Breast FeedingNCT04549129
Prenatal Breastfeeding Education
A study testing Breastfeeding education video, Breastfeeding website and Usual breastfeed education in people with Breast Feeding, run by Boston Medical Center at 1 site in United States.
Trial summary
In this pilot randomized control trial, the investigators will evaluate the feasibility and acceptability of using a video and website in a prenatal visit to provide breastfeeding education, focusing on how to hand express (HE) breast milk. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Breastfeeding education video, Breastfeeding website and Usual breastfeed education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2021to Nov 2023
- 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
- Pregnant
- Receiving prenatal care at Manet Community Health Center
- Speaks and understands English
- Infants born to the included adult subjects (infants are subjects for chart review only)
Who cannot join
- Contraindication to breastfeeding (HIV positive or active substance use disorder)
- Fetal demise or neonatal death (after patient is consented into the study)
- Severe maternal illness significant limiting ability to perform hand expression (e.g. admission to ICU during admission for labor and delivery)
Trial locations and contacts
1 site in 1 country.
United States1 site
Manet Community Health Center
Quincy, Massachusetts, 02171
About this study
Official title: First Droplets: Feasibility Randomized Controlled Trial of Prenatal Breastfeeding Education
In this pilot randomized control trial, the investigators will evaluate the feasibility and acceptability of using a video and website in a prenatal visit to provide breastfeeding education, focusing on how to hand express (HE) breast milk. Participants will be randomized to the video/website intervention group or to the control standard of care group. After delivery, participants will be asked to provide information on how long they breastfed and if they used the information in the video and website. Differences in the outcome measures will be analyzed between the two groups.
Read the detailed description
This study aims to evaluate the feasibility of a new method for teaching breastfeeding skills, and may provide evidence that hand expression (HE) to augment milk production in the first days postpartum can help women breastfeed. Few studies have evaluated the use of HE for improving breastfeeding outcomes. This study will also evaluate the impact of a new video/website which can be utilized widely and adapted for other populations, both in clinical and non-clinical settings.
Prenatal patients receiving care at a community health center in the Boston area will be invited to participate in the study at approximately 28 weeks gestation.
Participants will complete a baseline questionnaire prior to randomization which will occur at the ~36 week prenatal visit. A 1:1 randomization schedule will be applied.
Control arm: participants will be given usual care handouts and the study provider will provide anticipatory guidance and offer to answer any questions about breastfeeding.
Intervention arm: participants will be shown the breastfeeding education video on a study tablet, and provided a QR code which will give them access to the associated website. After watching the video, study staff will then offer to review hand expression by answering questions and reviewing steps, and physically helping the patient to practice hand expression. Hands-on teaching of hand expression will be opt-in only and not required for study participation.
Text messages will be sent to the intervention arm participants with the link to the intervention video and website, and a brief message reminding them to review the materials and to hand express frequently starting immediately after delivery.
All participants (both arms) will be contacted to fill out a very brief, 10-item questionnaire (approximately 5 minutes) at 3 days postpartum, and short questionnaires (10-15 minutes) at 14 days and 60 days postpartum. Questionnaires will ask about use of hand expression, breastfeeding, formula use, perceived breastfeeding problems, breastfeeding efficacy and satisfaction with prenatal breastfeeding education. In all questionnaires participants will be asked about pain and potential adverse events.
Participant and neonatal electronic medical records will reviewed through 2 months postpartum.
- Conditions
- Breast Feeding
- Being tested
- Breastfeeding education video, Breastfeeding website, Usual breastfeed education
- Keywords
- Video education, Hand expression of breast milk, Community health center
- 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 education videoBehavioural
An introductory video (15 minutes) gives an overview of these "ABCs" (video titled "Term baby" which are further taught through brief text summaries (150-200 words) and short instructional videos (2-6 minutes).
Breastfeeding websiteBehavioural
The website firstdroplets.com is designed for prenatal education, focusing on the "ABCs of breastfeeding that come before D (delivery)" - attachment (latch), breastmilk production, and calories (transfer of milk to baby).
Usual breastfeed educationBehavioural
The usual breastfeed education includes brief counseling by study staff and provision of handouts on latch/positioning and common first week breastfeeding advice
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants randomized to the intervention group will receive breastfeeding education and teaching of hand expression using a breastfeeding education video and associated breastfeeding website, as well as hands-on teaching of hand expression techniques during their 36 week visit. Receives: Behavioral: Breastfeeding education video; Behavioral: Breastfeeding website |
| Control group | Active comparator | Participants randomized to the control group will receive usual breastfeeding education during their 36-week visit. Receives: Behavioral: Usual breastfeed education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion using hand expression
Proportion of respondents who have performed hand expression since their baby was born
Measured: 3 days post partum
Mean times hand expression in past 24 hours
Mean number of times performed hand expression in past 24 hours
Measured: 3 days post partum
Mean hand expression experience scale
Mean score on the following set of questions (adapted from the Breast Milk Expression Experience measure):
How much do you agree with the following? (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree)
- My family members support hand expression.
- My partner supports hand expression.
- I feel peaceful when hand expressing.
- I look forward to hand expressing.
- I enjoy hand expressing.
- Hand expressing is something I could do easily while doing other things.
- Hand expressing feels awkward.
- Hand expression makes me feel confident my baby is getting enough milk
Measured: 3 days post partum
Secondary outcomes (6)
Proportion exclusively breastfeeding
Proportion who report only giving breastmilk within the past 24 hours
Measured: 2 months
Proportion any breastfeeding
Proportion who report giving any breastmilk within the past 24 hours
Measured: 2 months
Breast feeding self-efficacy
Breast feeding confidence will be assessed using the Breastfeeding Self-Efficacy Scale Short form (BSES-SF) is a 14-item self-administered instrument derived from the original 33-item BSES that measures breastfeeding confidence. All items are preceded by the phrase ''I can always'' and rated on a 5-point Likert scale, ranging from 1 (not at all confident) to 5 (always confident). Scores can range form 14 to 70 and higher scores are associated with higher levels of breast feeding confidence.
Measured: 14 days
Proportion with concern for low milk production
Proportion of mothers who report concern for low milk production
Measured: 14 days
Hand expression comprehension
Proportion of correct comprehension of hand expression technique and application after viewing video
Measured: 36 weeks gestation
Satisfaction with video
Mean reported satisfaction with intervention video, on Likert scale (1=Strongly disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Strongly agree)
Measured: 36 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start24 Jun 2021
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: This pilot study was planned just prior to and during the covid-19 pandemic and was not able to begin due to changes in staffing availability and clinic logistics during the pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Standish, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549129
- Sponsor's protocol ID
- H-39614
- Status last verified
- Nov 2023
- First submitted
- 9 Sep 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Droplets: Feasibility Randomized Controlled Trial of Prenatal Breastfeeding Education
- ClinicalTrials.gov ID
- NCT04549129
- Acronym / sponsor ID
- H-39614
- Conditions
- Breast Feeding
- Keywords
- Video education, Hand expression of breast milk, Community health center
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This pilot study was planned just prior to and during the covid-19 pandemic and was not able to begin due to changes in staffing availability and clinic logistics during the pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 16 Sep 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.
In this pilot randomized control trial, the investigators will evaluate the feasibility and acceptability of using a video and website in a prenatal visit to provide breastfeeding education, focusing on how to hand express (HE) breast milk. Participants will be randomized to the video/website intervention group or to the control standard of care group. After delivery, participants will be asked to provide information on how long they breastfed and if they used the information in the video and website. Differences in the outcome measures will be analyzed between the two groups.
Detailed description
This study aims to evaluate the feasibility of a new method for teaching breastfeeding skills, and may provide evidence that hand expression (HE) to augment milk production in the first days postpartum can help women breastfeed. Few studies have evaluated the use of HE for improving breastfeeding outcomes. This study will also evaluate the impact of a new video/website which can be utilized widely and adapted for other populations, both in clinical and non-clinical settings.
Prenatal patients receiving care at a community health center in the Boston area will be invited to participate in the study at approximately 28 weeks gestation.
Participants will complete a baseline questionnaire prior to randomization which will occur at the ~36 week prenatal visit. A 1:1 randomization schedule will be applied.
Control arm: participants will be given usual care handouts and the study provider will provide anticipatory guidance and offer to answer any questions about breastfeeding.
Intervention arm: participants will be shown the breastfeeding education video on a study tablet, and provided a QR code which will give them access to the associated website. After watching the video, study staff will then offer to review hand expression by answering questions and reviewing steps, and physically helping the patient to practice hand expression. Hands-on teaching of hand expression will be opt-in only and not required for study participation.
Text messages will be sent to the intervention arm participants with the link to the intervention video and website, and a brief message reminding them to review the materials and to hand express frequently starting immediately after delivery.
All participants (both arms) will be contacted to fill out a very brief, 10-item questionnaire (approximately 5 minutes) at 3 days postpartum, and short questionnaires (10-15 minutes) at 14 days and 60 days postpartum. Questionnaires will ask about use of hand expression, breastfeeding, formula use, perceived breastfeeding problems, breastfeeding efficacy and satisfaction with prenatal breastfeeding education. In all questionnaires participants will be asked about pain and potential adverse events.
Participant and neonatal electronic medical records will reviewed through 2 months postpartum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Breastfeeding education video, Behavioral: Breastfeeding websiteParticipants randomized to the intervention group will receive breastfeeding education and teaching of hand expression using a breastfeeding education video and associated breastfeeding website, as well as hands-on teaching of hand expression techniques during their 36 week visit. |
| Control group | Active comparator | Behavioral: Usual breastfeed educationParticipants randomized to the control group will receive usual breastfeeding education during their 36-week visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant
- Receiving prenatal care at Manet Community Health Center
- Speaks and understands English
- Infants born to the included adult subjects (infants are subjects for chart review only)
Key exclusion criteria (3 listed)
- Contraindication to breastfeeding (HIV positive or active substance use disorder)
- Fetal demise or neonatal death (after patient is consented into the study)
- Severe maternal illness significant limiting ability to perform hand expression (e.g. admission to ICU during admission for labor and delivery)
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 education videoAn introductory video (15 minutes) gives an overview of these "ABCs" (video titled "Term baby" which are further taught through brief text summaries (150-200 words) and short instructional videos (2-6 minutes). | Behavioural | Intervention group |
| Breastfeeding websiteThe website firstdroplets.com is designed for prenatal education, focusing on the "ABCs of breastfeeding that come before D (delivery)" - attachment (latch), breastmilk production, and calories (transfer of milk to baby). | Behavioural | Intervention group |
| Usual breastfeed educationThe usual breastfeed education includes brief counseling by study staff and provision of handouts on latch/positioning and common first week breastfeeding advice | Behavioural | Control group |
Primary outcome
Proportion using hand expression
Time frame: 3 days post partum
Proportion of respondents who have performed hand expression since their baby was born
Mean times hand expression in past 24 hours
Time frame: 3 days post partum
Mean number of times performed hand expression in past 24 hours
Mean hand expression experience scale
Time frame: 3 days post partum
Mean score on the following set of questions (adapted from the Breast Milk Expression Experience measure): How much do you agree with the following? (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree) 1. My family members support hand expression. 2. My partner supports hand expression. 3. I feel peaceful when hand expressing. 4. I look forward to hand expressing. 5. I enjoy hand expressing. 6. Hand expressing is something I could do easily while doing other things. 7. Hand expressing feels awkward. 8. Hand expression makes me feel confident my baby is getting enough milk
6 secondary outcomes
Proportion exclusively breastfeeding
Time frame: 2 months
Proportion any breastfeeding
Time frame: 2 months
Breast feeding self-efficacy
Time frame: 14 days
Proportion with concern for low milk production
Time frame: 14 days
Hand expression comprehension
Time frame: 36 weeks gestation
Satisfaction with video
Time frame: 36 weeks gestation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Katherine Standish, MD principal investigator
Boston Medical Center
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 education video, Breastfeeding website and Usual breastfeed education in people with Breast Feeding, run by Boston Medical Center 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 30 Nov 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion using hand expression (time frame: 3 days post partum). 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 30 Nov 2023.