Randomized Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women

描述（由申请人提供）：西班牙裔女性是美国增长最快的少数群体，与非西班牙裔白人女性相比，她们更有可能在怀孕时超重或肥胖。这项随机对照试验的总体目标是测试一种文化和语言修改的、个性化定制的生活方式干预的有效性，以减少超重/肥胖西班牙裔妇女的妊娠期体重增加（GWG），增加产后体重减轻，并改善产妇代谢状况。具体目的是评估干预对以下方面的影响：1)GWG和产后体重减轻；2)妊娠和产后胰岛素抵抗生物标志物（即葡萄糖、胰岛素、HbA1c、HOMA、瘦素、脂联素）；3)产后心血管风险生物标志物（即血脂、血压）；4)后代结局（即人体测量和胰岛素抵抗生物标志物）。5)评估结果变量的每平均增量改善的干预成本效益。超重/肥胖的西班牙裔妇女将在怀孕早期（妊娠10周）招募，并随机分配到生活方式干预组（n=150）或比较健康和保健（对照）干预组（n=150）。干预将使用适合西班牙裔文化的运动（R01NR011295）和饮食干预材料（R18DK067549），并在我们之前对该种族的对照试验中显示有效。多式联系法(即面对面、电话咨询、

DESCRIPTION (provided by applicant): Hispanic women are the fastest growing minority group in the US and are more likely to begin their pregnancies overweight or obese as compared to non-Hispanic white women. The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually- tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women. Specific aims are to evaluate the impact of the intervention on 1) GWG and postpartum weight loss, 2) pregnancy and postpartum biomarkers of insulin resistance (i.e., glucose, insulin, HbA1c, HOMA, leptin, adiponectin), 3) postpartum biomarkers of cardiovascular risk (i.e., blood lipids, blood pressure), 4) offspring outcomes (i.e., anthropometric measures and biomarkers of insulin resistance), and 5) to evaluate the cost-effectiveness of the intervention per average incremental improvement in the outcome variables. Overweight/obese Hispanic women will be recruited in early pregnancy (10 weeks gestation) and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) Intervention (n=150). The intervention will utilize exercise (R01NR011295) and dietary intervention materials (R18DK067549) culturally adapted for Hispanics and shown to be efficacious in our previous controlled trials in this ethnic group. Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention during pregnancy (12 wks gestation to delivery) continuing into postpartum (6 wks to 6 mos postpartum); follow-up will continue to 1 yr postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for GWG and postpartum weight loss; ACOG guidelines for physical activity through increasing walking and developing a more active lifestyle; and reduction in total calories by following a balanced healthy diet in compliance with American Diabetes Association guidelines. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies for partner and/or family support to address the specific social, cultural, and economic challenges faced by underserved Hispanic women. Measures of compliance will include actigraphs and Hispanic food frequency questionnaires. The proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of exercise interventions among Hispanic pregnant women (R01 DK074876) and dietary interventions among low-income Hispanics with type 2 diabetes (R18 DK0658850) and can readily be translated into clinical practice in underserved and minority populations.