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临床试验/NCT02750774
NCT02750774Unknown不适用

A Customized Low Glycaemic-index (GI) Diet, Introduced at First Trimester of Pregnancy by Both Gynecologist and Dietitian, Prevents Large for Gestational Age (LGA) Newborns in Overweight/Obese Pregnant Women

University of Modena and Reggio Emilia2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Large-for-gestational-age (LGA) occurrence

研究概览

简要总结

High pre-pregnancy body mass index (BMI) and excessive gestational weight gain (GWG) are associated with many unfavourable maternal and neonatal outcomes.

Adherence to lifestyle recommendations could be a major determinant of the efficacy on preventing unfavorable outcomes, namely among overweight/obese women. Previous studies investigated adherence to specific dietary patterns and their effect on pregnancy outcomes; however, no study has investigated adherence among overweight/obese pregnant women and its effect on the onset of several maternal-neonatal outcomes.

This study aimed to determine whether the prescription of a lifestyle program, consisting of a customized low-glycemic index (GI) diet and a physical activity program, in overweight and obese women could affect the occurrence LGA babies. It also aimed to determine whether this kind of prescription influences the adherence to healthier eating habits, and how this, in turn, can influence the occurrence LGA.

详细描述

High pre-pregnancy BMI and excessive GWG are associated with many unfavourable maternal and neonatal outcomes and are independent risk factors for gestational diabetes mellitus (GDM) and large for gestatiola age (LGA) babies. Overweight/obese women should be counselled regarding their body weight before conception; however, most women have access to obstetricians only when they are pregnant. The Institute of Medicine (IOM) revised the guidelines of recommended GWG according to the BMI; however, only a minority of women succeed in reaching the recommended GWG. Among the interventions aimed at preventing excessive GWG, few have demonstrated efficacy in high-risk populations; the principal issues are population heterogeneity, the interventional methods, and the timing of the interventional programs. Additionally, lifestyle interventions did not have a substantial effect on other clinical outcomes. Dietary advice to prevent gestational diabetes mellitus (GDM) appears to be beneficial in general, although the results are overly heterogeneous. A systematic review concerning exercise alone demonstrated no effect on preventing GDM, whereas another study showed only a slight protective effect. The reports evaluating the efficacy of diverse approaches (exercise, diet, lifestyle interventions, dietary supplements) to prevent GDM are of poor quality. Adherence to lifestyle recommendations could be a major determinant of their efficacy, specifically among overweight/obese women. Previous studies investigated adherence to specific dietary patterns and their effect on pregnancy outcomes; however, no study has investigated adherence among overweight/obese pregnant women and its effect on the onset of GDM. Nowadays, there are insufficient evidences for recommend a specific diet in preventing LGA babies.

This study aimed to determine whether the prescription of an early lifestyle program, consisting of a low-glycemic index (GI) caloric restriction and physical activity (PA), in overweight and obese women could affect the occurrence of LGA newborns. It also aimed to determine whether this kind of prescription influences the adherence to healthier eating habits, and how this, in turn, can influence the occurrence of LGA babies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age >18 years
  • singleton pregnancy
  • BMI >= 25 kg/m2

排除标准

  • Chronic diseases including diabetes mellitus (first trimester glycosuria> 100 mg/dl or fasting plasma glucose ≥126 mg/dL or random glycemia ≥ 200 mg/dL) and hypertension
  • Previous GDM
  • Medical conditions or dietary supplements that might affect the body weight (i.e., thyroid diseases)
  • Previous bariatric surgery
  • Smoking habits
  • Contraindications to exercise
  • Intent to deliver outside our hospital

结局指标

主要结局

Large-for-gestational-age (LGA) occurrence

时间窗: At delivery

LGA babies were defined if birthweight centile was ≥ 90°, and it was measured at delivery

Gestational Diabetes Mellitus (GDM) occurrence

时间窗: At 24-26 weeks

The diagnosis of GDM was made for any glucose value exceeding the normal cut-off, according to the Guidelines

次要结局

  • Gestational Weight Gain (GWG)(At baseline, at 16, 20, 28 and 36 weeks, at delivery and 3 months after delivery)
  • Pre-term Birth (PTB)(At delivery)
  • Neonatal hypoglycemia(Within 24 hours after delivery)
  • Neonatal Intensive Care Unit (NICU) admission(Within 24 hours after delivery)

研究者

发起方
University of Modena and Reggio Emilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Facchinetti Fabio

Professor Fabio Facchinetti

University of Modena and Reggio Emilia

研究点 (2)

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