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.

肥胖和糖尿病率继续上升，种族和性别差异持续存在。 23％ 妇女从成年期获得≥20公斤，这与 糖尿病和更大的死亡率。因为许多妇女经历了怀孕，所以过多 妊娠体重增加（GWG）和产后体重保留（PPWR）可能是 妇女及其子女的未来肥胖和糖尿病的可修改贡献者。目的 该R-18的务实随机对照试验（RCT）是测试的有效性 对您的两人 /健康的健康（H42 / H4U），这是一种创新的循证 怀孕/产后健康教练干预措施（电话教练） +基于Web的平台 +手机行为跟踪），旨在促进健康的GWG 和产后减肥。我们将将H42/H4U嵌入到提供服务的产前护理诊所中 种族和经济上多样化的人口，利用现有的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 RCT。我们的目的是1）比较H42/H4U远程保健健康的有效性 与380中的通常护理相比，纳入产前护理中的教练干预措施 来自6家产前诊所的孕妇和产后妇女； 2）评估组织 影响对产前护理诊所进行干预的因素，包括 干预交付的成本以及提供者和员工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超过 GWG，GDM事件，PPWR，婴儿出生体重以及4和6个月的Mater Health 行为（饮食，体育锻炼，母乳喂养）和母子健康（抑郁，睡眠， 压力）。这项研究将推进一种潜在的强大，基于产前护理的策略，以减少 生育妇女的肥胖，从而对孩子产生代际影响。我们的 团队汇集了学术和社区的产科医生，人口健康 计划，以及具有开发，测试和实施行为方面经验的研究人员 在现实世界中，对怀孕和非怀孕成年人的干预措施使宽阔 传播。最终，我们旨在减少肥胖，糖尿病和其他与肥胖有关的 母亲及其子女的并发症，并确保防止高质量的护理服务 肥胖和糖尿病通过人口健康方法来治疗产前护理。