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（由申请人提供）：妊娠糖尿病 (GDM) 与多种急性孕产妇风险相关，包括先兆子痫、剖腹产、引产和早产，以及 2 型糖尿病、代谢综合征和心血管疾病的长期风险。患有 GDM 的女性更有可能表现出胰岛素抵抗的特征，这是 2 型糖尿病和心血管疾病 (CVD) 的强烈先兆。宫内暴露于 GDM 会增加新生儿健康风险，包括胎儿死亡、巨大儿、产伤和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，并增加了相关的孕产妇/胎儿健康风险。流行病学和减肥手术研究的初步数据表明，怀孕前减轻体重可以预防 GDM 和相关母婴并发症的发生。我们的初步研究表明，在怀孕前招募女性并促进受孕前显着减肥是可行的。然而，尚未进行过全面的试验来测试孕前母亲生活方式干预对减轻体重和预防 GDM 复发的影响。本研究的主要目的是确定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。这项两中心试验拟招募 350 名有 GDM 病史且计划在未来 1-2​​ 年内再次怀孕的超重/肥胖女性。女性将在现场被随机分为为期 16 周的综合孕前生活方式减肥干预组（持续治疗直至受孕）或教育对照组。评估将在怀孕前（研究开始时、4 个月后以及受孕前每季度短暂访视时）、怀孕期间（妊娠 26 周时）和产后 6 周分娩时进行。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，拟议的生活方式干预措施可以将目前的治疗实践转向怀孕期间，并提供一种“基于证据的”立即可用的治疗方法，旨在优化生殖结果并预防每年超过 200,000 名被诊断患有 GDM 的美国女性的 GDM 和相关慢性疾病。这项研究也具有创新性，因为目前还没有随机对照试验评估孕前生活方式干预对预防 GDM 的影响。拟议的研究以预防为重点，将直接挑战目前 GDM 的传统方法（侧重于怀孕期间的早期识别和治疗），并将努力转向孕前阶段。