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: 10020430
• 负责人: MICHELE D LEVINE
• 金额: $ 69.66万
• 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 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10020430
• 关键词: Address; Behavior Therapy; Body Weight Changes; Data; Enrollment; Experimental Designs; First Pregnancy Trimester; 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; Sequential Multiple Assignment Randomized Trial; Smoking; Stress; Weight; Weight Gain; Weight maintenance regimen; Woman; Women' s Health; Work; base; cardiometabolic risk; cardiometabolism; depressive symptoms; design; gestational weight gain; healthy weight; improved; improved outcome; innovation; lifestyle intervention; maternal weight; perinatal health; perinatal intervention; perinatal period; postpartum weight; prenatal; prenatal intervention; prepregnancy; prepregnancy obesity; prevent; primary outcome; psychosocial; public health relevance; response; secondary outcome; skills; successful intervention; 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 从怀孕到产后第一年的围产期，对 妇女健康。过度的妊娠体重增加（GWG）与有害的健康结果有关；最多 妇女超出了为GWG制定的准则，尤其是开始怀孕超重或 肥胖。这些妇女在产后一年可能会超重或肥胖，即使GWG不在 指南和与妊娠有关的体重增加失去产后。减轻与健康风险有关的努力 围产期超重可以为妇女的长期肥胖和心脏代谢带来可观的好处 健康。迄今为止，仅仅使多余的GWG最小化的干预措施的影响有限。有些妇女可能会 需要在产后继续干预以实现最佳体重管理。或者， 仅提供产后的干预措施可能足以实现产后一年的更健康的体重。 适应干预措施也很重要，因为妇女的需求在怀孕和产后的过程中有所不同。 根据此申请提案，一个顺序多次分配随机试验（SMART） 确定怀孕，产后或两者兼而有之不同干预序列的效率。这个非 - 受限制的SMART还将使我们能够调查不同干预组合的影响 GWG的功能。拟议的智能是创新的，是评估不同序列的第一个努力 整个围产期的干预措施以减轻产后一年的生物健康风险。 孕妇（n = 300），通过产前体重状况分层（BMI = 25-29.9vs.≥30）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（过渡中的健康和行为[Habepreg]）或教育 像往常一样增强治疗（taupreg）。分娩时，妇女将被重新融合到产后自我 调节干预措施生个或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。具体目的是确定：（1）组合 产前和产后生活方式的干预措施，可改善母校体重，心脏代谢健康， 产后12个月的抑郁症状和压力，（2）评估组合的影响 GWG干预产妇体重和健康成果。我们还将（3）研究前的影响 怀孕体重状态在干预措施的最佳序列上。例如，分配给生p 其次是栖息地，无论GWG如何 只有在GWG过度时，可能需要超重的女性才需要tau。这 拟议的研究是我们调查团队进行的先前围产期健康研究的延伸 并将提供有关围产期行为干预措施的选择和时机的数据，以减轻 女性的长期心脏代谢健康风险。