Prescribing Exercise as Medicine in Pregnancy

NCT ID: NCT03239054

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-12-01

Brief Summary

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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

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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).

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

participants will be randomized in a 1:1 fashion into the study group or the control group.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study Group

Participants in the study group will complete the Parmed-X Pregnancy form and be provided with a prescription for exercise.

Group Type EXPERIMENTAL

Physical activity

Intervention Type BEHAVIORAL

pregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy

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.

Group Type OTHER

Control group

Intervention Type BEHAVIORAL

Information will be given as part of standard care

Interventions

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Physical activity

pregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy

Intervention Type BEHAVIORAL

Control group

Information will be given as part of standard care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Louis University

OTHER

Sponsor Role lead

Responsible Party

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Shilpa Babbar, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shilpa Babbar, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

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St. Mary's Health Center

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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28028

Identifier Type: -

Identifier Source: org_study_id

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