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Completed

NCT Number: NCT01623128

Prenatal Education Video Study

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.

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Key information

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Health System, Charlottesville, Virginia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prenatal video

Behavioral

Participants are randomized to view either the intervention video or a sham video.

Other names: Injoy videos

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Virginia Department of Health

Registry information

Acronym: PEVS

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 19, 2012
Registry last updated
Dec 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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