Prenatal Education Video Study

Breastfeeding Clinical Trial

— PEVS  

Official title:

Prenatal Education Video Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623128
• Other study ID #: 14812
• Status: Completed
• Phase: N/A
• First received: June 15, 2012
• Last updated: December 18, 2013
• Start date: March 2010
• Est. completion date: July 2013

Study information

• Verified date: December 2013
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• Prenatal video
Participants are randomized to view either the intervention video or a sham video.

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Virginia Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Infant feeding practices for women that deliver prior to 35 weeks gestation	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	No