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Prenatal Education Video Study

Prenatal Education Video Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01623128
Acronym
PEVS
Enrollment
522
Registered
2012-06-19
Start date
2010-03-31
Completion date
2013-07-31
Last updated
2013-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Keywords

Breastfeeding initiation, Breastfeeding duration, WIC, Video education, Breastfeeding rates

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.

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.

Interventions

BEHAVIORALPrenatal video

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

Sponsors

Virginia Department of Health
CollaboratorOTHER_GOV
University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Breastfeeding6 months post-partumTo determine the effect of the intervention on the initiation, duration, and exclusivity of breastfeeding among low-income, WIC-eligible women.

Secondary

MeasureTime frameDescription
Infant feeding practices for women that deliver prior to 35 weeks gestationSix months post-partumTo determine the effect of the intervention on infant feeding practices immediately postpartum among women who deliver their babies prior to 35 weeks of gestation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026