Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
522 participants
INTERVENTIONAL
2010-03-31
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Breastfeeding video
Participants randomized to this arm view the intervention video - Injoy Videos Better Breastfeeding video.
Prenatal video
Participants are randomized to view either the intervention video or a sham video.
Sham video
Participants randomized to this arm view the sham video Injoy Videos Your Healthy Pregnancy: Prenatal Nutrition and Exercise video.
Prenatal video
Participants are randomized to view either the intervention video or a sham video.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prenatal video
Participants are randomized to view either the intervention video or a sham video.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Known contraindication to breastfeeding Illicit drug use HIV + Recipient of chemotherapy
* Primary language other than English or Spanish
15 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Virginia Department of Health
OTHER_GOV
University of Virginia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ann Kellams, MD
Prinicpal Investigaor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ann Kellams, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14812
Identifier Type: -
Identifier Source: org_study_id