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临床试验/NCT02703753
NCT02703753终止不适用

TOwards Prepared Mums (TOP-mums), for a Healthy Start: A Lifestyle Intervention to Reduce Overweight and Smoking in Women With a Pregnancy Wish to Prevent Perinatal Morbidity

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2016年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
76
试验地点
2
主要终点
Reduction in body weight

研究概览

简要总结

This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. Half of the patients will receive the lifestyle intervention while the other half will receive usual care. It is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.

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

  • Women with a pregnancy wish within 1 year;
  • Aged 18-40 years;
  • Overweight/obesity (BMI ≥ 25 kg/m2).

排除标准

  • Haemodynamically significant heart disease;
  • Restrictive lung disease;
  • Congenital metabolic disease;
  • Mentally retarded;
  • Bariatric surgery;
  • Diabetes type II, dependent on medicine.

结局指标

主要结局

Reduction in body weight

时间窗: From baseline to 6 weeks postpartum

次要结局

  • HDL cholesterol of the child(At birth and 12 months postpartum)
  • Respiratory rate of the child(Will be measured at 6 weeks and 12 months postpartum)
  • Miscarriage(During pregnancy: at 6, 12 and 20 weeks of gestational age.)
  • Gestational weight gain(6 weeks of gestational age to 36 weeks of gestational age)
  • Delivery complications(At birth)
  • Gamma-GT(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • ALAT(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • LDL cholesterol of the child(At birth and 12 months postpartum)
  • Respiratory system resistance of the child(Will be measured at 6 weeks and 12 months postpartum)
  • Fasting insulin level(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • Postpartum weight retention(6 weeks of gestational age to 6 months postpartum)
  • Biochemical verification of tobacco use(Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.)
  • Dietary habits(Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.)
  • Physical activity habits(Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.)
  • Vitamin D status(Will be measured at baseline and at 32 weeks of gestational age.)
  • Dysmaturity and macrosomia(At birth)
  • Smoking cessation(Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.)
  • Insuline resistance (HOMA-IR)(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • Total cholesterol(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • Blood pressure(Will be measured at baseline; Prepregnancy: after 1, 2, 3, 6, 9 and 12 months; During pregnancy: at 6, 12, 20, 32, 36 and 40 weeks of gestational age; Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.)
  • Pulse wave velocity(Will be measured at baseline; Prepregnancy: after 3, 6 and 12 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: at 6 and 12 months.)
  • Time to pregnancy(From pregnancy wish to first day of last menstruation)
  • Fasting glucose level(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • LDL cholesterol(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • HDL cholesterol(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • Free fatty acids(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • ASAT(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • Fat mass and fatt free mass(Will be measured at baseline, at 32 weeks of gestational age during pregnancy and 6 months postpartum)
  • Fasting glucose level of the child(At birth and 12 months postpartum)
  • Fasting insulin level of the child(At birth and 12 months postpartum)
  • Pregnancy complications(At birth)
  • Prematurity(At birth)
  • Insulin resistance (HOMA-IR) of the child(At birth and 12 months postpartum)
  • Total cholesterol of the child(At birth and 12 months postpartum)
  • Triglycerides(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • Alkaline phosphatase(Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.)
  • Tidal volume of the child(Will be measured at 6 weeks and 12 months postpartum)
  • Respiratory system reactance of the child(Will be measured at 6 weeks and 12 months postpartum)
  • Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion nitroprusside(Will be measured at 6 weeks and 3 and 12 months postpartum)
  • Triglycerides of the child(At birth and 12 months postpartum)
  • Free fatty acids of the child(At birth and 12 months postpartum)
  • Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion acetylcholine(Will be measured at 6 weeks and 3 and 12 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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