Prenatal Education Video Study
PEVS
1 other identifier
interventional
522
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 15, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedDecember 20, 2013
December 1, 2013
3.2 years
June 15, 2012
December 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Breastfeeding
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 Outcomes (1)
Infant feeding practices for women that deliver prior to 35 weeks gestation
Six months post-partum
Study Arms (2)
Breastfeeding video
EXPERIMENTALParticipants randomized to this arm view the intervention video - Injoy Videos Better Breastfeeding video.
Sham video
PLACEBO COMPARATORParticipants randomized to this arm view the sham video Injoy Videos Your Healthy Pregnancy: Prenatal Nutrition and Exercise video.
Interventions
Participants are randomized to view either the intervention video or a sham video.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Multiple gestation
- Known contraindication to breastfeeding Illicit drug use HIV + Recipient of chemotherapy
- Primary language other than English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- Virginia Department of Healthcollaborator
Study Sites (2)
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University
Richmond, Virginia, 23284, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Kellams, MD
University of Virginia School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicpal Investigaor
Study Record Dates
First Submitted
June 15, 2012
First Posted
June 19, 2012
Study Start
March 1, 2010
Primary Completion
May 1, 2013
Study Completion
July 1, 2013
Last Updated
December 20, 2013
Record last verified: 2013-12