Prescribing Exercise as Medicine in Pregnancy

NCT03239054 | Withdrawn

• 1 other identifier: 28028
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• PARmed-X: Change in number of steps (physical activity level)

  change in number of steps (physical activity level)

  1 year

Secondary Outcomes (1)

• PARMed-X: Gestational Weight Gain

  1 year

Study Arms (2)

Study Group

EXPERIMENTAL

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

Behavioral: Physical activity

Control Group

OTHER

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

Interventions

Physical activity BEHAVIORAL

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

Study Group

Control group BEHAVIORAL

Information will be given as part of standard care

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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".

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

MeSH Terms

Interventions

Exercise; Control Groups

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Shilpa Babbar, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: participants will be randomized in a 1:1 fashion into the study group or the control group.

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: August 3, 2017
• Study Start: July 1, 2018
• Primary Completion: August 31, 2020
• Study Completion: December 1, 2020
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)