Pregnancy
Conditions
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).
Interventions
BEHAVIORALControl group
Information will be given as part of standard care
BEHAVIORALPhysical activity
pregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy
Sponsors
St. Louis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
participants will be randomized in a 1:1 fashion into the study group or the control group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PARmed-X: Change in number of steps (physical activity level) | 1 year | change in number of steps (physical activity level) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PARMed-X: Gestational Weight Gain | 1 year | Gestational Weight Gain |
Countries
United States
Outcome results
None listed