Randomized Trial of a Postpartum Diabetes Prevention Program for Hispanic Women

描述(申请人提供)：糖尿病和肥胖症在美国已经达到流行的程度，与非西班牙裔白人相比，西班牙裔的发病率一直较高。在被诊断为妊娠期糖尿病(GDM)的西班牙裔女性中，50%的人会在怀孕5年内发展为2型糖尿病。尽管在糖耐量受损的成年人中进行的随机对照试验表明，饮食和体力活动降低了患2型糖尿病的风险，但此类计划尚未在产后高危女性中进行测试。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，以降低在怀孕期间有异常糖耐量史的产后西班牙裔妇女患2型糖尿病和心血管疾病的风险因素。具体目的是评估干预措施对以下方面的影响：1)产后体重减轻；2)与胰岛素抵抗有关的生物标志物(即葡萄糖、胰岛素、糖化血红蛋白、瘦素、肿瘤坏死因子、胰岛素抵抗指数、糖化血红蛋白、糖化血红蛋白、脂联素)；3)其他心血管危险因素(如血脂、血压、C反应蛋白、胎儿蛋白) A)白蛋白与肌酐的比率)，以及4)采用和维持与减肥和预防糖尿病风险有关的产后行为(例如，体力活动、饮食)。Eligibe拉美裔妇女将在常规GDM筛查后被招募，并随机分配到生活方式干预组(n=150)或对照健康与健康(对照)干预组(n=150)。该干预将基于我们对拉美裔美国人的有效运动和饮食干预(R01NR011295；WIC Common Path)。多模式接触(即面对面、电话咨询和邮寄打印材料)将用于提供从随机化(怀孕29周)到产后12个月的干预。干预的目标是实现医学院产后减肥指南；美国妇产科医学院体力活动指南；以及美国糖尿病协会饮食指南。这项干预措施借鉴了社会认知理论和跨理论模型，解决了服务不足的西班牙裔妇女面临的具体社会、文化、经济和物质环境挑战。遵守的衡量标准将包括加速计和饮食召回。

DESCRIPTION (provided by applicant): Diabetes and obesity have reached epidemic proportions in the U.S. with rates consistently higher among Hispanic as compared to non-Hispanic whites. Among Hispanic women diagnosed with gestational diabetes mellitus (GDM), 50% will go on to develop type 2 diabetes within 5 years of the index pregnancy. Although randomized controlled trials among adults with impaired glucose tolerance have shown that diet and physical activity reduce the risk of type 2 diabetes, such programs have not been tested in high risk postpartum women. The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention o reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy. Specific aims are to evaluate the impact of the intervention on 1) postpartum weight loss, 2) biomarkers associated with insulin resistance (i.e., glucose, insulin, HbA1c, leptin, TNF-, HOMA, AUCgluc, adiponectin), 3) other cardiovascular risk factors (i.e., blood lipids, blood pressure, CRP, fetuin A, albumin-to-creatinine ratio), and 4) the adoption and maintenance of postpartum behaviors associated with weight loss and prevention of diabetes risk (i.e., physical activity, diet). Eligibe Hispanic women will be recruited after routine GDM screening and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) intervention (n=150). The intervention will be based on our efficacious exercise and dietary interventions for Hispanics (R01NR011295; WIC Common Pathways). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention from randomization (29 wks gestation) to 12 months postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss; American College of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific social, cultural, economic, and physical environmental challenges faced by underserved Hispanic women. Measures of adherence will include accelerometers and dietary recalls.