A Pilot Study Assessing the Feasibility and Effectiveness of a Breastfeeding Educational Video on Breastfeeding Rates

Breastfeeding, Exclusive Clinical Trial

Official title:

A Pilot Study Assessing the Feasibility and Effectiveness of an Antepartum Breastfeeding Educational Video on In-Hospital and 6 Month Exclusive Breastfeeding Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692480
• Other study ID #: 1539297
• Status: Completed
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: May 21, 2022

Study information

• Verified date: April 2023
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 21, 2022
• Est. primary completion date: May 21, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breastfeeding, Exclusive

Intervention

Behavioral:
• Breastfeeding Video Education
Video entitled "Breastfeeding in the First Hour, It's in Your Hands"
• Breastfeeding PDF education
PDF of standard breastfeeding education handouts

Locations

Country	Name	City	State
United States	Women and Infants Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Breastfeeding rates at 6 weeks postpartum	Using a self reported phone survey of infant feeding practices including exclusive breastfeeding, inclusively breastfeeding with formula supplementation, formula feeding only, or solid food supplementation, 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 6 weeks postpartum.	6 weeks postpartum
Secondary	Breastfeeding rates at 3 months postpartum	Using a self reported phone survey of infant feeding practices including exclusive breastfeeding, inclusively breastfeeding with formula supplementation, formula feeding only, or solid food supplementation, 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 3 months postpartum.	3 months postpartum
Secondary	Breastfeeding rates at 6 months postpartum	Using a self reported phone survey of infant feeding practices including exclusive breastfeeding, inclusively breastfeeding with formula supplementation, formula feeding only, or solid food supplementation, 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 6 months postpartum.	6 months postpartum
Secondary	Maternal perceptions of acceptability of breastfeeding education interventions	To determine if women find breastfeeding educational interventions during delivery hospitalization to be acceptable and helpful Using a self reported survey of women's experience with breastfeeding support resources during hospital admission, the investigators aim to determine if the video or control education was acceptable and helpful to participants. Outcome will be measured on the Likert scale from 1 (not helpful at all) to 5 (very helpful).	1-4 days Postpartum

External Links

•   Breastfeeding educational Video "Breastfeeding in the First Hour, It's in Your Hands" in English
•   Breastfeeding educational Video "Breastfeeding in the First Hour, It's in Your Hands" in Spanish