Prescribing Exercise as Medicine in Pregnancy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- PARmed-X: Change in number of steps (physical activity level)
研究概览
简要总结
This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.
详细描述
This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise. Once screened and consented, participants will be randomized to either the intervention or control group in a 1:1 fashion. The intervention group will receive the PARMED-X prescription and the control group will receive routine care as usual. Physical activity will be monitored with a Polar fitness tracking device.
Maternal and neonatal outcomes will be collected from the electronic medical record. Maternal outcomes include demographics, total gestational weight gain, pre-pregnancy body mass index (BMI), BMI at the time of delivery, mode of delivery, glucose screen value, presence or absence of gestational diabetes and presence or absence of hypertensive disorders of pregnancy. Neonatal outcomes include gestational age at delivery, birth weight, Apgar scores, arterial cord blood gases.
Psychological outcomes will also be assessed using several validated scales in pregnancy including The Edinburgh Postnatal Depression Scale (EPDS) and The State Trait Anxiety Inventory (STAI).
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 45 years of age
- •Singleton pregnancy
- •Gestational age at or less than 20 0/7 weeks at the time of enrollment
- •Low risk pregnancy
- •Willing and able to participate in a more active lifestyle/exercise program
- •Smart phone able to add the "Flow mobile app".
排除标准
- •Twins or higher order multiple gestations
- •Known congenital anomaly
- •Underweight BMI ( BMI less than 18.50)
- •High risk pregnancy - ie. hypertension, pre-existing diabetes
- •Women with a known contraindication to exercise
- •Persistent 2nd or 3rd trimester vaginal bleeding
- •Hemodynamically significant heart disease
- •Restrictive lung disease
- •Incompetent cervix or cerclage
- •Placenta previa
- •Premature labor or rupture of membranes
- •Preeclampsia
- •Severe anemia
- •Poorly controlled hypertension, seizure disorder, or hyperthyroidism
- •Known intrauterine growth restriction
- •Not cleared for exercise by the "Contraindications to Exercise from PARMED-X" form
- •PAVS score greater than or equal to 150 minutes/week
研究组 & 干预措施
Study Group
Participants in the study group will complete the Parmed-X Pregnancy form and be provided with a prescription for exercise.
干预措施: Physical activity (Behavioral)
Control Group
The control group will be provided with the ACOG Pamphlet entitled "Exercise during pregnancy" and will be encouraged to become physically active during their pregnancy. They will receive routine care as scheduled.
干预措施: Control group (Behavioral)
结局指标
主要结局
PARmed-X: Change in number of steps (physical activity level)
时间窗: 1 year
change in number of steps (physical activity level)
次要结局
- PARMed-X: Gestational Weight Gain(1 year)
研究者
Shilpa Babbar, MD
Principal Investigator
St. Louis University