PRenatal Video-Based Education and PostPARtum Effects (PREPARE)
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|ClinicalTrials.gov Identifier: NCT04258709|
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : April 27, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding||Behavioral: AME Behavioral: Video-based infant care education||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
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.
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women|
|Actual Study Start Date :||August 31, 2020|
|Estimated Primary Completion Date :||January 1, 2024|
|Estimated Study Completion Date :||January 1, 2024|
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.
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.
- Breastfeeding exclusivity [ Time Frame: 2 weeks postpartum ]current provision of only breast milk feeds
- 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)
- 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
- Breastfeeding exclusivity (categorical) [ Time Frame: 2 weeks ]Categorical outcome indicating proportional range of breast milk feeds since infant was born
- 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)
- Breastfeeding exclusivity (categorical) [ Time Frame: 6 weeks, 12 weeks, 6 months postpartum ]Categorical outcome indicating proportional range of breast milk feeds in past week
- 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
- 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)
- Onset of lactogenesis II [ Time Frame: 2 weeks postpartum ]Recall of lactogenesis II in post-birth days
- 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)
- Perceived milk supply (dichotomous) [ Time Frame: 2, 6, and 12 weeks postpartum ]Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
- Experiences with and perceptions of AME [ Time Frame: 6 weeks postpartum ]Qualitative assessment via interviews with a subset of participants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258709
|Contact: Melissa Glasser, PhDfirstname.lastname@example.org|
|Contact: Jill Demirci, PhDemail@example.com|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Melissa Glasser, PhD 412-624-6997 firstname.lastname@example.org|
|Contact: Jill Demirci, PhD 412-648-9236 email@example.com|
|Principal Investigator: Jill Demirci, PhD|
|Principal Investigator:||Jill Demirci, PhD||University of Pittsburgh|