Preventing excessive gestational weight gain in obese women

描述（由申请人提供）：怀孕期间低强度的生活方式干预可以防止正常体重妇女妊娠期体重过度增加。然而，防止肥胖妇女妊娠期体重过度增加已被证明更为困难。包括特定卡路里目标处方和均衡营养的强化干预已显示出最大的希望，但是，与非怀孕人群相似，促进持续坚持卡路里处方仍然是一个重大挑战。在非怀孕的多种族人群中，液态代餐产品已被证明能促进坚持卡路里和体重目标。此外，在怀孕期间，它们被用作提高营养充足性的补充剂，并被证明是安全的，并能改善饮食摄入量。然而，到目前为止，还没有研究评估这种方法可以防止怀孕期间体重过度增加。本研究的主要目的是确定多组分生活方式干预，包括怀孕期间的部分膳食替代，是否可以减少超过lOM建议怀孕期间体重增加的肥胖妇女的数量。在这项双中心随机试验中，430名肥胖妇女，其中50%为西班牙裔，将根据地点和种族随机分为部分膳食替代方案的多组分生活方式改变治疗（N=215）或标准治疗（N=215）。治疗将在怀孕期间进行，使用我们以前工作的标准化干预程序。所有妇女将在妊娠早期（10至16周）、妊娠30周、产后6个月和12个月时进行招募和评估，并在分娩时和产后2个月进行人体测量。我们认为该项目意义重大，因为它涉及预防妊娠期体重过度增加及其相关的不良母婴健康后果。这项研究也具有创新性；目前还没有随机对照试验评估行为生活方式干预与部分膳食替代计划对促进多种族肥胖妇女健康体重增加的影响。

DESCRIPTION (provided by applicant): Low-intensity lifestyle interventions during pregnancy can prevent excessive gestational weight gain in normal weight women. However, preventing excessive gestational weight gain in obese women has proven more difficult. Intensive interventions involving prescription of specific calorie goals and balanced nutrition have shown the most promise, but, similar to non-pregnant populations, promoting ongoing adherence to caloric prescription remains a significant challenge. Liquid meal-replacement products have been shown to promote adherence to calorie and weight goals in non-pregnant multiethnic populations. Moreover, they have been used during pregnancy as a supplement to improve nutritional adequacy and shown to be safe and to result in improved dietary intake. However, no study to date has evaluated this approach as a means to prevent excessive weight gain during pregnancy. The principal aim of this study is to determine whether a multi-component lifestyle intervention that incorporates partial meal replacements during pregnancy can reduce the number of obese women who exceed the lOM recommendations for weight gain during pregnancy. In this two-site randomized trial, 430 obese women, 50% Hispanic, will be randomized within site and ethnicity into either a multi-component lifestyle modification treatment with partial meal replacement program (N=215) or standard care (N=215). Treatment will occur during pregnancy, using standardized intervention procedures from our previous work. All women will be recruited and assessed early in pregnancy (between 10 and 16 weeks), at 30 weeks gestation, and at 6 months, and 12 months postpartum with anthropometric measures obtained at delivery and at 2 months postpartum. We believe this project is significant because it deals with the prevention of excessive gestational weight gain and its associated adverse maternal and offspring health consequences. The study is also innovative; there have been no randomized controlled trials evaluating the effects of a behavioral lifestyle intervention with partial meal replacement program to promote healthy weight gain in multiethnic obese women. PUBLIC HEALTH RELEVANCE: This research project will help identify an effective program to help obese women gain a healthy amount of weight (and not too much) during pregnancy. If effective, this lifestyle program has the potential to prevent health problems in obese women and their offspring.