PRenatal Video-Based Education and PostPARtum Effects (PREPARE)

University of Pittsburgh

Status: Completed

Conditions: Breastfeeding

Treatments: Behavioral: Video-based infant care education; Behavioral: AME

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04258709

STUDY19030116

R01HD098186 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 2 patient groups

Antenatal Milk Expression (AME) Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: AME

Video-based Infant Care Education Control Group

Active Comparator group

Description:

Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).

Treatment:

Behavioral: Video-based infant care education