Prenatal Education Video Study (PEVS)

December 18, 2013 updated by: Ann Kellams, MD, University of Virginia
A randomized, controlled trial will be conducted during which pregnant women will be randomized to receive the intervention - viewing a prenatal education video about how to breastfeed an infant - or the sham intervention - viewing a prenatal education video about maternal nutrition and physical activity during pregnancy. Participants will be interviewed via telephone at one, three, and six months post-partum to determine how they feed their infants at each of these time frames.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Research assistants will screen potential candidates at the University of Virginia Health System and Virginia Commonwealth University Primary Care Center and approach potential participants during a standard clinic visit. The charts of the day's patients will be screened prior to approaching women to invite them to enroll in the study.

Following administration of the enrollment questionnaire, the patient will be randomized to the intervention or sham intervention arm of the study. The research assistant will open the study packet with the corresponding study identification number containing the intervention assignment. The research assistant will then load the assigned video into the DVD player and ask the patient to view the video. The participants will be blinded to which video is the true intervention.

Following delivery, research assistants will abstract the medical records of the woman and infant. Data regarding complications for both the mother and baby will be recorded and the length of stay for mother and baby as well as information about the way in which the baby was fed during the hospital stay.

Participants will be administered a one-month follow-up questionnaire by telephone. Follow-up questionnaires will be administered by research staff that did not enroll the participant such that the research assistant administering the telephone questionnaire will be blinded to the patient's assigned intervention group. The three-month questionnaire will be administered by telephone in the same fashion as the one-month. The six-month questionnaire will be administered by telephone. This questionnaire will conclude the study. A current address will be obtained at this time, and a children's book will be mailed to the participant thanking her for completing the study. For subjects lost to follow-up, we will contact the baby's pediatrician to retrieve the information on the questionnaires.

Study Type

Interventional

Enrollment (Actual)

522

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Richmond, Virginia, United States, 23284
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Receiving prenatal care at the Primary Care Center, University Physicians for Women at Northridge, the University of Virginia Teen Health Center
  • WIC-eligible 185% Federal poverty Enrolled in Medicaid, TANF, food stamps
  • Pregnant, 24 - 41 weeks gestation
  • Singleton gestation
  • Access to a telephone
  • Plan to deliver at UVa
  • Primary language is English or Spanish

Exclusion Criteria:

  • Multiple gestation
  • Known contraindication to breastfeeding Illicit drug use HIV + Recipient of chemotherapy
  • Primary language other than English or Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breastfeeding video
Participants randomized to this arm view the intervention video - Injoy Videos Better Breastfeeding video.
Behavioral: Prenatal video
Participants are randomized to view either the intervention video or a sham video.
Other Names:
  • Injoy videos
Placebo Comparator: Sham video
Participants randomized to this arm view the sham video Injoy Videos Your Healthy Pregnancy: Prenatal Nutrition and Exercise video.
Behavioral: Prenatal video
Participants are randomized to view either the intervention video or a sham video.
Other Names:
  • Injoy videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding
Time Frame: 6 months post-partum
To determine the effect of the intervention on the initiation, duration, and exclusivity of breastfeeding among low-income, WIC-eligible women.
6 months post-partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant feeding practices for women that deliver prior to 35 weeks gestation
Time Frame: Six months post-partum
To determine the effect of the intervention on infant feeding practices immediately postpartum among women who deliver their babies prior to 35 weeks of gestation.
Six months post-partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Virginia Department of Health

Investigators

  • Principal Investigator: Ann Kellams, MD, University of Virginia School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

December 20, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14812

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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