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一项非限制序贯多项分配随机试验的设计和方法,旨在评估围产期干预措施的组合,以优化妇女健康。

Trial design and methodology for a non-restricted sequential multiple assignment randomized trial to evaluate combinations of perinatal interventions to optimize women's health.

机构信息

Department of Psychiatry, University of Pittsburgh, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.

Department of Statistics, University of Pittsburgh, 1800 Wesley W. Posvar Hall, 230 South Bouquet Street, Pittsburgh, PA 15260, USA.

出版信息

Contemp Clin Trials. 2019 Apr;79:111-121. doi: 10.1016/j.cct.2019.03.002. Epub 2019 Mar 6.

Abstract

Pre-pregnancy overweight/obesity and excessive gestational weight gain (GWG) independently predict negative maternal and child health outcomes. To date, however, interventions that target GWG have not produced lasting improvements in maternal weight or health at 12-months postpartum. Given that interventions solely aimed at addressing GWG may not equip women with the skills needed for postpartum weight management, interventions that address health behaviors over the perinatal period might maximize maternal health in the first postpartum year. Thus, the current study leveraged a sequential multiple assignment randomized trial (SMART) design to evaluate sequences of prenatal (i.e., during pregnancy) and postpartum lifestyle interventions that optimize maternal weight, cardiometabolic health, and psychosocial outcomes at 12-months postpartum. Pregnant women (N = 300; ≤16 weeks pregnant) with overweight/obesity (BMI ≥ 25 kg/m) are being recruited. Women are randomized to intervention or treatment as usual on two occasions: (1) early in pregnancy, and (2) prior to delivery, resulting in four intervention sequences. Intervention during pregnancy is designed to moderate GWG and introduce skills for management of weight as a chronic condition, while intervention in the postpartum period addresses weight loss. The primary outcome is weight at 12-months postpartum and secondary outcomes include variables of cardiometabolic health and psychosocial well-being. Analyses will evaluate the combination of prenatal and postpartum lifestyle interventions that optimizes maternal weight and secondary outcomes at 12-months postpartum. Optimizing the sequence of behavioral interventions to address specific needs during pregnancy and the first postpartum year can maximize intervention potency and mitigate longer-term cardiometabolic health risks for women.

摘要

孕前超重/肥胖和孕期体重过度增加(GWG)都会对母婴健康产生负面影响。然而,迄今为止,针对 GWG 的干预措施并未在产后 12 个月时改善女性的体重或健康状况。鉴于仅针对 GWG 的干预措施可能无法使女性具备产后体重管理所需的技能,因此,针对围产期健康行为的干预措施可能会最大限度地提高女性在产后第一年的健康水平。因此,本研究利用序贯多重分配随机试验(SMART)设计来评估优化产后生活方式干预的顺序,以在产后 12 个月时优化产妇的体重、心血管代谢健康和心理社会结局。研究正在招募超重/肥胖(BMI≥25kg/m)的孕妇(N=300;怀孕≤16 周)。女性在两次机会被随机分配到干预组或常规治疗组:(1)在怀孕早期,(2)在分娩前,从而产生了四种干预顺序。孕期干预旨在适度控制 GWG 并引入管理体重作为慢性病的技能,而产后干预则解决体重减轻问题。主要结局是产后 12 个月时的体重,次要结局包括心血管代谢健康和心理社会幸福感的变量。分析将评估优化产前和产后生活方式干预的组合,以在产后 12 个月时优化产妇体重和次要结局。优化针对怀孕和产后第一年特定需求的行为干预措施的顺序,可以最大限度地提高干预的效力,并减轻女性长期心血管代谢健康风险。

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