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

优化从怀孕到产后一年的健康：围产期生活方式干预的序贯多重分配随机试验 (SMART)

• 批准号: 9195238
• 负责人: MICHELE D LEVINE
• 金额: $ 74.37万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9195238
• 关键词: Address; Behavior Therapy; Body Weight Changes; Data; Enrollment; Experimental Designs; Goals; Guidelines; Health; Health Benefit; Health behavior; Informal Social Control; Intervention; Link; Maternal Health; Maternal and Child Health; Moods; Obesity; Outcome; Overweight; Perinatal; Postpartum Period; Pregnancy; Pregnant Women; Prenatal care; Public Health; Randomized; Research; Risk; Smoking; Stress; Time; Weight; Weight Gain; Weight maintenance regimen; Woman; Women' s Health; Work; base; cardiometabolic risk; depressive symptoms; design; gestational weight gain; healthy weight; improved; improved outcome; innovation; lifestyle intervention; meetings; perinatal health; perinatal intervention; prenatal; prenatal intervention; prevent; primary outcome; psychosocial; randomized trial; response; secondary outcome; skills; therapy design; treatment as usual

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.

项目摘要 围产期，从怀孕到产后第一年，对 妇女健康。妊娠期体重过度增加(GWG)与有害的健康后果有关；但大多数 妇女超过为GWG制定的指导方针，特别是开始怀孕、超重或 太胖了。即使GWG在产后一年内，这些女性仍有可能超重或肥胖。 指导方针和怀孕相关的体重增加是产后丢失的。努力减轻与以下方面有关的健康风险 围产期超重对女性长期肥胖和心脏代谢有很大好处 健康。到目前为止，仅靠干预措施尽量减少过多的全球工作组的影响有限。有些女性可能 需要在产后持续干预，以实现最佳的体重管理。或者， 仅在产后实施干预可能足以在产后一年实现更健康的体重。 同样重要的是采取适当的干预措施，因为妇女在怀孕期间和产后的需要各不相同。 因此，本申请提出了序贯多分配随机试验(SMART)以 确定孕期、产后或两者的不同干预顺序的效果。这个非- 受限的SMART还将允许我们调查不同干预组合的影响 GWG的功能。建议的SMART是创新的，作为评估不同序列的第一次努力 在整个围产期采取干预措施，在产后一年内降低产妇的健康风险。 孕妇(N=300)，按产前体重状况(BMI=25-29.9vs.≥30)分层，将在 进入产前护理，最初随机进行干预，以应对体重和 怀孕期间的自我调节(转变中的健康和行为[HABITpreg])或教育- 常规强化治疗(TAUpreg)。在分娩时，妇女将被重新随机分配到产后自我检查 监管干预HABITPOST或TAUPOST。妇女将在产前基线上完成评估， 妊娠结束，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，改善母亲体重，心脏代谢健康， 产后12个月的抑郁症状和压力，以及(2)评估联合应用 全球工作组对产妇体重和健康结果的干预。我们还将(3)研究预 孕期体重状况对最佳干预顺序的影响。例如，对HABITpre的赋值 无论GWG如何，紧随其后的HABITpost可能会改善肥胖女性的预后，而分配到 只有当GWG过多时，超重女性才需要Tau和HABITpost。这个 拟议的研究是我们调查团队之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，以缓解 对女性心脏代谢健康的长期风险。