PRenatal Video-Based Education and PostPARtum Effects (PREPARE)

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

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding
• Intervention / Treatment: Behavioral: AME; Behavioral: Video-based infant care education

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

1. contraindications to breastfeeding as specified by the American Academy of Pediatrics
2. history of breast reduction surgery or radiation
3. indication for delivery by 37 weeks gestation
4. gestational or pre-existing diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antenatal Milk Expression (AME) Intervention Group; 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; Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
Active Comparator: Video-based Infant Care Education Control Group; 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; Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding Exclusivity	Whether participant is feeding 100% breast milk at 2 weeks postpartum	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
Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization	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).	Postpartum hospitalization (0-4 days postpartum)
Number of Participants Exclusively Breastfeeding at 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).	2 weeks postpartum
Number of Participants Exclusively Breastfeeding at 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).	6 weeks postpartum
Number of Participants Exclusively Breastfeeding at 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).	12 weeks postpartum
Number of Participants Exclusively Breastfeeding at 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).	6 months postpartum
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 since infant was born	2 weeks
Breastfeeding Exclusivity (Categorical)	Categorical outcome indicating proportional range of breast milk feeds in past week	6 weeks postpartum
Breastfeeding Exclusivity (Categorical)	Categorical outcome indicating proportional range of breast milk feeds in past week	12 weeks postpartum
Breastfeeding Exclusivity (Categorical)	Categorical outcome indicating proportional range of breast milk feeds in past week	6 months postpartum
Breastfeeding Self-efficacy	Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)	6 weeks postpartrum
Breastfeeding Self-efficacy	Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)	12 weeks postpartum
Number of Participants Breastfeeding at 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.	Postpartum hospitalization (0-4 days postpartum)
Number of Participants Breastfeeding at 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.	2 weeks postpartum
Number of Participants Breastfeeding at 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.	6 weeks postpartum
Number of Participants Breastfeeding at 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.	12 weeks postpartum
Number of Participants Breastfeeding at 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.	6 months postpartum
Number of Participants Breastfeeding at 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.	12 months postpartum
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 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)	6 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)	12 weeks postpartum
Perceived Milk Supply (Dichotomous)	Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)	2 weeks postpartum
Perceived Milk Supply (Dichotomous)	Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)	6 weeks postpartum
Perceived Milk Supply (Dichotomous)	Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)	12 weeks postpartum
Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period	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	6 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Jill Demirci, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): December 13, 2023
• Study Completion (Actual): November 29, 2024

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: antenatal milk expression; antenatal colostrum
• Other Study ID Numbers: STUDY19030116; R01HD098186 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw (subject level) and/or aggregate data will be shared with other investigators as requested after: 1) publication of main findings; 2) removal of identifiers that would permit linkages to individual research participants; and 3) removal of variables that could lead to deductive disclosure of the identity of individuals. Any individual requests for data sharing will be executed in collaboration with the University of Pittsburgh Institutional Review Board to ensure strict adherence to policies for protections of human subjects. In addition, at the conclusion of the study, de-identified data will be submitted to the National Institute of Child Health and Development (NICHD) Data Repository to ensure public availability.
• IPD Sharing Time Frame: At the conclusion of the study, after publication of main findings.
• IPD Sharing Access Criteria: Contact study investigator or NICHD for access to data repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No