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临床试验/NCT02932202
NCT02932202
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Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy (WEIGHT) Trial

Loyola University0 个研究点2016年7月8日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Obesity
发起方
Loyola University
主要终点
Incidence of excessive weight gain
状态
撤回
最后更新
8年前

概览

简要总结

Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. The standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counseling. The objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.

详细描述

Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. The rates of obesity in American adults is 34.9% and the rates of excessive weight gain in pregnancy for all women range from 20-40% with even higher rates seen in the obese. Such high rates are putting mothers and infants at significant risk.· In 2009, the Institute of Medicine outlined clear guidelines for suggested weight gain goals based on pre-pregnancy BMI. Currently only 30-40% of pregnant women are meeting the suggested weight gain goals and the great majority not meeting the goals are gaining excessive weight. However, despite the high prevalence of excessive weight gain, there is little access to insurance covered nutrition counselling. The standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counselling. This can be challenging due to limited time and resources. However, there is good evidence that diet intervention reduces the risk of excessive weight gain by up to 20%. If appropriate nutritional counselling were available to all patients, the rates of excessive weight gain could be significantly impacted and have widespread improvement in pregnancy outcomes. The CDC has made important progress in providing free nutrition resources online to all patients. This study aims to incorporate this free resource with a sustainable ongoing nutrition counselling to impact the rates of excessive weight gain in pregnancy. The objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.

注册库
clinicaltrials.gov
开始日期
2016年7月8日
结束日期
2017年5月17日
最后更新
8年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

发起方
Loyola University
责任方
Principal Investigator
主要研究者

Scott Graziano

Associate Professor

Loyola University

入排标准

入选标准

  • Pregnancy identified less than 15 week 0 days gestational age
  • Body mass index greater then or equal to 18

排除标准

  • Multiple gestation
  • Pre-pregnancy diabetes mellitus

结局指标

主要结局

Incidence of excessive weight gain

时间窗: At time of delivery

To compare the effect of a medical student assisted program of nutritional counseling and web based nutrition tracking to standard of care on the incidence of excessive weight gain in pregnancy based on the Institute of Medicine's guidelines.

次要结局

  • Healthy Eating Habits(At time of delivery)
  • Pregnancy Comorbidity(At time of delivery)

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