Lifestyle Interventions in Overweight and Obese Pregnant Women

描述（由申请人提供）：提出一项随机对照试验，研究在一组不同种族和民族的超重和肥胖孕妇中，与常规护理（UC）相比，强化生活方式干预（ILI）对妊娠期体重增加（GWG）、婴儿肥胖和母亲产后体重保持的影响。ILI组的妇女将在怀孕期间接受强化咨询，并在分娩后接受关于行为、营养和身体活动变化的小组咨询。每周拜访辅导员，并进行额外的电话和互联网联系。母亲们将在怀孕14周和36周以及分娩后12周和52周进行评估。测量将包括人体测量、全身MRI、EchoMRI和全身体积脉搏图（BodPod）。婴儿的测量将是人体测量、全身MRI、EchoMRI和全身体积脉搏图（PeaPod），用于12周和52周的肥胖。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和身体活动的数据（问卷调查和加速度计），以协助咨询。收集的其他数据包括关于生活质量、社会经济地位的调查表。提供ILI的费用将被仔细记录，以便计算干预措施的成本分析。这项研究的主要结果是婴儿出生时的肥胖。我们需要180个参与者来获得适当的权力。我们将招收210人

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.