PRenatal Video-Based Education and PostPARtum Effects (PREPARE)

April 8, 2024 updated by: Jill R. Demirci, PhD, RN, IBCLC, University of Pittsburgh

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

Active, not recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Melissa Glasser, PhD
  • Phone Number: 412-624-6997
  • Email: mlg130@pitt.edu

Study Contact Backup

  • Name: Jill Demirci, PhD
  • Phone Number: 412-648-9236
  • Email: jvr5@pitt.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 weeks postpartum
current provision of only breast milk feeds
2 weeks postpartum
Breastfeeding self-efficacy
Time Frame: 2 weeks postpartum
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)
Time Frame: Postpartum hospitalization (0-4 days postpartum), 2 weeks, 6 weeks, 12 weeks, 6 months postpartum
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)
Time Frame: 2 weeks
Categorical outcome indicating proportional range of breast milk feeds since infant was born
2 weeks
Breastfeeding exclusivity (categorical)
Time Frame: 0-4 days postpartum
Categorical outcome indicating proportional range of breast milk feeds during postpartum/birth hospitalization (0-4 days postpartum)
0-4 days postpartum
Breastfeeding exclusivity (categorical)
Time Frame: 6 weeks, 12 weeks, 6 months postpartum
Categorical outcome indicating proportional range of breast milk feeds in past week
6 weeks, 12 weeks, 6 months postpartum
Breastfeeding duration
Time Frame: Postpartum hospitalization (0-4 days postpartum), postpartum weeks 2, 6, 12; 6 and 12 months postpartum
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
Time Frame: Postpartum weeks 6 and 12
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
Time Frame: 2 weeks postpartum
Recall of lactogenesis II in post-birth days
2 weeks postpartum
Perceived milk supply (continuous)
Time Frame: 2, 6, and 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)
2, 6, and 12 weeks postpartum
Perceived milk supply (dichotomous)
Time Frame: 2, 6, and 12 weeks postpartum
Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
2, 6, and 12 weeks postpartum
Experiences with and perceptions of AME
Time Frame: 6 weeks postpartum
Qualitative assessment via interviews with a subset of participants
6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2020

Primary Completion (Actual)

December 13, 2023

Study Completion (Estimated)

March 1, 2025

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)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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