Prescribing Exercise as Medicine in Pregnancy

Prescribing Exercise as Medicine in Pregnancy: A Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: Physical activity; Behavioral: Control group

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • St. Mary's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study Group; Participants in the study group will complete the Parmed-X Pregnancy form and be provided with a prescription for exercise.	Behavioral: Physical activity; pregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy
OTHER: 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.	Behavioral: Control group; Information will be given as part of standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PARmed-X: Change in number of steps (physical activity level)	change in number of steps (physical activity level)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PARMed-X: Gestational Weight Gain	Gestational Weight Gain	1 year

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Shilpa Babbar, MD, St. Louis University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): August 31, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (ACTUAL): August 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 28028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No