BreastfeedingNCT04856163
The Impact of Telelactation Services on Breastfeeding Outcomes
A study testing Telelactation support in people with Breastfeeding, run by RAND at 1 site in United States.
Trial summary
This project will assess the impact of a novel breastfeeding support intervention ("telelactation"), delivered via video calls on personal devices including mobile phones and tablets. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Telelactation support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,108 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ≥ 18 years of age
- pregnant with first child
- intend to attempt breastfeeding
- residing in a state underserved by IBCLCs
Who cannot join
- non-singleton pregnancy
- advised by healthcare provider not to breastfeed for a medical reason (e.g., HIV+ status, chemotherapy planned)
- in police custody or incarcerated
- infant to be separated from birthing parent (e.g., given up for adoption, military deployment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Telelactation Services on Breastfeeding Outcomes: Digital Tele-MILC Trial
This project will assess the impact of a novel breastfeeding support intervention ("telelactation"), delivered via video calls on personal devices including mobile phones and tablets. The goal of this intervention is to increase access to International Board Certified Lactation Consultants to improve, and reduce disparities in, breastfeeding rates. By implementing a digital randomized controlled trial that recruits participants through a popular pregnancy tracker mobile phone application, this mixed methods study will recruit a national sample of 1800-2400 individuals (depending on rate of attrition) during their third trimester of pregnancy to 1) provide evidence on the effectiveness of a widely available, yet understudied, service and 2) leverage technology to promote one of the most widely recommended health behaviors to improve children's health and to reduce disparities in key maternal and child health outcomes.
Read the detailed description
This study is a pragmatic, parallel design randomized controlled trial that will generate evidence on the impact of telelactation on breastfeeding duration and exclusivity and explore differences in effectiveness by race/ethnicity. The study is mixed methods, and uses a sequential explanatory design in which qualitative interviews are used to explain and contextualize findings from the quantitative outcomes analysis. We will recruit primiparous, pregnant individuals age > 18 who intend to breastfeed and live in states most underserved by IBCLCs. Recruitment will occur via Ovia, a pregnancy tracker mobile phone application (app) used by one million pregnant individuals in the U.S. annually. Participants will be randomized to: 1) on-demand telelactation video calls on personal devices or 2) ebook on infant care/usual care. Breastfeeding outcomes will be captured via surveys and interviews and compared across racial and ethnic groups. This study will track participants for eight months (including six months postpartum), generating 1) quantitative data on the impact of telelactation and differences in effectiveness across racial and ethnic minority groups; and 2) rich qualitative data on the experiences of different subgroups of parents with the intervention, including barriers to use, satisfaction, and strengths and limitations of this delivery model.
- Conditions
- Breastfeeding
- Being tested
- Telelactation support
- Keywords
- telehealth, telemedicine, health equity, disparities, breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telelactation supportBehavioural
Participants will get unlimited access (through 24 weeks postpartum) to video calls with lactation consultants who are available 24/7. Participants can use the service as demanded.
| Study group | Role | What they receive |
|---|---|---|
| Telelactation support | Experimental | Participants in the experimental group will receive unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services will be available through mobile phone app. Receives: Behavioral: Telelactation support |
| ebook | No intervention | Participants in the control arm will receive care as usual. They will also receive a ebook with content on infant care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Duration 1
Number of participants who report any breastfeeding at 6 months
Measured: 6 months postpartum
Breastfeeding Duration 2
Time to cessation of breastfeeding in months (as measured by reported age of infant when completely stopped receiving breastmilk)
Measured: 6 months post-partum
Breastfeeding Exclusivity
Number of participants who report no formula use at 6 months
Measured: 6 months postpartum
Secondary outcomes (1)
Breastfeeding Satisfaction
Breastfeeding satisfaction at 6 months postpartum. Score on five-item maternal/infant breastfeeding satisfaction scale (which is a subscale of the Hill and Humenick lactation scale). Higher values indicate more agreement with the measures of satisfaction, resulting in a composite satisfaction score ranging from 5 to 25 for the subscale.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start8 Jul 2021
- Primary completion30 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 2,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856163
- Sponsor's protocol ID
- R01NR018837
- Status last verified
- Dec 2024
- First submitted
- 19 Apr 2021
- Last updated
- 3 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data resulting from the proposed research will be shared with external researchers who request access beginning one year after the project ends. Results will be available to other researchers, public health workers, healthcare professionals, and community leaders who are interested in exploring approaches to improving breastfeeding rates following a brief application process. Constraints imposed by human research subjects protection regulations (e.g., HIPAA Protected Health Information) and RAND's IRB will be recognized as allowed by NIH. External researchers interested in investigator data, survey instruments, and other research methodology and procedures will obtain this information through collaborative agreements (e.g., data use agreements) with the principal investigator and co-investigators, as required by NIH's data sharing policy.
Publications
Uscher-Pines L, Kapinos K, Waymouth M, Howell K, Alvarado G, Ray K, Demirci J, Mehrotra A, Rogers R, James KF, DeYoreo M. Telelactation Services and Breastfeeding by Race and Ethnicity: A Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2461958. doi: 10.1001/jamanetworkopen.2024.61958.
PubMed 40014345Uscher-Pines L, Demirci J, Waymouth M, Lawrence R, Parks A, Mehrotra A, Ray K, DeYoreo M, Kapinos K. Impact of telelactation services on breastfeeding outcomes among Black and Latinx parents: protocol for the Tele-MILC randomized controlled trial. Trials. 2022 Jan 3;23(1):5. doi: 10.1186/s13063-021-05846-w.
PubMed 34980212
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Telelactation Services on Breastfeeding Outcomes: Digital Tele-MILC Trial
- ClinicalTrials.gov ID
- NCT04856163
- Acronym / sponsor ID
- R01NR018837
- Conditions
- Breastfeeding
- Keywords
- telehealth, telemedicine, health equity, disparities, breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,108 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Posted 3 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will assess the impact of a novel breastfeeding support intervention ("telelactation"), delivered via video calls on personal devices including mobile phones and tablets. The goal of this intervention is to increase access to International Board Certified Lactation Consultants to improve, and reduce disparities in, breastfeeding rates. By implementing a digital randomized controlled trial that recruits participants through a popular pregnancy tracker mobile phone application, this mixed methods study will recruit a national sample of 1800-2400 individuals (depending on rate of attrition) during their third trimester of pregnancy to 1) provide evidence on the effectiveness of a widely available, yet understudied, service and 2) leverage technology to promote one of the most widely recommended health behaviors to improve children's health and to reduce disparities in key maternal and child health outcomes.
Detailed description
This study is a pragmatic, parallel design randomized controlled trial that will generate evidence on the impact of telelactation on breastfeeding duration and exclusivity and explore differences in effectiveness by race/ethnicity. The study is mixed methods, and uses a sequential explanatory design in which qualitative interviews are used to explain and contextualize findings from the quantitative outcomes analysis. We will recruit primiparous, pregnant individuals age > 18 who intend to breastfeed and live in states most underserved by IBCLCs. Recruitment will occur via Ovia, a pregnancy tracker mobile phone application (app) used by one million pregnant individuals in the U.S. annually. Participants will be randomized to: 1) on-demand telelactation video calls on personal devices or 2) ebook on infant care/usual care. Breastfeeding outcomes will be captured via surveys and interviews and compared across racial and ethnic groups. This study will track participants for eight months (including six months postpartum), generating 1) quantitative data on the impact of telelactation and differences in effectiveness across racial and ethnic minority groups; and 2) rich qualitative data on the experiences of different subgroups of parents with the intervention, including barriers to use, satisfaction, and strengths and limitations of this delivery model.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telelactation support | Experimental | Behavioral: Telelactation supportParticipants in the experimental group will receive unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services will be available through mobile phone app. |
| ebook | No intervention | –Participants in the control arm will receive care as usual. They will also receive a ebook with content on infant care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- pregnant with first child
- intend to attempt breastfeeding
- residing in a state underserved by IBCLCs
Key exclusion criteria (4 listed)
- non-singleton pregnancy
- advised by healthcare provider not to breastfeed for a medical reason (e.g., HIV+ status, chemotherapy planned)
- in police custody or incarcerated
- infant to be separated from birthing parent (e.g., given up for adoption, military deployment)
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 |
|---|---|---|
| Telelactation supportParticipants will get unlimited access (through 24 weeks postpartum) to video calls with lactation consultants who are available 24/7. Participants can use the service as demanded. | Behavioural | Telelactation support |
Primary outcome
Breastfeeding Duration 1
Time frame: 6 months postpartum
Number of participants who report any breastfeeding at 6 months
Breastfeeding Duration 2
Time frame: 6 months post-partum
Time to cessation of breastfeeding in months (as measured by reported age of infant when completely stopped receiving breastmilk)
Breastfeeding Exclusivity
Time frame: 6 months postpartum
Number of participants who report no formula use at 6 months
1 secondary outcome
Breastfeeding Satisfaction
Time frame: 6 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40014345Uscher-Pines L, Kapinos K, Waymouth M, Howell K, Alvarado G, Ray K, Demirci J, Mehrotra A, Rogers R, James KF, DeYoreo M. Telelactation Services and Breastfeeding by Race and Ethnicity: A Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2461958. doi: 10.1001/jamanetworkopen.2024.61958.
- Derived from this study: PubMed 34980212Uscher-Pines L, Demirci J, Waymouth M, Lawrence R, Parks A, Mehrotra A, Ray K, DeYoreo M, Kapinos K. Impact of telelactation services on breastfeeding outcomes among Black and Latinx parents: protocol for the Tele-MILC randomized controlled trial. Trials. 2022 Jan 3;23(1):5. doi: 10.1186/s13063-021-05846-w.
- Individual participant dataSharing planned: Yes. Data resulting from the proposed research will be shared with external researchers who request access beginning one year after the project ends. Results will be available to other researchers, public health workers, healthcare professionals, and community leaders who are interested in exploring approaches to improving breastfeeding rates following a brief application process. Constraints imposed by human research subjects protection regulations (e.g., HIPAA Protected Health Information) and RAND's IRB will be recognized as allowed by NIH. External researchers interested in investigator data, survey instruments, and other research methodology and procedures will obtain this information through collaborative agreements (e.g., data use agreements) with the principal investigator and co-investigators, as required by NIH's data sharing policy.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telelactation support in people with Breastfeeding, run by RAND 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 4 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 3 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Duration 1 (time frame: 6 months 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?
On the ClinicalTrials.gov record for NCT04856163, which also lists 2 linked publications.
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 3 Jan 2025.