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.

项目概要 围产期，从怀孕到产后第一年，对 妊娠体重过度增加（GWG）与有害的健康结果有关； 女性指南超出了 GWG 的规定，特别是怀孕时体重超标或 即使 GWG 在产后一年内，这些女性也可能保持超重或肥胖。 指导方针和与怀孕相关的体重增加在产后失去了减轻相关健康风险的努力。 围产期超重对女性长期肥胖和心脏代谢有显着益处 迄今为止，仅减少过量 GWG 的干预措施对一些妇女的影响可能有限。 需要在产后持续干预以实现最佳体重管理。 仅在产后进行干预可能足以在产后一年内达到更健康的体重。 适应性干预也很重要，因为女性的需求在怀孕和产后过程中会有所不同。 因此，本申请提出了序贯多重分配随机试验（SMART） 确定怀孕期间、产后或两者期间不同干预顺序的效果。 有限的 SMART 还将使我们能够调查不同干预组合的影响 GWG 的功能是创新的，它是评估不同序列的第一个努力。 在整个围产期进行干预，以在产后一年内降低孕产妇健康风险。 按产前体重状况分层（BMI=25-29.9 vs. ≥30）的孕妇（N=300）将在 进入产前护理并最初随机接受针对体重和体重挑战的干预措施 怀孕期间的自我调节（过渡期的健康和行为 [HABITpreg]）或教育- 照常加强治疗 (TAUpreg) 分娩时，妇女将被重新随机分配到产后自我治疗组。 监管干预 HABITpost 或 TAUpost 女性将完成产前基线评估。 具体目标是确定： (1) 组合。 产前和产后生活方式干预可改善产妇体重、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 对孕产妇体重和健康结果的干预措施我们还将 (3) 检查预产期的影响。 妊娠体重状况对最佳干预顺序的影响 例如，HABITpre 的分配。 随后进行 HABITpost 可能会改善肥胖女性的结果，无论 GWG 是多少，而分配到 只有当 GWG 过多时，超重女性才可能需要 TAU，然后进行 HABITpost。 拟议的研究是我们的调查团队之前进行的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。