Clinical trial NCT01623128: Prenatal Education Video Study
Official title: Prenatal Education Video Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding initiation
Breastfeeding duration
WIC
Video education
Breastfeeding rates
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Virginia Department of Health
First posted: 2012-06-19
Enrollment: 522
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Breastfeeding
timeFrame: 6 months post-partum
Secondary outcomes:
measure: Infant feeding practices for women that deliver prior to 35 weeks gestation
timeFrame: Six months post-partum
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: University of Virginia School of Medicine
name: Ann Kellams, MD
role: PRINCIPAL_INVESTIGATOR
References: