PREPARE: A randomized trial of a pre-pregnancy weight loss intervention

准备：孕前减肥干预的随机试验

基本信息

批准号：
8695004
负责人：
Victor J Stevens
金额：
$ 73.61万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-07-01 至 2018-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8695004
关键词：
Address Adopted Advisory Committees Birth Birth Weight Body Weight decreased Body mass index Child Computerized Medical Record Conceptions Counseling Diet Dietary intake Eating Electronics Energy Intake Epidemic Event Exercise Face Family First Pregnancy Trimester Future Generations Gestational Diabetes Goals Habits Health Health Planning Healthcare Infection Institute of Medicine (U.S.)Intervention Intervention Studies Lead Life Life Style Longevity Low Birth Weight Infant Managed Care Medical Metabolic Modeling Mothers Obesity Observational Study Online Systems Organogenesis Outcome Overweight Participant Pattern Perinatal Exposure Persons Physical activity Planned Pregnancy Postpartum Period Pre-Eclampsia Pregnancy Pregnancy Trimesters Pregnant Women Proxy Public Health Randomized Randomized Clinical Trials Recommendation Research Risk Sampling Schedule Strategic Planning System Telephone Testing Time United States National Institutes of Health Visit Weight Weight Gain Weight maintenance regimen Woman Women&apos s Group Work aged base care systems critical period diet and exercise efficacy testing experience fruits and vegetables group intervention improved in utero insight interest intervention program next generation offspring pregnancy hypertension pregnant prenatal prevent primary outcome programs public health relevance randomized trial reproductive response satisfaction saturated fat secondary outcome successful intervention therapy design therapy development treatment as usual web site weight loss intervention

项目摘要

DESCRIPTION (provided by applicant): Almost half of pregnant women in the US begin their pregnancies obese or overweight and more than half experience excessive gestational weight gain. These women are at increased risk for complications such as gestational diabetes, gestational hypertension, and pre-eclampsia. Obese women require more operative interventions at delivery and suffer more postpartum infections. Growing evidence suggests that a mother's weight at pregnancy onset, and excessive weight during pregnancy, are associated with an increased risk that her child will become obese and face obesity-related health issues. We have successfully helped women avoid excessive weight gain during pregnancy with a program started in the first trimester. However, organogenesis and metabolic programming begin early in the first trimester, well before the first prenatal visit. Therefore, waiting to addess mothers' weight, physical activity, and diet is not optimal. We propose to conduct a randomized clinical trial to evaluate a comprehensive pre-conception program to help obese and overweight women improve diet and physical activity habits and lose weight prior to becoming pregnant, and to not gain excessive weight during pregnancy. Because women considering pregnancy have many demands on their time, we modeled our intervention after successful remote, yet frequent contact interventions.1-3 We will use face-to-face counseling with a personal health coach followed by 24 months of frequent phone counseling with the same coach and access to a supportive website. The study will be conducted in an integrated health plan, Kaiser Permanente Northwest (KPNW). A random sample of women in KPNW have expressed high interest in a preconception lifestyle program. We will use KPNW's extensive electronic medical records to identify women with a high likelihood of pregnancy, and invite them to participate. We will implement a randomized clinical trial to test a personalized weight management intervention in comparison to usual care control for women with a BMI e 28 who are planning a pregnancy in the next two years. We believe that by improving mothers' weights, diet quality, and activity levels, the intervention will lead to offspring with lower birth weight (closer to national norms) compared to birth weights above norms in offspring of control mothers. We believe the intervention, delivered via telephone and website, will be highly acceptable to reproductive aged women. If we demonstrate that helping women start pregnancy at a healthier weight improves their own health and that of their children, this program could be quickly implemented in a variety of settings, and could have enormous potential to reduce obesity and improve public health for generations to come.

描述（由申请人提供）：美国几乎一半的孕妇开始怀孕肥胖或超重，一半以上的妊娠体重增加过多。这些妇女面临妊娠糖尿病，妊娠高血压和前宾夕法尼亚之前的并发症的风险增加。肥胖妇女在分娩时需要进行更多的手术干预措施，并遭受更多产后感染。越来越多的证据表明，母亲在怀孕发作时的体重和怀孕期间的体重过多与她的孩子变得肥胖并面临与肥胖相关的健康问题的风险增加。我们已经成功地帮助女性避免了在孕早期开始的一项计划期间怀孕期间过度体重增加。但是，在第一次造成产前访问之前的前三个月初期，器官发生和代谢编程开始。因此，等待母亲的体重，体育锻炼和饮食不是最佳的。我们建议进行一项随机临床试验，以评估一项全面的概念前计划，以帮助肥胖和超重女性改善饮食和体育锻炼习惯，并在怀孕前减肥，并在怀孕期间不体重过多。由于考虑怀孕的妇女对时间有很多要求，因此我们在成功的遥远但频繁的接触干预措施后对干预进行了建模。1-3我们将与个人健康教练进行面对面的咨询，然后与同一教练进行24个月的频繁电话咨询，并访问支持网站。该研究将在综合健康计划中进行，Kaiser Permanente Northwest（KPNW）。 KPNW中的一个随机样本对一个先入为主的生活方式计划表达了很高的兴趣。我们将使用KPNW的广泛电子病历来确定怀孕可能性很大的女性，并邀请她们参加。与针对未来两年中计划怀孕的女性相比，我们将实施一项随机临床试验，以测试个性化的体重管理干预措施。我们认为，通过改善母亲的体重，饮食质量和活动水平，与控制母亲的后代高于规范相比，干预措施将导致出生体重较低（接近国家规范）的后代。我们认为，通过电话和网站提供的干预措施对于生殖老年妇女来说将是高度可接受的。如果我们证明帮助妇女以更健康的体重开始怀孕可以改善自己的健康和孩子的健康，那么该计划可以在各种环境中迅速实施，并且可能具有巨大的潜力来减少肥胖和改善未来几代人的公共健康。