Prevention of gestational diabetes through lifestyle modification before pregnancy

通过孕前改变生活方式预防妊娠糖尿病

• 批准号: 9037455
• 负责人: Suzanne Phelan
• 金额: $ 60.45万
• 依托单位: CALIFORNIA POLY STATE U SAN LUIS OBISPO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-18 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9037455
• 关键词: Acute; Admission activity; Affect; Behavior Therapy; Biological Markers; Birth; Birth trauma; Blood Pressure; Body Weight; Body Weight decreased; C-reactive protein; Calories; Cardiovascular Diseases; Cesarean section; Cessation of life; Chronic; Conceptions; Control Groups; Development; Diabetes Mellitus; Diagnosis; Diet; Early identification; Early treatment; Eating; Enrollment; Epidemiologic Studies; Exposure to; Fatty acid glycerol esters; Gestational Diabetes; Health; Healthcare; Hispanics; Hyperglycemia; Icterus; Infant; Infant Health; Insulin; Insulin Resistance; Intervention; Kidney Diseases; Length; Leptin; Life; Life Experience; Life Style; Link; Lipids; Maternal Health; Maternal Physiology; Mediator of activation protein; Metabolic; Metabolic Diseases; Metabolic syndrome; Moderate Activity; Mothers; Neonatal; Non-Insulin-Dependent Diabetes Mellitus; Nurseries; Obesity; Outcome; Overweight; Participant; Physical activity; Postpartum Period; Pre-Eclampsia; Pregnancy; Pregnancy in Diabetics; Premature Birth; Prevalence; Prevention; Provider; Randomized; Randomized Controlled Trials; Recording of previous events; Recruitment Activity; Recurrence; Research; Research Project Grants; Risk; Site; TNF gene; Testing; United States National Institutes of Health; Uterus; Visit; Weight; Woman; adiponectin; bariatric surgery; behavior change; cardiovascular disorder risk; congenital anomaly; cost; epidemiologic data; evidence base; fast food; fasting glucose; fetal; gestational weight gain; improved; innovation; lifestyle intervention; meetings; neonate; perinatal complications; perinatal health; perinatal outcomes; pregnant; prenatal; prevent; programs; public health relevance; reproductive; respiratory distress syndrome; success; targeted treatment; weight loss intervention

 DESCRIPTION (provided by applicant): Gestational diabetes mellitus (GDM) is linked with several acute maternal risks, including preeclampsia, caesarean sections, induced deliveries, and pre-term labor, and long-term risks of type 2 diabetes, metabolic syndrome, and cardiovascular disease. Women with GDM are more likely to display features of insulin resistance - a strong precursor to type 2 diabetes and cardiovascular disease (CVD). Intrauterine exposure to GDM raises neonatal health risks, including fetal demise, macrosomia, and birth trauma and long-term risk of metabolic disease. GDM recurrence is also common, affecting 40- 73% of women overall, and augments associated maternal/fetal health risks. Preliminary data from epidemiologic and bariatric surgery studies suggest that reducing body weight before pregnancy can prevent development of GDM and associated maternal/fetal complications. Our preliminary research suggested that it was feasible to recruit women before pregnancy and promote significant weight loss prior to conception. However, a full scale trial to test the effects of maternal lifestyle intervention before pregnancy to reduce body weight and prevent GDM recurrence has never been conducted. The principal aim of this study is to determine whether a lifestyle intervention to reduce body weight before pregnancy can reduce GDM recurrence and improve biomarkers of insulin resistance and cardiovascular disease. This two-site trial proposes to recruit 350 overweight/obese women with previous histories of GDM who plan to have another pregnancy in the next 1-2 years. Women will be randomized within site to a 16-week comprehensive pre-pregnancy lifestyle weight loss intervention (with ongoing treatment until conception) or an educational control group. Assessments will occur before pregnancy (at study entry, after 4 months, and at brief quarterly visits until conception), during pregnancy (at 26 weeks gestation) and at delivery at 6 weeks postpartum. Secondary aims will examine treatment-related reductions in prenatal and perinatal complications and changes in pre- pregnancy weight, eating, and activity. If found effective, the proposed lifestyle interventio could shift current treatment practices towards the interconception period and provide an "evidence based" immediately useable therapy targeted to optimize reproductive outcomes and prevent GDM and associated chronic conditions in the more than 200,000 US women diagnosed with GDM each year. The study is also innovative, as there have been no randomized controlled trials evaluating the effects of a lifestyle intervention delivered before pregnancy to prevent GDM. With a focus on prevention, the proposed study will directly challenge the current conventional approach to GDM - which focuses on early identification and treatment during pregnancy - and shift efforts towards the preconception period.

 描述（由适用提供）：妊娠糖尿病（GDM）与几种急性产妇风险联系在一起，包括前峰，剖腹产，诱导的送货和前劳动，以及2型糖尿病，代谢综合征和心血管疾病的长期风险。具有GDM的女性更有可能显示胰岛素抵抗的特征 - 2型糖尿病和心血管疾病（CVD）的强大先驱。内脏暴露于GDM会增加新生儿健康风险，包括胎儿灭亡，大疾病和出生创伤以及代谢性疾病的长期风险。 GDM复发也很常见，影响了40-73％的女性总体，并增加了相关的母亲/胎儿健康风险。来自流行病学和减肥手术研究的初步数据表明，减少妊娠前体重可以防止GDM和相关的母亲/胎儿并发症的发展。我们的初步研究表明，在怀孕前招募妇女并在概念之前促进体重减轻是可行的。但是，一项全尺度试验以测试孕妇生活方式干预前怀孕前的影响，以减轻体重并预防GDM复发。这项研究的主要目的是确定在怀孕前减轻体重的生活方式干预是否可以减少GDM复发并改善胰岛素抵抗和心血管疾病的生物标志物。这项旨在招募350名超重/肥胖妇女具有GDM史的两场试验提案，她计划在未来1 - 2年内再次怀孕。妇女将在现场内随机分配为16周的综合孕前生活方式减肥干预措施（持续治疗直到概念）或一个教育对照组。评估将在怀孕之前（研究入学，4个月后以及短暂的季度访问，直到概念），在怀孕期间（妊娠26周）和产后6周的交货。次要目标将检查与治疗相关的产前和围产期并发症的减少以及孕前体重，饮食和活动的变化。如果发现有效，拟议的生活方式介入可能会将当前的治疗方法转移到概念期，并立即提供“基于证据的”可用治疗，该治疗旨在优化生殖结果，并防止每年被诊断为GDM的200,000多名美国妇女中GDM和相关的慢性病。这项研究也是创新的，因为没有随机对照试验来评估怀孕前的生活方式干预措施以防止GDM的影响。旨在预防预防，拟议的研究将直接挑战当前的GDM传统方法，该方法侧重于怀孕期间的早期识别和治疗 - 并将努力转移到了先前的时期。