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.

肥胖和糖尿病的发病率持续上升，种族和性别差异依然存在。23%的