Randomized Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women

描述（由申请人提供）：西班牙裔妇女是美国增长最快的少数群体，与非西班牙裔白色妇女相比，她们更有可能在怀孕开始时超重或肥胖。这项随机对照试验的总体目标是测试文化和语言上修改的、个体定制的生活方式干预在超重/肥胖西班牙裔妇女中减少过度妊娠体重增加（GWG）、增加产后体重减轻和改善母体代谢状态的功效。具体目的是评估干预对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）产后心血管风险的生物标志物（即，血脂，血压），4）后代结果（即，人体测量和胰岛素抵抗的生物标志物），和5）评估结果变量中每平均增量改善的干预的成本效益。超重/肥胖西班牙裔女性将在妊娠早期（妊娠10周）招募，并随机分配至生活方式干预组（n = 150）或健康和健康（对照）比较干预组（n = 150）。该干预将利用运动（R01NR011295）和饮食干预材料（R18DK067549），这些材料在文化上适合西班牙裔美国人，并在我们之前在该种族群体中进行的对照试验中显示有效。多模式接触（即，面对面，电话咨询， 和邮寄的印刷材料）将用于在妊娠期间（妊娠12周至分娩）持续至产后（产后6周至6个月）提供干预;随访将持续至产后1年。干预的目标是实现GWG和产后体重减轻的医学研究所指南; ACOG通过增加步行和发展更积极的生活方式进行体力活动的指南;以及通过遵循美国糖尿病协会指南的平衡健康饮食减少总卡路里。干预措施借鉴了社会认知理论和跨理论模型，并包括合作伙伴和/或家庭支持的战略，以解决特定的社会，文化， 西班牙裔妇女面临的经济挑战。依从性的措施将包括活动记录仪和西班牙裔食物频率问卷。拟议的项目建立在调查小组在西班牙裔孕妇（R01 DK074876）和低收入西班牙裔2型糖尿病患者（R18 DK0658850）中进行运动干预的随机对照试验的专业知识基础上，可以很容易地转化为服务不足和少数群体的临床实践。

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.