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临床试验/NCT04132310
NCT04132310
Enrolling By Invitation
不适用

Pregnancy Weight Trajectories and Offspring Adiposity

University of Texas at Austin4 个研究点 分布在 1 个国家目标入组 180 人2019年8月21日

概览

阶段
不适用
干预措施
N/A This is an observational study.
疾病 / 适应症
Pregnancy Related
发起方
University of Texas at Austin
入组人数
180
试验地点
4
主要终点
Infant percent fat at birth
状态
Enrolling By Invitation
最后更新
昨天

概览

简要总结

Early life influences (including the intrauterine environment, birth weight, and early postnatal growth) shape subsequent weight trajectories and future chronic disease risk. The MINT study will evaluate whether maternal fat mass changes are associated with specific maternal weight trajectories during pregnancy, and with neonatal adiposity at birth. The study is a prospective observational cohort currently enrolling women in early pregnancy,and following mothers and infants after birth.

详细描述

The Institute of Medicine (IOM) recommendations were established with limited evidence showing how the pattern of weight gain is associated with short-and long-term health of mothers and their children. Previous studies evaluated the impact of overall gestational weight gain pattern across gestation using latent class analysis and others have evaluated maternal weight change pattern-by trimester or early/late pregnancy-on offspring size and adiposity. However, it remains unclear if there are weight gain trajectories or specific periods of weight gain that are associated with greater adiposity in offspring, and whether effects persist across the life course. The MINT study will expand our understanding of determinants that are influencing maternal weight trajectories, including race/ethnicity, prepregnancy BMI and parity. Although many factors are well-established determinants of pregnancy weight gain, such as prepregnancy BMI and parity, there is limited understanding of whether these factors and others, such as maternal diet, race, psychosocial health or socio-economic status, influence the overall pattern of pregnancy weight gain and the IOM has called for research in this area. This knowledge is essential for providing personalized clinical recommendations for weight gain monitoring and to develop interventions to support healthy weight gain that optimizes health outcomes for mother and child. This study is an observational, prospective cohort design, and will recruit up to 60 volunteers with singleton gestations of BMI 18.5-35. The mothers' will be assessed at 14-15, 24-25, and 35 weeks of pregnancy, and at 6 weeks post-delivery. Additional measurements may also be collected at 6-, 12-, and 24-months postpartum. The measurements will include anthropometry (weight, height, circumferences, and skin fold thicknesses), and whole body magnetic resonance imaging (MRI) and/or dual-energy X-ray absorptiometry (DXA). The infants' measurements will be anthropometry at birth (2-3 days), and approximately 1 and 6 weeks. Additional measurements may also be collected at 6-, 12-, and 24-months. Infants will also undergo air displacement plethysmography (PeaPod) at approximately 1 week and 6 weeks, and potentially DXA at 12- and 24-months. Biospecimen samples will be collected, including: maternal serum, plasma, urine, microbiome, breastmilk, placenta, umbilical cord and cord blood, infant meconium and stool, and infant saliva. Data will be collected regarding mothers' dietary intake and physical activity (questionnaires and accelerometry). Other data to be collected include questionnaires on quality of life, socio-economic status, health behaviors and intentions. If the woman identifies a partner, the partner will be invited to complete questionnaires on health, health behaviors and anthropometry measures.

注册库
clinicaltrials.gov
开始日期
2019年8月21日
结束日期
2026年12月31日
最后更新
昨天
研究类型
Observational
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Elizabeth Widen

Assistant Professor

University of Texas at Austin

入排标准

入选标准

  • \<16 weeks gestation
  • Age \>18 years old
  • BMI \<35 kg/m2
  • Width \<48 cm

排除标准

  • Claustrophobia
  • Recent weight loss of \>5% of body weight before pregnancy
  • Weight-loss related surgery
  • Currently breastfeeding
  • Presence of any mechanically or magnetically activated implants, or any other contraindication for MRI

研究组 & 干预措施

MINT Participants

Up to 60 MINT maternal participant are linked with 60 infant participants, and 60 partner participants.

干预措施: N/A This is an observational study.

结局指标

主要结局

Infant percent fat at birth

时间窗: 24-72 hours after birth

Infant percent fat at birth as a continuous variable. This will be ascertained through neonatal skinfolds and anthropometry.

Maternal fat mass changes during pregnancy and postpartum

时间窗: 14, 24, 35 weeks gestation, and up to 24-months postpartum

Mother's fat mass at 14 weeks, 24 weeks, and 35 weeks gestation, and up to 24-months postpartum as a continuous variable. This will be ascertained through MRI and DXA.

次要结局

  • Maternal weight trajectories during pregnancy and postpartum(Weekly after enrollment (up to 6 weeks postpartum), biweekly 2 to 24 months postpartum)
  • Infant percent fat after birth(1-week to 24-months)
  • Maternal regional adipose tissue during pregnancy and postpartum(14, 24,35 weeks gestation, and up to 24-months postpartum)

研究点 (4)

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