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

准备：孕前减肥干预的随机试验

• 批准号: 9339405
• 负责人: ERIN S LEBLANC
• 金额: $ 11.81万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 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/9339405
• 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; 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' s Group; Work; aged; base; care systems; critical period; diet and exercise; efficacy testing; exercise intensity; experience; fruits and vegetables; gestational weight gain; group intervention; healthy weight; improved; in utero; insight; interest; intervention program; next generation; offspring; pregnancy hypertension; pregnant; prenatal; prevent; primary outcome; programs; randomized trial; reproductive; response; satisfaction; saturated fat; secondary outcome; successful intervention; therapy design; therapy development; treatment as usual; web site; weight loss intervention

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）：在美国，几乎一半的孕妇开始怀孕时肥胖或超重，超过一半的孕妇经历过妊娠期体重过度增加。这些妇女患妊娠期糖尿病、妊娠期高血压和先兆子痫等并发症的风险增加。肥胖妇女在分娩时需要更多的手术干预，产后感染也更多。越来越多的证据表明，母亲在怀孕开始时的体重以及怀孕期间的超重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有关。我们已经成功地帮助妇女避免在怀孕期间体重过度增加，并在怀孕的头三个月开始实施一项计划。然而，器官发生和代谢程序在妊娠早期开始，远早于第一次产前检查。因此，等待增加母亲的体重、体力活动和饮食不是最佳的。我们建议进行一项随机临床试验，以评估一项全面的孕前计划，以帮助肥胖和超重妇女改善饮食和体育活动习惯，并在怀孕前减肥，并在怀孕期间不增加体重。由于考虑怀孕的女性对她们的时间有很多要求，我们在成功的远程干预后进行了干预，但经常接触干预。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，并访问支持性网站。这项研究将在一个综合健康计划，凯撒永久西北（KPNW）进行。KPNW的一个随机抽样的妇女对一个孕前生活方式计划表示了高度的兴趣。我们将使用KPNW广泛的电子医疗记录来识别怀孕可能性高的女性，并邀请她们参与。我们将实施一项随机临床试验，以测试个性化体重管理干预与常规护理对照，用于计划在未来两年怀孕的BMI e 28的女性。我们认为，通过改善母亲的体重、饮食质量和活动水平，干预将导致后代的出生体重低于对照母亲后代的出生体重（接近国家标准）。我们相信，通过电话和网站提供的干预，将是高度可接受的育龄妇女。如果我们证明帮助女性以更健康的体重开始怀孕可以改善她们自己和孩子的健康，那么这个计划可以在各种环境中迅速实施，并且可能具有减少肥胖和改善未来几代人公共健康的巨大潜力。