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

April 26, 2023 updated by: Laurie Griffin, Women and Infants Hospital of Rhode Island

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02920
        • Women and Infants Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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"
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-4 days Postpartum
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.
1-4 days Postpartum
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.
1-4 days Postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks postpartum
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 months postpartum
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.
6 months postpartum
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).
1-4 days Postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women and Infants Hospital of Rhode Island

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2020

Primary Completion (Actual)

May 21, 2022

Study Completion (Actual)

May 21, 2022

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 31, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1539297

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As this is a pilot study, we do not plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breastfeeding, Exclusive

Clinical Trials on Breastfeeding Video Education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe