Perreault Maude, Atkinson Stephanie A, Mottola Michelle F, Phillips Stuart M, Bracken Keyna, Hutton Eileen K, Xie Feng, Meyre David, Morassut Rita E, Prapavessis Harry, Thabane Lehana
Department Pediatrics, HSC 3A44, McMaster University, 1280 Main St W, Hamilton, ON, L8S 4K1, Canada.
School of Kinesiology, Western University, London, ON, Canada.
Trials. 2018 Dec 19;19(1):691. doi: 10.1186/s13063-018-3065-x.
Evidence from epidemiological and animal studies support the concept of programming fetal, neonatal, and adult health in response to in utero exposures such as maternal obesity and lifestyle variables. Excess gestational weight gain (GWG), maternal physical activity, and sub-optimal and excess nutrition during pregnancy may program the offspring's risk of obesity. Maternal intake of dairy foods rich in high-quality proteins, calcium, and vitamin D may influence later bone health status. Current clinical practice guidelines for managing GWG are not founded on randomized trials and lack specific "active intervention ingredients." The Be Healthy in Pregnancy (BHIP) study is a randomized controlled trial (RCT) designed to test the effectiveness of a novel structured and monitored Nutrition + Exercise intervention in pregnant women of all pre-pregnancy weight categories (except extreme obesity), delivered through prenatal care in community settings (rather than in hospital settings), on the likelihood of women achieving recommended GWG and a benefit to bone status of offspring and mother at birth and six months postpartum.
The BHIP study is a two-site RCT that will recruit up to 242 participants aged > 18 years at 12-17 weeks of gestation. After baseline measures, participants are randomized to either a structured and monitored Nutrition + Exercise (intervention) or usual care (control) program for the duration of their pregnancy. The primary outcome of the study is the percent of women who achieve GWG within the Institute of Medicine (IOM) guidelines. The secondary outcomes include: (1) maternal bone status via blood bone biomarkers during pregnancy; (2) infant bone status in cord blood; (3) mother and infant bone status measured by dual-energy absorptiometry scanning (DXA scan) at six months postpartum; (4) other measures including maternal blood pressure, blood glucose and lipid profiles, % body fat, and postpartum weight retention; and (5) infant weight z-scores and fat mass at six months of age.
If effective, this RCT will generate high-quality evidence to refine the nutrition guidelines during pregnancy to improve the likelihood of women achieving recommended GWG. It will also demonstrate the importance of early nutrition on bone health in the offspring.
ClinicalTrials.gov, NCT01689961 Registered on 21 September 2012.
流行病学和动物研究的证据支持了这样一种概念，即胎儿、新生儿和成人的健康可因子宫内暴露（如母亲肥胖和生活方式变量）而受到影响。孕期体重过度增加（GWG）、母亲的身体活动以及孕期营养不足和过量都可能影响后代患肥胖症的风险。母亲摄入富含优质蛋白质、钙和维生素D的乳制品可能会影响后代日后的骨骼健康状况。目前关于管理GWG的临床实践指南并非基于随机试验，且缺乏具体的“积极干预要素”。孕期健康（BHIP）研究是一项随机对照试验（RCT），旨在测试一种新颖的结构化且受监测的营养+运动干预措施对所有孕前体重类别（极端肥胖除外）的孕妇的有效性，该干预通过社区环境（而非医院环境）的产前护理实施，以提高女性达到推荐GWG的可能性，并对后代及母亲在出生时和产后六个月的骨骼状况产生有益影响。
BHIP研究是一项双中心RCT，将招募多达242名妊娠12 - 17周、年龄大于18岁的参与者。在进行基线测量后，参与者在整个孕期被随机分配到结构化且受监测的营养+运动（干预）或常规护理（对照）方案。该研究的主要结局是在医学研究所（IOM）指南范围内实现GWG的女性百分比。次要结局包括：（1）孕期通过血液骨生物标志物评估的母亲骨骼状况；（2）脐带血中的婴儿骨骼状况；（3）产后六个月通过双能吸收测定扫描（DXA扫描）测量的母亲和婴儿骨骼状况；（4）其他测量指标，包括母亲的血压、血糖和血脂谱、体脂百分比以及产后体重保留情况；（5）婴儿在六个月大时的体重z评分和脂肪量。
如果该RCT有效，将产生高质量证据以完善孕期营养指南，提高女性达到推荐GWG的可能性。它还将证明早期营养对后代骨骼健康的重要性。
ClinicalTrials.gov，NCT01689961，于2012年9月21日注册。
