Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn
2018年5月6日 更新者：Ana Isabel Teixeira Jesus Silva、University of Minho
Sporty Bellies - Intervention Program During Pregnancy on Women and Newborn
"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.
研究概览
研究类型
介入性
注册 (实际的)
410
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Braga、葡萄牙
- Universidade Do Minho
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Do not have any medical or obstetric contraindication for physical exercise
Exclusion Criteria:
- 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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention Group
The program consists in 3 physical exercise classes, one of them in the pool.
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3 physical exercises classes, one of them in the pool.
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无干预：Control Group
The control group has the basic information through health professionals.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire"
大体时间：Baseline and 1 month after delivery
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Evaluation through "Pregnancy Physical Activity Questionnaire"
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Baseline and 1 month after delivery
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Change in Dietary intake assessed with the "Food frequency questionnaire"
大体时间：Baseline and 1 month after delivery
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Evaluation through "Food frequency questionnaire"
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Baseline and 1 month after delivery
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Gestational Weight gain
大体时间：1 day after delivery
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Values are self-reported by pregnant women
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1 day after delivery
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Change in Depressive Symptoms assessed with the "Edinburgh Postnatal Depression Scale"
大体时间：Baseline, 1 day after delivery and 1 month after delivery
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Evaluation through "Edinburgh Postnatal Depression Scale"
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Baseline, 1 day after delivery and 1 month after delivery
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Weight of the baby
大体时间：1 day after delivery
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Self-reported by participants
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1 day after delivery
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Length of the baby
大体时间：1 day after delivery
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Self-reported by participants
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1 day after delivery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 研究主任：Maria B Pereira、University of Minho
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年11月1日
初级完成 (实际的)
2017年12月31日
研究完成 (预期的)
2018年8月31日
研究注册日期
首次提交
2017年1月28日
首先提交符合 QC 标准的
2017年2月6日
首次发布 (估计)
2017年2月7日
研究记录更新
最后更新发布 (实际的)
2018年5月8日
上次提交的符合 QC 标准的更新
2018年5月6日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.