The Impact of Telelactation Services on Breastfeeding Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Telelactation Services on Breastfeeding Outcomes: Digital Tele-MILC Trial

Conditions
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Breastfeeding

Intervention / Treatment
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* Behavioral: Telelactation support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age pregnant with first child intend to attempt breastfeeding residing in a state underserved by IBCLCs Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telelactation support<br>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. | Behavioral: Telelactation support<br>* 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.<br>|
| No Intervention: ebook<br>Participants in the control arm will receive care as usual. They will also receive a ebook with content on infant care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding duration 1 | Any breastfeeding (yes/no) 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 | No formula use in the prior 24 hours (yes/no) at 6 months | 6 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding satisfaction | Breastfeeding satisfaction (self-reported via questionnaire at 6 months postpartum). Score on five-item maternal/infant breastfeeding satisfaction scale (which is a subscale of the H&H lactation scale). | 6 months postpartum | 
| Experiences with telelactation | Qualitative data from semi-structured interviews on experiences with telelactation | 8 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telehealth, telemedicine, health equity, disparities, breastfeeding