A Pilot Study Assessing the Feasibility and Effectiveness of a Breastfeeding Educational Video on Breastfeeding Rates
1 other identifier
interventional
66
1 country
1
Brief Summary
Given the known health benefits of breast milk, the World Health Organization and pediatric and obstetrical professional societies all recommend that babies only consume breast milk (also referred to as "exclusive breastfeeding (EBF)") through 6 months of age. While many women initiate breastfeeding while at the study institution hospital, the rate of exclusive breastfeeding when mothers and babies are discharged is only 34%. Sixty percent of mothers stopped breastfeeding earlier than intended to primarily due to concerns about difficulty with lactation (i.e. sore nipples, inadequate milk supply), baby's nutrition (i.e weight gain and satiety) and effort required to pump breast milk. It is known that prenatal education by trained health care providers is effective in increasing EBF rates; however, these interventions are time and labor intensive and require employment of breastfeeding specialists. Therefore, a simple, brief, easily accessible breastfeeding education tool is needed to directly educated new mothers on how to breastfeed and what the actual nutritional needs of an infant are in order to support women's breastfeeding goals. The objective of this study is to assess whether a simple breastfeeding education video viewed at the time of admission to the hospital for delivery will increase EBF at the time of hospital discharge through 6 months postpartum by improving women's perception of their milk supply and their breast feeding efficiency. The investigators predict that woman who view a short breastfeeding education video just prior to delivery will have an improved perception of their breastfeeding efficiency and milk supply and will be more likely to avoid formula use while admitted to the hospital and though 6 months postpartum. In this study, the investigators will randomly assign women to view an educational video focused on breastfeeding in the first days of a baby's life and compare them to women who receive the standard educational pamphlet on breastfeeding given to all women delivering at the study institution. The investigators will then survey each participant after her delivery on how she is feeding her baby (breast milk, formula, or both) and how she perceives her milk supply and breastfeeding efficiency just before she is discharged from the hospital. The investigators will then call women on the phone at 6 weeks, 3 months and 6 months to reassess how they are feeding their babies (breast milk, formula or both). In addition to baseline characteristics about the individuals such as age, race, and employment status, information regarding their pregnancy and delivery will be obtained to assess for any confounding factors that may effect their ability to breastfeed. This research will help determine if video education can provide sufficient education to help increase breastfeeding rates. Additionally, this research may inform the research community on the overall effectiveness of video education in healthcare, allowing for a similar approach to be used for other educational initiatives.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2020
CompletedStudy Start
First participant enrolled
December 22, 2020
CompletedFirst Posted
Study publicly available on registry
December 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2022
CompletedApril 28, 2023
April 1, 2023
1.4 years
December 17, 2020
April 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Breastfeeding rates at hospital discharge
Using a self reported survey of infant feeding practices including exclusive breastfeeding, breastfeeding with formula supplementation or formula feeding only, the investigators aim to determine if participants who viewed the breastfeeding education video had increased breastfeeding rates compared to women who viewed the control PDF materials at time of hospital discharge.
1-4 days Postpartum
Maternal perception of breastfeeding efficiency at hospital discharge
Using the validated Breastfeeding Self-Efficiency Scale-Short Form, a Likert scale survey ranging from 1 (not confident at all) to 5 (very confident), the investigators aim to determine if maternal perception of breastfeeding efficiency at time of hospital discharge is increased for women who viewed the breastfeeding video compared to those who viewed the control PDF materials.
1-4 days Postpartum
Maternal perception of milk supply at hospital discharge
Using the validated Perception of Insufficient Milk Questionnaire, a Likert scale survey ranging from 1 (strongly disagree) to 10 (strongly agree) the investigators aim to determine if maternal perception of milk supply at time of hospital discharge is increased for women who viewed the breastfeeding video compared to those who viewed the control PDF materials. Outcome will be measured on the Likert scale.
1-4 days Postpartum
Secondary Outcomes (4)
Breastfeeding rates at 6 weeks postpartum
6 weeks postpartum
Breastfeeding rates at 3 months postpartum
3 months postpartum
Breastfeeding rates at 6 months postpartum
6 months postpartum
Maternal perceptions of acceptability of breastfeeding education interventions
1-4 days Postpartum
Study Arms (2)
Breastfeeding Video Education
EXPERIMENTALParticipants will view a breastfeeding educational video entitled "Breastfeeding in the First Hour, It's in Your Hands."
Control
OTHERParticipants will view a PDF of breastfeeding education materials available for inclusion in standard discharge paper work.
Interventions
Video entitled "Breastfeeding in the First Hour, It's in Your Hands"
Eligibility Criteria
You may qualify if:
- nulliparous woman
- \>18 years of age
- Fluency in English or Spanish
- Intention to exclusively breastfeed
- Admitted to Women and Infants Hospital (Providence, RI) for induction of labor, labor, or primary cesarean delivery.
- Gestational age between 37'0-42'0
You may not qualify if:
- Prior breastfeeding experience (ex: induced lactation for prior child)
- Contraindications to breastfeeding,
- Intention to utilize formula
- Extremis prohibiting consent
- Women who require Intensive Care Unit (ICU) admission, whose infants require Neonatal Intensive Care Unit (NICU) admission, or who suffer an intrapartum fetal demise or neonatal death will be excluded from final analysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women and Infants Hospital
Providence, Rhode Island, 02920, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurie B Griffin, MD/PhD
Women and Infants Hospital/Brown Univerisity
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Obstetrics and Gynecology House Officer
Study Record Dates
First Submitted
December 17, 2020
First Posted
December 31, 2020
Study Start
December 22, 2020
Primary Completion
May 21, 2022
Study Completion
May 21, 2022
Last Updated
April 28, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
As this is a pilot study, we do not plan to make IPD available.