Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Breastfeeding Exclusivity
Study Overview
Brief 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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Statistician completing final analysis of data will be blinded to group assignment. An unbiased, third party will conduct qualitative interviews.
Participants, obstetric providers in recruitment clinics, and lactation consultant interventionists will be blinded to outcomes of interest.
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: AME (Behavioral)
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.).
Intervention: Video-based infant care education (Behavioral)
Outcomes
Primary Outcomes
Breastfeeding Exclusivity
Time Frame: 2 weeks postpartum
Whether participant is feeding 100% breast milk at 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)
Secondary Outcomes
- Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum(2 weeks postpartum)
- Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum(6 weeks postpartum)
- Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum(12 weeks postpartum)
- Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization(Postpartum hospitalization (0-4 days postpartum))
- Number of Participants Exclusively Breastfeeding at 6 Months Postpartum(6 months postpartum)
- Breastfeeding Exclusivity (Categorical)(6 months postpartum)
- Breastfeeding Self-efficacy(12 weeks postpartum)
- Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum)(Postpartum hospitalization (0-4 days postpartum))
- Number of Participants Breastfeeding at 2 Weeks Postpartum(2 weeks postpartum)
- Number of Participants Breastfeeding at 6 Weeks Postpartum(6 weeks postpartum)
- Number of Participants Breastfeeding at 12 Weeks Postpartum(12 weeks postpartum)
- Number of Participants Breastfeeding at 6 Months Postpartum(6 months postpartum)
- Number of Participants Breastfeeding at 12 Months Postpartum(12 months postpartum)
- Onset of Lactogenesis II(2 weeks postpartum)
- Perceived Milk Supply (Continuous)(12 weeks postpartum)
- Perceived Milk Supply (Dichotomous)(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(6 weeks postpartum)
- Breastfeeding Exclusivity (Categorical)(0-4 days postpartum)
- Breastfeeding Exclusivity (Categorical)(2 weeks)
- Breastfeeding Exclusivity (Categorical)(6 weeks postpartum)
- Breastfeeding Exclusivity (Categorical)(12 weeks postpartum)
- Breastfeeding Self-efficacy(6 weeks postpartrum)
- Perceived Milk Supply (Continuous)(2 weeks postpartum)
- Perceived Milk Supply (Continuous)(6 weeks postpartum)
- Perceived Milk Supply (Dichotomous)(2 weeks postpartum)
- Perceived Milk Supply (Dichotomous)(6 weeks postpartum)
Investigators
Jill R. Demirci, PhD, RN, IBCLC
Assistant Professor
University of Pittsburgh