Randomized Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women

描述(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，她们更有可能开始怀孕、超重或肥胖。这项随机对照试验的总体目标是测试一种经过文化和语言修改的、个性化的生活方式干预的有效性，以减少超重/肥胖的拉美裔妇女的过度妊娠体重增加(GWG)，增加产后体重减轻，并改善母亲的代谢状况。具体目的是评估干预对以下方面的影响：1)体重和产后体重下降，2)妊娠和产后胰岛素抵抗的生物标记物(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记物(即血脂、血压)，4)后代结局(即人体测量指标和胰岛素抵抗的生物标记物)，以及5)评估干预措施对结局变量的平均增量改善的成本效益。超重/肥胖的西班牙裔妇女将在怀孕早期(怀孕10周)被招募，并随机分配到生活方式干预组(n=150)或比较健康和健康(对照)干预组(n=150)。干预将使用锻炼(R01NR011295)和饮食干预材料(R18DK067549)，这些材料在文化上适合拉美裔，在我们之前对该种族进行的对照试验中被证明是有效的。多模式联系(即，面对面，电话咨询， 和邮寄的印刷材料)将用于在怀孕期间(怀孕12周到分娩)一直到产后(产后6周到产后6个月)提供干预；随访将持续到产后1年。干预的目标是实现医学研究所关于GWG和产后减肥的指南；ACOG通过增加步行和发展更积极的生活方式来进行体力活动的指南；以及通过遵循美国糖尿病协会的指南通过平衡的健康饮食减少总卡路里。干预借鉴了社会认知理论和跨理论模型，包括为伴侣和/或家庭提供支持的策略，以解决特定的社会、文化和 服务不足的西班牙裔妇女面临的经济挑战。合规性的衡量标准将包括活动图和西班牙裔食物频率问卷。拟议的项目基于调查团队在对拉美裔孕妇的运动干预(R01 DK074876)和低收入拉美裔2型糖尿病患者的饮食干预(R18 DK0658850)进行随机对照试验方面的专业知识，并可以很容易地转化为服务不足和少数族裔人群的临床实践。

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.