Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| ebook | No Intervention | Participants in the control arm will receive care as usual. They will also receive a ebook with content on infant care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telelactation support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding Duration 1 | Number of participants who report any breastfeeding at 6 months | 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) | 6 months post-partum |
| Breastfeeding Exclusivity | Number of participants who report no formula use at 6 months | 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months postpartum |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAND Corporation | Arlington | Virginia | 22202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40014345 | Derived | 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. | |
| 34980212 | Derived | Uscher-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. |
Not provided
Not provided
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.
2025-2028
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telelactation Support | Participants in the experimental group received unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services were available through mobile phone app. |
| FG001 | Ebook | Participants in the control arm received care as usual. They will received a ebook with content on infant care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telelactation Support | Participants in the experimental group received unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services were available through mobile phone app. |
| BG001 | Ebook |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Breastfeeding Duration 1 | Number of participants who report any breastfeeding at 6 months | Posted | Count of Participants | Participants | 6 months postpartum |
|
9 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telelactation Support | Participants in the experimental group received unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services were available through mobile phone app. |
Not provided
Not provided
Generalizability: Digital trials may not reach individuals without reliable access to technology and digital literacy; Inclusion criteria: We were not able to assess the impact of telelactation on breastfeeding initiation because we only enrolled individuals who intended to breastfeed; Outcomes were self-reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lori Uscher-Pines | RAND | 703-413-1100 | luscherp@rand.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2022 | Dec 11, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants in the control arm received care as usual. They also received an ebook with content on infant care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Health insurance | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Breastfeeding Duration 2 | Time to cessation of breastfeeding in months (as measured by reported age of infant when completely stopped receiving breastmilk) | Posted | Mean | Standard Deviation | months | 6 months post-partum |
|
|
|
|
| Primary | Breastfeeding Exclusivity | Number of participants who report no formula use at 6 months | Posted | Count of Participants | Participants | 6 months postpartum |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months postpartum |
|
|
|
|
| 0 |
| 1,052 |
| 0 |
| 1,052 |
| 0 |
| 1,052 |
| EG001 | Ebook | Participants in the control arm received care as usual. They also received a ebook with content on infant care. | 0 | 1,056 | 0 | 1,056 | 0 | 1,056 |
Not provided
Not provided
Not provided