PRenatal Video-Based Education and PostPARtum Effects

Study Overview
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Brief Summary
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The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. AME involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among women with higher BMI, including impaired breastfeeding self-efficacy, insufficient milk supply (critical period endocrine modulation of milk volume), and early formula supplementation in the context of a medically complex birth (availability of banked antenatal milk). Participants will be enrolled in their third trimester of pregnancy and allocated into one of two study arms: 1) AME instruction delivered by remote, live International Board Certified Lactation Consultants via an innovative app-based telelactation platform; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). Video-based education for both groups will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing AME 1-2 times per day at home. Measured outcomes of interest will include short and long-term breastfeeding practices (e.g., breastfeeding duration, exclusivity) and participants' experiences with and perceptions of AME.

Detailed Description
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The purpose of the PREPARE Trial is to examine the impact of an antenatal milk expression (AME) intervention among women with pre-pregnancy BMI 25 or more on breastfeeding outcomes, including breastfeeding self-efficacy, breastfeeding duration and exclusivity, and perception of insufficient milk supply. Specifically, the investigators will: Determine the effect of the AME intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum. Explore the sustained effect of the AME intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum. Examine participants' experiences with and perceptions of AME.

Official Title
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Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women

Conditions
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Breastfeeding

Intervention / Treatment
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* Behavioral: AME
* Behavioral: Video-based infant care education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women who: have a pre-pregnancy BMI ≥ 25 are ≥ 18 years are English-speaking are 34 0/7-36 6/7 gestational weeks are nulliparous intend to/have interest in breastfeeding after birth are having a singleton pregnancy plan to receive prenatal care and deliver at select hospital/birth facility systems (access to EMR data) Exclusion Criteria: contraindications to breastfeeding as specified by the American Academy of Pediatrics history of breast reduction surgery or radiation indication for delivery by 37 weeks gestation gestational or pre-existing diabetes

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antenatal Milk Expression (AME) Intervention Group<br>Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk. | Behavioral: AME<br>* Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.<br>|
| Active Comparator: Video-based Infant Care Education Control Group<br>Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.). | Behavioral: Video-based infant care education<br>* Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding exclusivity | current provision of only breast milk feeds | 2 weeks postpartum | 
| Breastfeeding self-efficacy | Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome) | 2 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding exclusivity (dichotomous) | Dichotomous outcome of current provision of only breast milk feeds | Postpartum hospitalization (0-4 days postpartum), 2 weeks, 6 weeks, 12 weeks, 6 months postpartum | 
| Breastfeeding exclusivity (categorical) | Categorical outcome indicating proportional range of breast milk feeds since infant was born | 2 weeks | 
| Breastfeeding exclusivity (categorical) | Categorical outcome indicating proportional range of breast milk feeds during postpartum/birth hospitalization (0-4 days postpartum) | 0-4 days postpartum | 
| Breastfeeding exclusivity (categorical) | Categorical outcome indicating proportional range of breast milk feeds in past week | 6 weeks, 12 weeks, 6 months postpartum | 
| Breastfeeding duration | Current provision of any breast milk | Postpartum hospitalization (0-4 days postpartum), postpartum weeks 2, 6, 12; 6 and 12 months postpartum | 
| Breastfeeding self-efficacy | Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome) | Postpartum weeks 6 and 12 | 
| Onset of lactogenesis II | Recall of lactogenesis II in post-birth days | 2 weeks postpartum | 
| Perceived milk supply (continuous) | Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome) | 2, 6, and 12 weeks postpartum | 
| Perceived milk supply (dichotomous) | Endorsement of insufficient milk supply via investigator created item (dichotomous outcome) | 2, 6, and 12 weeks postpartum | 
| Experiences with and perceptions of AME | Qualitative assessment via interviews with a subset of participants | 6 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antenatal milk expression, antenatal colostrum