PRenatal Video-Based Education and PostPARtum Effects

Not Applicable

Completed

Conditions: Breastfeeding

Interventions: Behavioral: AME
Behavioral: Video-based infant care education

Registration Number: NCT04258709

Lead Sponsor: University of Pittsburgh

Brief Summary: 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: 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:

1. Determine the effect of the AME intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum.

2. Explore the sustained effect of the AME intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum.

3. Examine participants' experiences with and perceptions of AME.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 280

Inclusion Criteria

Pregnant women who:
1. have a pre-pregnancy BMI ≥ 25
2. are ≥ 18 years
3. are English-speaking
4. are 34 0/7-36 6/7 gestational weeks
5. are nulliparous
6. intend to/have interest in breastfeeding after birth
7. are having a singleton pregnancy
8. 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antenatal Milk Expression (AME) Intervention Group	AME	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.
Video-based Infant Care Education Control Group	Video-based infant care education	Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).

Primary Outcome Measures

Name	Time	Method
Breastfeeding Exclusivity	2 weeks postpartum	Whether participant is feeding 100% breast milk at 2 weeks postpartum
Breastfeeding Self-efficacy	2 weeks postpartum	Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum	6 weeks postpartum	This variable derived from participant self-report survey emailed at 6 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum	12 weeks postpartum	This variable derived from participant self-report survey emailed at 12 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization	Postpartum hospitalization (0-4 days postpartum)	This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum	2 weeks postpartum	This variable derived from participant self-report survey emailed at 2 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Number of Participants Exclusively Breastfeeding at 6 Months Postpartum	6 months postpartum	This variable derived from participant self-report survey emailed at 6 months postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Breastfeeding Exclusivity (Categorical)	6 months postpartum	Categorical outcome indicating proportional range of breast milk feeds in past week
Breastfeeding Self-efficacy	12 weeks postpartum	Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)
Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum)	Postpartum hospitalization (0-4 days postpartum)	This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Number of Participants Breastfeeding at 2 Weeks Postpartum	2 weeks postpartum	Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Number of Participants Breastfeeding at 6 Weeks Postpartum	6 weeks postpartum	Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Number of Participants Breastfeeding at 12 Weeks Postpartum	12 weeks postpartum	Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Number of Participants Breastfeeding at 6 Months Postpartum	6 months postpartum	Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Number of Participants Breastfeeding at 12 Months Postpartum	12 months postpartum	Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Onset of Lactogenesis II	2 weeks postpartum	Recall of lactogenesis II in post-birth days
Perceived Milk Supply (Continuous)	12 weeks postpartum	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)
Perceived Milk Supply (Dichotomous)	12 weeks postpartum	Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period	6 weeks postpartum	A subset of participants took place in a qualitative assessment via semi-structured interview. Numbers below represent the number of participants who endorsed each of the following categories during their interview: 1) discussing the impact of the study on their pregnancy/postpartum experience, 2) integration of AME into their daily life, and 3) utilization of antenatal milk during the postpartum period