Fit For Delivery: A Study of the Effect of Exercise Intervention and Nutritional Counselling on Pregnancy Outcome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 606
- 试验地点
- 1
- 主要终点
- Weight of the newborn
研究概览
简要总结
"Fit for Delivery" is a randomized, controlled study to examine the effects of an intervention during pregnancy which consists of exercise groups and nutritional counselling. The investigators will assess the outcomes of gestational weight gain, postpartum weight retention, large newborns, glucose regulation, and the incidence of complications of pregnancy and delivery such as gestational diabetes and Cesarean section.
详细描述
"Fit for Delivery" is a randomized, controlled study to examine the effects of an intervention during pregnancy which consists of exercise groups and nutritional counselling. The investigators intend to study 600 women who are expecting their first child, and include them in the study at the time of their first appointment at their local healthcare clinic, when they are between 12 and 20 weeks of pregnancy. All women who wish to participate will sign an informed consent.
Women who are randomly assigned to the intervention group will receive two telephone consultations with nutritional advice on healthy eating during pregnancy. They will also be counselled about appropriate weight gain during pregnancy given their pre-pregnancy body mass index. They will be assigned to an exercise group which will meet twice a week for a specially designed workout, and will be encouraged to exercise once or twice weekly on their own. Women in the intervention group will also have access to a password-protected internet site with information on healthy living during pregnancy, and be invited to 2 or 3 evening classes with nutritional information. Women who are randomly assigned to the control group will receive routine pregnancy care.
All women in the study will be studied using:
- questionaires
- two ultrasound examinations (at 30 and 36 weeks of pregnancy),
- blood tests, including a 2 hour glucose challenge test, and measurement of hormones which regulate blood glucose levels
- weighing of the participant, including use of a bioimpedance scale
- weighing and measuring of her newborn baby,
- blood tests from the umbilical cord, measuring hormones which regulate blood glucose levels
- review of hospital records regarding mode of delivery, delivery complications and possible neonatal admissions for the newborn child.
The investigators' hypothesis is that an intervention in the form of nutritional information and exercise groups will:
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
- Single (Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Expecting first child
- •Gestational weeks 12-20
- •Residence in one of the following towns: Kristiansand, Søgne, Sogndalen, Vennesla, Lillesand, Mandal
排除标准
- •Twin or other multiple pregnancy
- •Preexisting diabetes
- •Physical handicap which precludes participation in exercise groups
- •Ongoing drug addiction
- •Serious mental disorder
- •BMI at or below 19 before pregnancy
- •Inability to read/write Norwegian or English
研究组 & 干预措施
Nutritional counseling + exercise groups
Women in this arm will receive 2 telephone consultations on nutritional health during pregnancy, be invited to 2 evening meetings with nutritional topics and have access to a password protected internet site with topics related to nutrition and fitness in pregnancy. They will also be enrolled in an exercise group which will meet twice weekly, and be encouraged to exercise on their own 1-2 times each week.
干预措施: Nutritional counseling + exercise groups (Behavioral)
control
Women in this arm of the study will receive routine pregnancy care.
结局指标
主要结局
Weight of the newborn
时间窗: Measured at the time of delivery
weight in grams at delivery
Incidence of operative delivery, both cesarean section and operative vaginal delivery
时间窗: Assessed following delivery
number of participants delivered by operative vaginal or cesarean section
Maternal weight gain in pregnancy
时间窗: Measured at the time of delivery
weight gain in kg
Maternal fasting serum glucose level
时间窗: Measured at gestational week 30
serum glucose
Maternal body composition
时间窗: Measured at 36 weeks of gestation
Measured using bioimpedance scale
次要结局
- Measurement of serum levels of hormones which regulate serum glucose levels, in both the pregnant woman and her newborn baby.(Mother measured at gestational week 30, baby measured at delivery)
- Incidence of women with serum glucose levels >7.8 mmol/l after 2 hour glucose challenge test(Assessed at gestational week 30)
- Proportion of newborns with birth weight over the 90th percentile for gestational age(Assessed following delivery)
- Incidence of delivery complications(Assessed following delivery)
- Maternal weight retention(12 months after delivery)