Randomized Trial of a Postpartum Diabetes Prevention Program for Hispanic Women

描述（由申请人提供）：糖尿病和肥胖症在美国已经达到流行病的比例，与非西班牙裔白人相比，西班牙裔白人的发病率一直较高。在诊断为妊娠期糖尿病（GDM）的西班牙裔妇女中，50%将在第一次妊娠的5年内继续发展为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，饮食和体育活动可以降低患2型糖尿病的风险，但此类项目尚未在高风险的产后妇女中进行过测试。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，以降低怀孕期间有糖耐量异常史的西班牙裔产后妇女患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对1)产后体重减轻的影响，2)与胰岛素抵抗相关的生物标志物（即葡萄糖、胰岛素、HbA1c、瘦素、TNF-、HOMA、AUCgluc、脂联素），3)其他心血管危险因素（即血脂、血压、CRP、胎蛋白）

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.