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临床试验/NCT03045237
NCT03045237Unknown不适用

Sporty Bellies - Intervention Program During Pregnancy on Women and Newborn

University of Minho1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
410
试验地点
1
主要终点
Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire"

研究概览

简要总结

"Healthy Bellies" is an intervention program with pregnant women, based on the promotion of healthy lifestyles. It aims to evaluate the impact of the program in the health of both pregnant and newborn. This trial is being conducted with pregnant women, divided into control and intervention group. Are performed 3 assessment periods: 1 - beginning of the program; 2 - postpartum; 3 - 1 month after delivery. The intervention group has a program of 3 weekly physical exercise classes and the control group has the basic information that is usually provided by health professionals. With this program, it is expected to contribute with evidence to the best practice in the field of interventions in pregnancy and improve health outcomes of both pregnant and newborn.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Do not have any medical or obstetric contraindication for physical exercise

排除标准

  • •Haemodynamically significant heart disease;
  • •restrictive lung disease;
  • •incompetent cervix/cerclage;
  • •multiple gestation at risk for premature labor;
  • •persistent second or third trimester bleeding;
  • •placenta praevia after 26 weeks gestation;
  • •premature labor during the current pregnancy;
  • •ruptured membranes;
  • •pregnancy induced hypertension;
  • •severe anaemia;
  • •unevaluated maternal cardiac arrhythmia;
  • •chronic bronchitis;
  • •poorly controlled type I diabetes;
  • •extreme morbid obesity;
  • •extreme underweight (body mass index <12);
  • •history of extremely sedentary lifestyle;
  • •intrauterine growth restriction in current pregnancy;
  • •poorly controlled hypertension/pre-eclampsia;
  • •orthopaedic limitations;
  • •poorly controlled seizure disorder;
  • •poorly controlled thyroid disease; heavy smoker).

研究组 & 干预措施

Intervention Group

Experimental

The program consists in 3 physical exercise classes, one of them in the pool.

干预措施: physical exercises classes (Other)

Control Group

No Intervention

The control group has the basic information through health professionals.

结局指标

主要结局

Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire"

时间窗: Baseline and 1 month after delivery

Evaluation through "Pregnancy Physical Activity Questionnaire"

Change in Dietary intake assessed with the "Food frequency questionnaire"

时间窗: Baseline and 1 month after delivery

Evaluation through "Food frequency questionnaire"

Gestational Weight gain

时间窗: 1 day after delivery

Values are self-reported by pregnant women

Change in Depressive Symptoms assessed with the "Edinburgh Postnatal Depression Scale"

时间窗: Baseline, 1 day after delivery and 1 month after delivery

Evaluation through "Edinburgh Postnatal Depression Scale"

Weight of the baby

时间窗: 1 day after delivery

Self-reported by participants

Length of the baby

时间窗: 1 day after delivery

Self-reported by participants

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Isabel Teixeira Jesus Silva

PhD Student

University of Minho

研究点 (1)

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