Clinical trial NCT03239054: Prescribing Exercise as Medicine in Pregnancy
Official title: Prescribing Exercise as Medicine in Pregnancy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnancy
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants will be randomized in a 1:1 fashion into the study group or the control group.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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".

Exclusion Criteria:

* 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

Primary outcomes:
measure: PARmed-X: Change in number of steps (physical activity level)
timeFrame: 1 year
Secondary outcomes:
measure: PARMed-X: Gestational Weight Gain
timeFrame: 1 year
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Shilpa Babbar, MD
role: PRINCIPAL_INVESTIGATOR
References: