An interventional study of Prenatal video in Breastfeeding, sponsored by University of Virginia. Completed at 2 sites in United States. Open to female participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2013-12-20.
Sponsored by University of Virginia · Not applicable, Interventional, and Health services research
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.
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.
289 studies on the registry are indexed under Breast Feeding; 119 are open to participants now.
This study's enrollment of 522 is above the median of 97 across 228 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →University of Virginia is the lead sponsor of 672 studies on the registry; 138 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
Participants randomized to this arm view the intervention video - Injoy Videos Better Breastfeeding video.
Behavioral: Prenatal video
Participants randomized to this arm view the sham video Injoy Videos Your Healthy Pregnancy: Prenatal Nutrition and Exercise video.
Behavioral: Prenatal video
Participants are randomized to view either the intervention video or a sham video.
Also known as: Injoy videos
Breastfeeding
To determine the effect of the intervention on the initiation, duration, and exclusivity of breastfeeding among low-income, WIC-eligible women.
Time frame: 6 months post-partum
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.
Time frame: Six months post-partum
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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