Lifestyle Interventions in Overweight and Obese Pregnant Women

超重和肥胖孕妇的生活方式干预

基本信息

批准号：
8247963
负责人：
DYMPNA GALLAGHER
金额：
$ 81.53万
依托单位：
ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-19 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8247963
关键词：
Adipose tissue Adult Age Anthropometry Behavior Behavioral Biological Process Birth Blood Body Weight CCL2 gene Catchment Area Child Cost Analysis Counseling Data Dietary intake Dropout Enrollment Environment Fatty acid glycerol esters Funding Future Generations Glucose Guidelines High Density Lipoprotein Cholesterol Hospitals Infant Inflammatory Institute of Medicine (U.S.)Insulin Internet Intervention Intramuscular Knowledge Lead Leptin Life Lipids Magnetic Resonance Imaging Measurement Measures Metabolic Mother-Child Relations Mothers Non-Insulin-Dependent Diabetes Mellitus Obesity Outcome Overweight Participant Physical activity Physicians Plasma Plasminogen Activator Inhibitor 1 Pregnancy Pregnant Women Prevalence Professional counselor Public Health Quality of life Questionnaires Randomized Controlled Trials Recommendation Risk Risk Factors Secondary to Socioeconomic Status Telephone Visceral Visit Weight Weight Gain Whole Body Plethysmography Woman adiponectin arm cohort cost effective group counseling improved in utero infant monitoring inflammatory marker lifestyle intervention low density lipoprotein triglyceride nutrition offspring pregnant prevent primary outcome reproductive subcutaneous treatment as usual

项目摘要

DESCRIPTION (provided by applicant): A randomized controlled trial is proposed to study the effect, in a cohort of racially and ethnically diverse group of overweight and obese pregnant women, of an Intensive Lifestyle Intervention (ILI) compared to Usual Care (UC) on gestational weight gain (GWG), infant fatness, and mothers' post-delivery weight retention. Women in the ILI arm will receive intensive counseling during pregnancy and group counseling after delivery regarding behavior, nutrition, and physical activity change. Visits to counselors will be weekly and additional telephone and internet contacts will occur. The mothers' will be assessed at 14 and 36 weeks of pregnancy and at 12 weeks and 52 weeks post-delivery. The measurements will be anthropometry, whole body MRI, EchoMRI, and whole body plethysmography (BodPod). The infants' measurements will be anthropometry, whole body MRI, EchoMRI, and whole body plethysmography (PeaPod) for fatness 12 weeks and 52 weeks. Mothers and children will have cardio-metabolic risk factors measured in plasma. Data will be collected regarding mothers' dietary intake and physical activity (questionnaires and accelerometry) to assist in counseling. Other data to be collected include questionnaires on quality of life, socio-economic status. Careful record will be kept of expenses in providing the ILI, so that cost analysis of the intervention can be calculated. The study is powered on the primary outcome, fatness of the infants at birth. We require 180 participants to attain appropriate power. We will enroll 210 so as to allow for some dropouts along the way. Each mother will be followed during pregnancy and for a year post delivery. Each infant will be followed for a year after birth. We have the ability o continue to follow these participants if further funding is forthcoming, as they are all local to or hospital's catchment area and our own physicians. If aims are achieved, namely that both children and mothers profit from the intervention, there should be a paradigm shift in how overweight pregnant women are treated. At present, there is a dearth of behavioral advice and intervention relating to GWG and physical activity provided to these women. Positive results from our study would provide evidence for ILI preventative intervention. PUBLIC HEALTH RELEVANCE: The prevalence of overweight and obesity in reproductive age US women is extremely high. These women when pregnant tend to gain higher than the recommended GWG, produce disproportionally fat babies, and retain much of the GWG post-partum. It is unknown whether maintaining GWG within the new lOM guidelines will produce leaner babies who have less risk of becoming obese adults, and will lead to less retention of GWG in women. A trial demonstrating these outcomes could lead to public health recommendations.

描述（由申请人提供）：拟进行一项随机对照试验，以研究在不同种族和民族的超重和肥胖孕妇群体中，强化生活方式干预（ILI）与常规护理（UC）相比的效果妊娠期体重增加 (GWG)、婴儿肥胖和母亲产后体重保持。 ILI 组的女性将在怀孕期间接受强化咨询，并在分娩后接受有关行为、营养和身体活动变化的团体咨询。每周都会拜访辅导员，并会进行额外的电话和互联网联系。母亲将在怀孕 14 周和 36 周以及产后 12 周和 52 周时接受评估。测量将包括人体测量学、全身 MRI、EchoMRI 和全身体积描记法 (BodPod)。对婴儿 12 周和 52 周的肥胖情况进行人体测量、全身 MRI、EchoMRI 和全身体积描记法 (PeaPod) 测量。母亲和儿童将在血浆中测量心脏代谢危险因素。将收集有关母亲饮食摄入量和身体活动的数据（问卷和加速度测量）以协助咨询。其他要收集的数据包括有关生活质量、社会经济状况的调查问卷。将仔细记录提供 ILI 的费用，以便计算干预的成本分析。该研究的主要结果是婴儿出生时的肥胖程度。我们需要 180 名参与者才能获得适当的权力。我们将报名 210 人，以便允许沿途出现一些中途退出的情况。每位母亲在怀孕期间和产后一年内都会受到跟踪。每个婴儿出生后将被跟踪一年。如果有进一步的资金支持，我们有能力继续跟踪这些参与者，因为他们都是本地人或医院的服务区域以及我们自己的医生。如果目标得以实现，即儿童和母亲都从干预中受益，那么超重孕妇的治疗方式应该发生范式转变。目前，缺乏向这些女性提供的与 GWG 和身体活动相关的行为建议和干预措施。我们研究的积极结果将为流感样疾病预防干预提供证据。公共卫生相关性：美国育龄妇女超重和肥胖的患病率极高。这些女性在怀孕时的体重增长往往高于建议的体重增长，产下的婴儿体重不成比例，并且在产后保留了大部分体重增长。目前尚不清楚将 GWG 维持在新的 lOM 指南范围内是否会产生更瘦的婴儿，从而降低成年肥胖的风险，并导致女性 GWG 保留率降低。证明这些结果的试验可能会产生公共卫生建议。