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Completed

NCT Number: NCT04258709

PRenatal Video-Based Education and PostPARtum Effects

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AME

Behavioral

Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.

Video-based infant care education

Behavioral

Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.

Primary outcomes

  1. Breastfeeding Exclusivity

    Time frame: 2 weeks postpartum

    Whether participant is feeding 100% breast milk at 2 weeks postpartum

  2. 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)

Secondary outcomes

  1. Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization

    Time frame: 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).

  2. Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum

    Time frame: 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).

  3. Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum

    Time frame: 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).

  4. Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum

    Time frame: 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).

  5. Number of Participants Exclusively Breastfeeding at 6 Months Postpartum

    Time frame: 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. 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)

  7. Breastfeeding Exclusivity (Categorical)

    Time frame: 2 weeks

    Categorical outcome indicating proportional range of breast milk feeds since infant was born

  8. Breastfeeding Exclusivity (Categorical)

    Time frame: 6 weeks postpartum

    Categorical outcome indicating proportional range of breast milk feeds in past week

  9. Breastfeeding Exclusivity (Categorical)

    Time frame: 12 weeks postpartum

    Categorical outcome indicating proportional range of breast milk feeds in past week

  10. Breastfeeding Exclusivity (Categorical)

    Time frame: 6 months postpartum

    Categorical outcome indicating proportional range of breast milk feeds in past week

  11. Breastfeeding Self-efficacy

    Time frame: 6 weeks postpartrum

    Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)

  12. Breastfeeding Self-efficacy

    Time frame: 12 weeks postpartum

    Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)

  13. Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum)

    Time frame: 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.

  14. Number of Participants Breastfeeding at 2 Weeks Postpartum

    Time frame: 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.

  15. Number of Participants Breastfeeding at 6 Weeks Postpartum

    Time frame: 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.

  16. Number of Participants Breastfeeding at 12 Weeks Postpartum

    Time frame: 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.

  17. Number of Participants Breastfeeding at 6 Months Postpartum

    Time frame: 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.

  18. Number of Participants Breastfeeding at 12 Months Postpartum

    Time frame: 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.

  19. Onset of Lactogenesis II

    Time frame: 2 weeks postpartum

    Recall of lactogenesis II in post-birth days

  20. Perceived Milk Supply (Continuous)

    Time frame: 2 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)

  21. Perceived Milk Supply (Continuous)

    Time frame: 6 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)

  22. Perceived Milk Supply (Continuous)

    Time frame: 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)

  23. Perceived Milk Supply (Dichotomous)

    Time frame: 2 weeks postpartum

    Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)

  24. Perceived Milk Supply (Dichotomous)

    Time frame: 6 weeks postpartum

    Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)

  25. Perceived Milk Supply (Dichotomous)

    Time frame: 12 weeks postpartum

    Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)

  26. Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: PREPARE

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Feb 6, 2020
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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