Breastfeeding, ExclusiveNCT04692480
A Pilot Study Assessing the Feasibility and Effectiveness of a Breastfeeding Educational Video on Breastfeeding Rates
A study testing Breastfeeding Video Education and Breastfeeding PDF education in people with Breastfeeding, Exclusive, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breastfeeding, Exclusive
- What is being tested?
- Breastfeeding Video Education and Breastfeeding PDF education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2020to 21 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants Hospital
Providence, Rhode Island, 02920
About this study
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
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.
- Conditions
- Breastfeeding, Exclusive
- Being tested
- Breastfeeding Video Education, Breastfeeding PDF education
- Keywords
- Breastfeeding, Video education, Exclusive breastfeeding, Milk supply, Breastfeeding efficiency, Patient education, Antepartum
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding Video EducationBehavioural
Video entitled "Breastfeeding in the First Hour, It's in Your Hands"
Breastfeeding PDF educationBehavioural
PDF of standard breastfeeding education handouts
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding Video Education | Experimental | Participants will view a breastfeeding educational video entitled "Breastfeeding in the First Hour, It's in Your Hands." Receives: Behavioral: Breastfeeding Video Education |
| Control | Other | Participants will view a PDF of breastfeeding education materials available for inclusion in standard discharge paper work. Receives: Behavioral: Breastfeeding PDF education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1-4 days Postpartum
Secondary outcomes (4)
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.
Measured: 6 weeks postpartum
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.
Measured: 3 months postpartum
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.
Measured: 6 months postpartum
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).
Measured: 1-4 days Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start22 Dec 2020
- Primary completion21 May 2022
- Study completion21 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurie Griffin, Women and Infants Hospital of Rhode Island
- Investigators
- Laurie B Griffin, MD/PhD, Principal investigator, Women and Infants Hospital/Brown Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692480
- Sponsor's protocol ID
- 1539297
- Status last verified
- Apr 2023
- First submitted
- 17 Dec 2020
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a pilot study, we do not plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04692480
- Acronym / sponsor ID
- 1539297
- Conditions
- Breastfeeding, Exclusive
- Keywords
- Breastfeeding, Video education, Exclusive breastfeeding, Milk supply, Breastfeeding efficiency, Patient education, Antepartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 21 May 2022 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Video Education | Experimental | Behavioral: Breastfeeding Video EducationParticipants will view a breastfeeding educational video entitled "Breastfeeding in the First Hour, It's in Your Hands." |
| Control | Other | Behavioral: Breastfeeding PDF educationParticipants will view a PDF of breastfeeding education materials available for inclusion in standard discharge paper work. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding Video EducationVideo entitled "Breastfeeding in the First Hour, It's in Your Hands" | Behavioural | Breastfeeding Video Education |
| Breastfeeding PDF educationPDF of standard breastfeeding education handouts | Behavioural | Control |
Primary outcome
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.
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.
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.
4 secondary outcomes
Breastfeeding rates at 6 weeks postpartum
Time frame: 6 weeks postpartum
Breastfeeding rates at 3 months postpartum
Time frame: 3 months postpartum
Breastfeeding rates at 6 months postpartum
Time frame: 6 months postpartum
Maternal perceptions of acceptability of breastfeeding education interventions
Time frame: 1-4 days Postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Breastfeeding educational Video "Breastfeeding in the First Hour, It's in Your Hands" in EnglishLink provided by the sponsor.
- Breastfeeding educational Video "Breastfeeding in the First Hour, It's in Your Hands" in SpanishLink provided by the sponsor.
- Individual participant dataSharing planned: No. As this is a pilot study, we do not plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie B Griffin, MD/PhD principal investigator
Women and Infants Hospital/Brown Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Video Education and Breastfeeding PDF education in people with Breastfeeding, Exclusive, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding rates at hospital discharge (time frame: 1-4 days Postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.