Randomized Trial of a Postpartum Diabetes Prevention Program for Hispanic Women

西班牙裔妇女产后糖尿病预防计划的随机试验

• 批准号: 8874207
• 负责人: LISA CHASAN-TABER
• 金额: $ 50.79万
• 依托单位: UNIVERSITY OF MASSACHUSETTS AMHERST
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-15 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8874207
• 关键词: Address; Adherence; Adoption; Adult; Albumins; American; American College of Obstetricians and Gynecologists; Area; Behavior; Biological Markers; Blood Pressure; Body Weight decreased; C-reactive protein; Cardiovascular Diseases; Centers for Disease Control and Prevention (U.S.); Cholesterol; Consumption; Counseling; Creatinine; Diabetes Mellitus; Diagnosis; Diastolic blood pressure; Diet; Dietary Intervention; Economics; Energy Intake; Epidemic; Exercise; Fasting; Fatty acid glycerol esters; Food; Gestational Diabetes; Glucose; Glycosylated hemoglobin A; Goals; Guidelines; Health; High Density Lipoprotein Cholesterol; Hispanics; Homeostasis; Institute of Medicine (U.S.); Insulin; Insulin Resistance; Intake; Intervention; LDL Cholesterol Lipoproteins; Leptin; Life Style; Low income; Maintenance; Measurement; Measures; Minority Groups; Modeling; Modification; Non-Insulin-Dependent Diabetes Mellitus; Normal Range; Not Hispanic or Latino; Obesity; Overweight; Participant; Pathway interactions; Persons; Physical activity; Population; Postpartum Period; Postpartum Women; Prediabetes syndrome; Pregnancy; Pregnant Women; Prevention; Printing; Randomized; Randomized Controlled Trials; Recipe; Recording of previous events; Recruitment Activity; Reporting; Risk; Risk Factors; TNF gene; Telephone; Testing; Translating; Triglycerides; Underrepresented Minority; Walking; Weight; Woman; adiponectin; alpha-Fetoproteins; base; blood lipid; cardiovascular risk factor; clinical practice; control trial; cost; diabetes prevention program; diabetes risk; efficacy testing; fast food; fruits and vegetables; glucose tolerance; health disparity; high risk; impaired glucose tolerance; indexing; lifestyle intervention; programs; randomized trial; screening; sedentary; social; social cognitive theory; sugar; sweetened beverage

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.

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，西班牙裔的发病率一直较高。在被诊断患有妊娠期糖尿病（GDM）的西班牙裔女性中，50%的人将在指数妊娠的5年内发展为2型糖尿病。尽管在葡萄糖耐量受损的成年人中进行的随机对照试验表明，饮食和体力活动可以降低2型糖尿病的风险，但这些计划尚未在高危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上改良的、个性化定制的生活方式干预的有效性，以减少有妊娠期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以下方面的影响：1）产后体重减轻，2）与胰岛素抵抗相关的生物标志物（即，葡萄糖、胰岛素、HbA 1c、瘦素、TNF-α、HOMA、AUCgluc、脂联素），3）其它心血管危险因素（即，血脂、血压、CRP、胎球蛋白 A，白蛋白与肌酸酐比率），和4）采用和维持与体重减轻和预防糖尿病风险相关的产后行为（即，体力活动、饮食）。Eligibe西班牙裔女性将在常规GDM筛查后招募，并随机分配至生活方式干预组（n=150）或健康与健康（对照）干预组（n=150）。干预将基于我们对西班牙裔美国人的有效运动和饮食干预（R 01 NR 011295; WIC共同途径）。多模式接触（即，面对面、电话咨询和邮寄印刷材料）将用于从随机化（妊娠29周）至产后12个月提供干预。干预的目标是实现医学研究所产后减肥指南;美国妇产科医师学院体力活动指南;以及美国糖尿病协会饮食指南。干预借鉴社会认知理论和跨理论模型，并解决了具体的社会，文化，经济和物理环境的挑战所面临的服务不足的西班牙裔妇女。坚持的措施将包括加速计和饮食召回。