Prescribing Exercise as Medicine in Pregnancy

Not Applicable

Withdrawn

• Conditions: Pregnancy
• Interventions: Behavioral: Physical activity; Behavioral: Control group

• Registration Number: NCT03239054
• Lead Sponsor: St. Louis University

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).

Study Timeline

• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-03
• Status Verified: 2018-07
• Study Start: 2018-07-01
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02
• Primary Completion: 2020-08-31
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Physical activity	Participants in the study group will complete the Parmed-X Pregnancy form and be provided with a prescription for exercise.
Control Group	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.

Primary Outcome Measures

Name	Time	Method
PARmed-X: Change in number of steps (physical activity level)	1 year	change in number of steps (physical activity level)

Secondary Outcome Measures

Name	Time	Method
PARMed-X: Gestational Weight Gain	1 year	Gestational Weight Gain

Trial Locations

Locations (1)

St. Mary's Health Center; 🇺🇸 Saint Louis, Missouri, United States