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

• ClinicalTrials.gov Identifier: NCT04692480
• Recruitment Status: Active, not recruiting
• First Posted: December 31, 2020
• Last Update Posted: August 10, 2021
• Sponsor: Women and Infants Hospital of Rhode Island
• Information provided by (Responsible Party): Laurie Griffin, Women and Infants Hospital of Rhode Island

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breastfeeding, Exclusive	Behavioral: Breastfeeding Video Education; Behavioral: Breastfeeding PDF education	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Nulliparous women planning to exclusively breastfeed will be consented and will complete a survey regarding demographics and breastfeeding education experience. Participants will be randomized to viewing a standard breastfeeding education PDF (Control) or to watching an educational video entitled "Breastfeeding in the First Hour, It's in Your Hands"(Intervention group). Both activities will occur on a tablet. Participants will undergo routine intrapartum care. On the day of discharge, patient's will complete a survey that includes the Breastfeeding Self-Efficiency Scale-Short Form, the Perception of Insufficient Milk Questionnaire, and questions regarding in hospital breastfeeding educational experiences. Data will be compared between the two groups to determine if antepartum video education improved perception of breast milk supply and efficiency and increases exclusive breastfeeding rates. At 6 months postpartum, women will be surveyed by phone regarding their breastfeeding status.
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Other
• 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
• Actual Study Start Date: December 22, 2020
• Estimated Primary Completion Date: December 21, 2021
• Estimated Study Completion Date: July 22, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Breastfeeding Video Education; Participants will view a breastfeeding educational video entitled "Breastfeeding in the First Hour, It's in Your Hands."	Behavioral: Breastfeeding Video Education; Video entitled "Breastfeeding in the First Hour, It's in Your Hands"
Control; Participants will view a PDF of breastfeeding education materials available for inclusion in standard discharge paper work.	Behavioral: Breastfeeding PDF education; PDF of standard breastfeeding education handouts

Outcome Measures

Primary Outcome Measures :

1. Breastfeeding rates at hospital discharge [ Time Frame: 1-4 days Postpartum ]
   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.
2. Maternal perception of breastfeeding efficiency at hospital discharge [ Time Frame: 1-4 days Postpartum ]
   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.
3. Maternal perception of milk supply at hospital discharge [ Time Frame: 1-4 days Postpartum ]
   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.

Secondary Outcome Measures :

1. Breastfeeding rates at 6 weeks postpartum [ Time Frame: 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.
2. Breastfeeding rates at 3 months postpartum [ Time Frame: 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. Breastfeeding rates at 6 months postpartum [ Time Frame: 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.
4. Maternal perceptions of acceptability of breastfeeding education interventions [ Time Frame: 1-4 days Postpartum ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Rhode Island

Women and Infants Hospital

Providence, Rhode Island, United States, 02920

Sponsors and Collaborators

Women and Infants Hospital of Rhode Island

Investigators

• Principal Investigator: Laurie B Griffin, MD/PhD; Women and Infants Hospital/Brown Univerisity

More Information

Additional Information:

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 

• Responsible Party: Laurie Griffin, Obstetrics and Gynecology House Officer, Women and Infants Hospital of Rhode Island
• ClinicalTrials.gov Identifier: NCT04692480
• Other Study ID Numbers: 1539297
• First Posted: December 31, 2020
• Last Update Posted: August 10, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: As this is a pilot study, we do not plan to make IPD available.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laurie Griffin, Women and Infants Hospital of Rhode Island:

Breastfeeding; Video education; Exclusive breastfeeding; Milk supply; Breastfeeding efficiency; Patient education; Antepartum