Prenatal Education Video Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prenatal Education Video Study

Conditions
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Breastfeeding

Intervention / Treatment
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* Behavioral: Prenatal video


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breastfeeding video<br>Participants randomized to this arm view the intervention video - Injoy Videos Better Breastfeeding video. | Behavioral: Prenatal video<br>* Participants are randomized to view either the intervention video or a sham video.<br>* Other names: Injoy videos;|
| Placebo Comparator: Sham video<br>Participants randomized to this arm view the sham video Injoy Videos Your Healthy Pregnancy: Prenatal Nutrition and Exercise video. | Behavioral: Prenatal video<br>* Participants are randomized to view either the intervention video or a sham video.<br>* Other names: Injoy videos;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding initiation, Breastfeeding duration, WIC, Video education, Breastfeeding rates