Appropriate Gestational Weight Gain in Overweight/Obese Women

超重/肥胖女性妊娠期体重适当增加

• 批准号: 8618912
• 负责人: ASSIAMIRA FERRARA
• 金额: $ 65.53万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-03-01 至 2018-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8618912
• 关键词: Adoption; African American; Age; Asians; Behavior; Birth; Blinded; Body Weights and Measures; Body fat; Body mass index; C-Peptide; California; Calories; Caring; Caucasians; Caucasoid Race; Child; Computerized Medical Record; Conceptions; Counseling; Diet; Enrollment; Fatty acid glycerol esters; Gestational Age; Glucose; Goals; Health Planning; Health system; Healthcare Systems; Hispanics; Housing; Human Resources; Infant; Institute of Medicine (U.S.); Insulin; Integrated Health Care Systems; Intervention; Kilogram; Length; Leptin; Lipids; Measurement; Mediating; Medical; Obesity; Overweight; Participant; Perinatal; Persons; Physical activity; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Provider; Randomized; Randomized Controlled Clinical Trials; Sampling; Techniques; Telephone; Training; Translations; Umbilical Cord Blood; Weight; Weight Gain; Woman; adiponectin; arm; cost effectiveness; design; infant monitoring; lifestyle intervention; motivational enhancement therapy; obesity prevention; obesity risk; prevent; primary outcome; programs; public health relevance; secondary outcome; treatment as usual

DESCRIPTION (provided by applicant): Preventing excessive gestional weight gain in overweight and obese women has the potential to reduce women's risk of obesity, as well as the risk of obesity in their children. Within the Kaiser Permanente Northern California (KPNC) health system, we propose a randomized controlled clinical trial of diet and physical activity (PA) to help overweight/obese pregnant women achieve appropriate gestational weight gain (GWG). Participants will be randomly assigned to a lifestyle intervention or usual medical care (200 women in each arm; 25% White, 25% African Americans, 25% Asians and 25% Hispanic). The sample will be selected from among women with body weight measured by a KPNC provider no more than 12 months prior to conception. Women will be enrolled at 10 wks of pregnancy. The intervention will begin at 12 wks. It will be delivered via 2 in-person counseling sessions and 11 telephone contacts with study dieticians trained in motivational interviewing techniques who are housed at the KPNC Perinatal Center. Cost-effectiveness analyses will be performed. The intervention will be designed and evaluated for possible translation and adoption by the health care system. Women and their infants will be followed for 12-m after delivery. Study measurements, assessed by trained study personnel blinded of treatment assignment, will be collected at 10-wks and 32-wks of pregnancy, at delivery and at 6-m and 12-m postpartum. Infant measurements will take place at birth and at 6- m and 12-m of age. The PRIMARY AIM is to help overweight/obese pregnant women achieve appropriate total gestional weight gain according to their prepregnancy BMI and weeks of pregnancy, as recommended by the Institute of Medicine (IOM). Primary outcomes will be the proportion of women with appropriate Total GWG and the Rate of Maternal GWG. The secondary outcome will be the proportion of infants with appropriate for gestational age (AGA) birthweight. SECONDARY AIMS include assessing whether women assigned to the lifestyle intervention, as compared to usual care, have: a) more favorable changes in the percent of calories from fat, minutes of PA per week and body fat mass during pregnancy; b) more favorable changes in weight and body fat mass at 12-m postpartum; c) have infants with more appropriate anthropometrics at 12-m. EXPLORATORY AIMS include exploration of the associations between the GWG intervention and women's cardiometabolic profiles and infants' cardiometabolic profiles and body fat mass. Exploring possible associations of GWG management with adiposity and cardiometabolic profiles will provide valuable information for obesity prevention efforts. The potential adoption of a GWG management program by an integrated health care system represents a unique opportunity for interrupting the vicious cycle of obesity and cardiometabolic complications.

描述（由申请人提供）：预防超重和肥胖妇女过度体重增加，有可能降低妇女的肥胖风险，以及子女肥胖的风险。在Kaiser Permanente北加州（KPNC）卫生系统中，我们提出了一项饮食和体育锻炼的随机对照临床试验（PA） 为了帮助超重/肥胖的孕妇获得适当的妊娠体重增加（GWG）。参与者将被随机分配到生活方式干预或通常的医疗服务（每只手臂中有200名妇女； 25％的白人，25％的非洲裔美国人，25％的亚洲人和25％的西班牙裔）。样本将从受孕前不超过12个月的KPNC提供者测量的女性中选择。妇女将入学10周的怀孕。干预措施将在12周开始。它将通过2次面对面的咨询会议和11个电话联系，并与接受激励访谈技术培训的学习营养师进行了联系，他们在KPNC Perinatal Center中被安置。将进行成本效益分析。该干预措施将经过设计和评估，以通过医疗保健系统的翻译和采用。分娩后，妇女及其婴儿将被追踪12米。通过培训的研究人员评估治疗分配的研究人员将在10周和32周的怀孕，分娩时以及产后6米和12米处收集。婴儿测量将在出生时，6 m和12 m的年龄进行。主要目的是帮助超重/肥胖的孕妇根据医学研究所（IOM）的建议，根据其孕前BMI和怀孕数周的妊娠BMI和数周的怀孕数周实现适当的总体体重增加。主要结果将是适当的GWG和母体GWG率的妇女的比例。次要结果将是适合胎龄（AGA）出生体重的婴儿的比例。次要目的包括评估与通常的护理相比，分配给生活方式干预的妇女是否具有：a）脂肪中卡路里百分比的更大变化，每周的PA分钟，每周和怀孕期间的体内脂肪质量； b）产后12米的体重和体内脂肪质量的更有利变化； c）患有12米处更合适的拟人化的婴儿。探索目的包括探索GWG干预与女性心脏代谢概况与婴儿心脏代谢概况和体内脂肪量之间的关联。探索GWG管理与肥胖和心脏代谢概况的可能关联将为肥胖预防工作提供有价值的信息。综合医疗保健系统对GWG管理计划的潜在采用代表了中断肥胖和心脏代谢并发症的恶性循环的独特机会。