Optimizing health from pregnancy through one year postpartum: A sequential multiple assignment randomized trial (SMART) of perinatal lifestyle intervention

项目摘要 围产期，从怀孕到产后第一年， 妇女的健康。过度妊娠体重增加（GWG）与有害的健康结果有关;然而，大多数 妇女超过了GWG制定的指南，特别是开始怀孕超重或 肥胖这些妇女很可能在产后一年仍然超重或肥胖，即使GWG在 指南和妊娠相关的体重增加是失去产后。努力减轻与下列方面有关的健康风险： 围产期超重对妇女长期肥胖和心脏代谢有很大的好处。 健康到目前为止，干预措施，以尽量减少过多的GWG单独的影响有限。一些女性可能 需要在产后期间持续干预，以实现最佳体重管理。可选择地， 仅在产后进行干预可能足以在产后一年达到更健康的体重。 由于妇女在怀孕期间和产后的需要各不相同，因此调整干预措施也很重要。 因此，本申请提出了序贯多分配随机试验（SMART）， 确定在怀孕期间、产后或两者的不同干预序列的功效。这个非- 限制SMART也将使我们能够调查不同干预组合的影响， GWG的功能。拟议的SMART是创新的，作为第一次努力，以评估不同的序列， 在整个围产期采取干预措施，以减少产后一年的孕产妇健康风险。 按产前体重状态（BMI=25-29.9 vs. ≥30）分层的妊娠女性（N=300）将在 进入产前护理，最初随机接受干预，以解决体重和 怀孕期间的自我调节（健康和过渡行为[HABITpreg]）或教育- 常规强化治疗（TAUpreg）。分娩时，妇女将被重新随机分配到产后自我- 监管干预HABITpost或TAUpost。妇女将在产前基线完成评估， 怀孕结束，产后6个月和12个月。具体目标是确定：（1）组合 产前和产后生活方式干预，改善产妇体重，心脏代谢健康， 产后12个月时的抑郁症状和压力，以及（2）评估以下组合的影响： GWG对产妇体重和健康结果的干预措施。我们还将（3）研究预- 妊娠期体重状况对最佳干预顺序的影响。例如，分配给HABITpre 其次是HABITpost可以改善肥胖妇女的结果，无论GWG如何，而分配到 只有当GWG过量时，超重妇女才需要TAU，然后是HABITpost。的 拟议的研究是我们调查小组以前进行的围产期健康研究的延伸， 并将提供关于围产期行为干预的选择和时机的数据，以减轻 对女性的长期心脏代谢健康风险。

Project Summary The perinatal period, from pregnancy through the first postpartum year, has important implications for women's health. Excessive gestational weight gain (GWG) is linked to deleterious health outcomes; yet most women exceed guidelines established for GWG, particularly women who begin pregnancy overweight or obese. These women are likely to remain overweight or obese at one year postpartum even if GWG is within guidelines and pregnancy-related weight gain is lost postpartum. Efforts to mitigate the health risks related to perinatal overweight can have substantial benefits for women's longer-term obesity and cardiometabolic health. To date, interventions to minimize excessive GWG alone have had limited impact. Some women may require continued intervention in the postpartum period to achieve optimal weight management. Alternatively, intervention delivered only postpartum may be sufficient to achieve a healthier weight at one year postpartum. It also is important to adapt intervention as women's needs vary over the course of pregnancy and postpartum. Accordingly, this application proposes a sequential multiple assignment randomized trial (SMART) to determine the efficacy of different intervention sequences during pregnancy, postpartum, or both. This non- restricted SMART also will allow us to investigate the impact of different combinations of intervention as a function of GWG. The proposed SMART is innovative as the first effort to evaluate different sequences of intervention across the perinatal period to mitigate maternal health risk by one year postpartum. Pregnant women (N=300), stratified by prenatal weight status (BMI=25-29.9 vs. ≥30) will be enrolled at entry into prenatal care and randomized initially to intervention that addresses the challenges of weight and self-regulation during pregnancy (Health and Behaviors in Transition [HABITpreg]) or an educationally- enhanced treatment as usual (TAUpreg). At delivery, women will be re-randomized to a postpartum self- regulation intervention HABITpost or TAUpost. Women will complete assessments at a prenatal baseline, the end of pregnancy, and 6- and 12-months postpartum. The specific aims are to determine: (1) the combination of prenatal and postpartum lifestyle interventions that improves maternal weight, cardiometabolic health, depressive symptoms and stress at 12-months postpartum, and (2) evaluate the impact of combinations of interventions by GWG on maternal weight and health outcomes. We also will (3) examine the impact of pre- pregnancy weight status on the optimal sequence of interventions. For example, assignment to HABITpre followed by HABITpost may improve outcomes for obese women, regardless of GWG, whereas assignment to TAU followed by HABITpost may be needed for overweight women only when GWG is excessive. The proposed research is an extension of previous perinatal health research conducted by our investigative team, and will provide data on the selection and timing of behavioral interventions in the perinatal period to mitigate longer-term cardiometabolic health risks for women.