Healthy for 2/Healthy for U: A Pragmatic Randomized Clinical Trial to Limit Gestational Weight Gain and Prevent Obesity in the Prenatal Care Setting

2 岁健康/U 健康：一项在产前护理环境中限制妊娠体重增加和预防肥胖的实用随机临床试验

• 批准号: 10581516
• 负责人: Wendy Lynet Bennett
• 金额: $ 70.16万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-10 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10581516
• 关键词: Address; Adult; African American; Age; Behavior; Behavior Therapy; Behavioral; Birth; Birth Weight; Body Weight decreased; Breast Feeding; Caring; Cellular Phone; Child; Clinic; Communities; Community Health Aides; Cost Analysis; Counseling; Development; Diabetes Mellitus; Diet; Discipline of obstetrics; Effectiveness; Enrollment; Ensure; Exercise; Future; Gestational Diabetes; Goals; Health; Health behavior; Health system; High Risk Woman; Incidence; Infant; Intervention; Interview; Investments; Low Birth Weight Infant; Maternal Health; Mental Depression; Mothers; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Online Systems; Outcome; Patient Monitoring; Persons; Physical activity; Population Heterogeneity; Postpartum Period; Postpartum Women; Pregnancy; Pregnancy Complications; Pregnant Women; Prenatal care; Prevention; Provider; Public Health; Publications; Quality of Care; Race; Randomized, Controlled Trials; Research; Research Personnel; Resources; Risk; Sleep; Stress; Structure; Technology; Testing; Weight; Weight Gain; Weight maintenance regimen; Woman; arm; care delivery; child bearing; clinical practice; combat; comorbidity; compare effectiveness; cost; design; dietary; effectiveness testing; efficacy testing; efficacy trial; evidence base; experience; gender disparity; gestational weight gain; health training; implementation intervention; improved; innovation; intergenerational; intervention cost; intervention delivery; lifestyle intervention; men; mobile computing; mortality; motivational enhancement therapy; obesity prevention; obesity risk; population health; postpartum health; postpartum weight; pregnant; prenatal; prevent; primary outcome; programs; racial disparity; randomized, clinical trials; remote delivery; reproductive; satisfaction; secondary outcome; telephone based; telephone coaching; treatment as usual; web platform; young adult

Obesity and diabetes rates continue to rise, and racial and gender disparities persist. 23% of women gain ≥ 20 kg through young adulthood, which is associated with development of diabetes and greater mortality. Because many women experience pregnancy, excessive gestational weight gain (GWG) and post-partum weight retention (PPWR) are potentially modifiable contributors to future obesity and diabetes in both women and their children. The aim of this R-18 Pragmatic Randomized Controlled Trial (RCT) is to test the effectiveness of Healthy for Two / Healthy for You (H42/H4U), an innovative evidence-based pregnancy/postpartum health coaching intervention that is remotely-delivered (phone coaching + web-based platform + mobile phone behavioral tracking), aimed at promoting healthy GWG and postpartum weight loss. We will embed H42/H4U into prenatal care clinics that serve a racially and economically diverse population, leverage existing staff as trained health coaches and community health workers, and test its effectiveness and implementation in a pragmatic RCT. We aim to 1) Compare the effectiveness of the H42/H4U remotely-delivered health coaching intervention integrated into prenatal care compared with Usual Care among 380 pregnant and postpartum women enrolled from 6 prenatal clinics and; 2) Assess organizational factors that impact the implementation of the intervention into prenatal care clinics, including costs of intervention delivery and provider and staff satisfaction to inform future dissemination. The primary outcome will be GWG. Maternal and infant secondary outcomes include excess GWG, GDM incidence, PPWR, infant birth weight and at 4 and 6 months, maternal health behaviors (diet, physical activity, breastfeeding) and maternal wellness (depression, sleep, stress). This study will advance a potentially powerful, prenatal care-based strategy to reduce obesity in childbearing women and thereby the intergenerational effects on their children. Our team brings together academic and community-based obstetricians, a population health program, and researchers with experience in developing, testing and implementing behavioral interventions in both pregnant and non-pregnant adults in real world settings to enable wide dissemination. Ultimately, we aim to reduce obesity, diabetes and other obesity-related complications in mothers and their children, and ensure high quality care delivery that prevents obesity and diabetes through a population health approach to prenatal care.

肥胖率和糖尿病患病率继续上升，种族和性别差异依然存在。23%的 女性通过青春期增加了20公斤的≥，这与 糖尿病和更高的死亡率。因为许多女性经历过怀孕，过度 妊娠期体重增加(GWG)和产后体重滞留(PPWR)是潜在的 妇女及其子女未来肥胖和糖尿病的可改变因素。其目的是 这项R-18务实随机对照试验(RCT)的目的是测试阿司匹林的有效性 两人健康/你健康(H42/H4U)，一种创新的循证 远程提供的孕期/产后健康指导干预(电话指导 +网络平台+手机行为跟踪)，旨在促进GWG健康 和产后减肥。我们将把H42/H4U植入产前护理诊所，为 种族和经济多元化的人口，利用现有员工作为训练有素的健康教练 和社区卫生工作者，并在务实的基础上检验其有效性和实施情况 RCT。我们的目标是1)比较H42/H4U远程医疗服务的有效性 380例围产期干预与常规护理的比较 从6个产前诊所登记的孕妇和产后妇女；2)评估组织 影响产前保健诊所实施干预措施的因素包括 干预措施交付的成本以及提供者和工作人员的满意度，以告知未来的传播。 主要结果将是GWG。母亲和婴儿的次要结果包括过量 GWG、GDM发病率、PPWR、婴儿出生体重及4个月和6个月时、孕产妇健康 行为(饮食、体力活动、母乳喂养)和母亲健康(抑郁、睡眠、 压力)。这项研究将推进一种潜在的强大的、以产前护理为基础的战略，以减少 育龄妇女的肥胖及其对子女的代际影响。我们的 团队汇集了学术和社区产科医生，人口健康 计划，以及在开发、测试和实施行为方面有经验的研究人员 在现实世界中对怀孕和未怀孕的成年人进行干预，以实现广泛的 传播。最终，我们的目标是减少肥胖、糖尿病和其他与肥胖相关的疾病 减少母亲及其子女的并发症，并确保提供高质量的护理，防止 通过人口健康的方法进行产前保健，以预防肥胖和糖尿病。