconomic Status; Techniques; Testing; Time; United States; United States Preventative Services Task Force; Weight; Work; cardiovascular disorder risk; cardiovascular health; clinical center; clinical research site; clinically relevant; cluster randomized design; cost; disability; early childhood; effectiveness evaluation; effectiveness testing; effectiveness/implementation hybrid; evidence base; experience; health assessment; health disparity; health of the mother; healthy weight; implementation evaluation; implementation outcomes; implementation science; improved; in utero; innovation; intergenerational; intervention participants; lifestyle intervention; maternal morbidity; multi-component intervention; multidisciplinary; multiple chronic conditions; offspring; patient navigation; peer support; perinatal period; peripartum depression; pilot test; pregnant; prenatal; programs; psychosocial; recruit; response; sex; skills; stress management; success; teacher; timeline; transmission process; virtual delivery; virtual platform; young adult

PROJECT SUMMARY This application proposing the 2-GeneratioN Interventions to ImprOve CardiovascUlaR Health in Indiana and IllinoiS Through Home Visiting (2-NOURISH) is in response to the RFA “Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite Clinical Center (RFA-HL-22-007)”. Given growing rates of maternal morbidity and mortality, interventions to optimize maternal cardiovascular health (CVH) are urgently needed. Poor maternal CVH is also associated with poor offspring CVH. As a result, the perinatal period is an opportune time to intervene, but evidence-based interventions are limited. Home visiting (HV) programs serve as an ideal setting to conduct intervention research aimed at improving maternal and child CVH as they already serve an at-risk population across the United States with a high prevalence of poor CVH. The proposed Clinical Center, 2-NOURISH, led by Northwestern, in partnership with two evidence-based HV models (Healthy Families America [HFA] and Parents as Teachers [PAT]), and an evidence-based virtual platform for lifestyle intervention, Weight Watchers International (WW), is uniquely qualified to participate in all aspects of the ENRICH Network and to substantially enhance the Network’s goals. In our application, we demonstrate key prior experiences, which include: (1) long-standing collaborations with HV models, including MPI Tandon’s evidence-based perinatal depression and stress management intervention (Mothers and Babies); (2) significant expertise in the development and assessment of maternal and child CVH, particularly during the perinatal period; and (3) extensive experience with recruitment and retention of diverse populations for behavior interventions. During the UG3 phase (Years 1-2), we will work collaboratively within the ENRICH Network to develop a common study protocol, adapt the intervention content, and conduct pilot tests. During the UH3 phase (Years 3-7), we will recruit 600 mother-child dyads in partnership with 40 HV programs in Illinois and Indiana within the proposed study timeline to achieve the ENRICH Network Goal of 3000 total dyads to examine the effectiveness of an implementation-ready, CVH-focused, evidence-based intervention. We carefully considered potential study designs and propose a Hybrid Effectiveness-Implementation Type 1 trial with a cluster randomized design that would randomize at the home visitor-level. Additionally, given the potential maternal and offspring benefits of intervention during pregnancy, we propose prenatal recruitment. Our proposed intervention also includes innovative prenatal (promotion of stress management techniques, home visitor patient navigation) and postpartum (intensive lifestyle intervention with a virtual delivery platform, peer support) components. Our Clinical Center is additionally committed to developing the skills of Early Stage Investigators related to clinical trial design and the skills of home visitors related to the construct of CVH, its components, and the common study protocol. 2-NOURISH is ideally suited to serve as a Clinical Center and contribute to the Network’s long-term mission to equitably improve maternal and early childhood CVH.

项目总结