NCT04258709

PRenatal Video-Based Education and PostPARtum Effects

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breastfeeding

Interventions

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

Timeline

• Start date: 2020-09-23
• Primary completion: 2023-12-13
• Completion: 2024-11-29
• First posted: 2020-02-06
• Last updated: 2025-03-19
• Results posted: 2025-03-19

Locations

1 site across 1 country: United States