LIFT: Telemedicine Breastfeeding Support

Study Overview
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Brief Summary
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The central hypothesis guiding this project is that tailored breastfeeding support, that leverages easily accessible telemedicine technologies, can improve breastfeeding outcomes among late preterm dyads. The long-term goals of this project are to improve maternal and child health and reduce health disparities by designing and implementing evidence-based interventions to improve breastfeeding outcomes for this challenging patient population. This study seeks to identify lactation support practices that improve breastfeeding duration and to test the effect of telemedicine breastfeeding support on breastfeeding duration, among the nearly one in ten mothers who deliver late preterm (34-37 6/7 weeks), as this subpopulation of mothers faces the highest rates of premature breastfeeding cessation

Official Title
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Telemedicine Breastfeeding Support Following Late Preterm Delivery: A Randomized Controlled Trial

Conditions
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Breastfeeding

Intervention / Treatment
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* Behavioral: Telemedicine Support
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: maternal age 18-49 years late preterm delivery (34-37 6/7 weeks) enrollment up to 1 week postpartum breastfeeding initiated access to a smartphone, tablet, or laptop computer in their home Exclusion Criteria: incarceration inability to communicate in English infant with medical condition compromising breastfeeding (e.g. cleft lip and/or palate).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine Support<br>Weekly telemedicine breastfeeding support visits for four weeks, delivered via telemedicine | Behavioral: Telemedicine Support<br>* Telemedicine intervention<br>|
| Placebo Comparator: Control<br>Standard of care | Other: Standard of Care<br>* Standard of Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience | Mean score on a modified, 16-item Interactive Telehealth Satisfaction Scale >48 (corresponding to better than neutral on a 5 point Likert scale, 16 questions). | One month post-enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to cessation | Time to breastfeeding cessation (assessed via monthly surveys as no to infant receiving any breast milk in last 24 hours) | Monthly up to 12 months | 
| Exclusive breastfeeding cessation | Time to exclusive breastfeeding cessation (assessed via monthly surveys, defined by initiation of formula, water, juice, other liquids, or solid foods) | Monthly up to 12 months | 
| Breastfeeding at 3 months | Proportion of infants breastfeeding at 3 months (assessed via 24 hour recall from infant's mother) | 3 months | 
| Exclusive breastfeeding | Proportion of infants breastfeeding without supplementation with other food or liquids at 3 months (assessed via 24 hour recall from infant's mother) | 3 months | 
| Individual satisfaction questions | Mean satisfaction on each Interactive Telehealth Satisfaction Scale question | 1 month post enrollment |