Prenatal Interventions to Promote Exclusive Breastfeeding

NCT03107715 | Completed Results

• 1 other identifier: 04-17-04
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Exclusive breastfeeding through age 6 months is the optimal infant feeding method due to lifesaving benefits for children and mothers (AAP, others). Exclusive breastfeeding in-hospital is critical because in-hospital formula supplementation doubles risk of non-exclusive breastfeeding at 30-60 days (Chantry et al, 2014). While breastfeeding initiation rates have increased at our inner-city Baby Friendly - designated maternity hospital, exclusive breastfeeding lags. CDC mPINC data (maternity practices in infant nutrition and care, 2015) demonstrate this is a national problem, with \>50% of surveyed hospitals endorsing supplementation of "10-49%" of breastfed infants. Study Objective: The study objective is to evaluate acceptance/satisfaction of 2 prenatal interventions (breastfeeding champion and positive messaging) and to determine if these affect exclusive breastfeeding intention and practice. Methods: In this prospective intervention study with follow-up chart review, we will pilot two 5-minute-long iPad-based interventions for 1 month each in obstetrical clinics, following a required 28-week obstetrical visit breastfeeding education. All expectant mothers (including 14-17 year olds with guardian) are eligible. Outcomes are acceptance (enrollment rate), satisfaction (Likert-based), impact on exclusive breastfeeding intention (pre/post query) and secondarily impact on exclusive breastfeeding in-hospital and at 2 weeks.

Conditions

Breastfeeding; Intention; Health Behavior

Keywords

exclusive breastfeeding; health disparity; prenatal intervention

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Intended to Exclusively Breastfeed Post-intervention

  Single query "How do you plan to feed your baby?" with 4 possible responses Just formula / Both breastmilk and formula / Just breastmilk / Unsure

  15 minutes

• Number of Participants Who Reported Their Intervention as "Very Interesting" (Response=5) on a 5 Point Likert Scale

  Single 5 point Likert scale with query "Was the intervention you received interesting and enjoyable?" Analyzed as all those who said 5 "very interesting" on a 5 point Likert scale; higher score indicates the participant liked/was more interested in the intervention; minimum score =1, maximum score = 5; No scale title - Question was: Was the intervention you received interesting and enjoyable? Please give us your overall impression on a scale from 1-5!

  15 minutes

Secondary Outcomes (2)

• Number of Participants Who Exclusively Breastfed In-hospital

  2 days

• Number of Participants Who Exclusively Breastfed at 2 Weeks Postpartum

  2 weeks

Study Arms (2)

Breastfeeding Champion

ACTIVE COMPARATOR

The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.

Behavioral: Breastfeeding Champion

Positive Messaging

ACTIVE COMPARATOR

The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.

Behavioral: Positive Messaging

Interventions

Breastfeeding Champion BEHAVIORAL

iPad-based behavioral intervention facilitated by researcher

Breastfeeding Champion

Positive Messaging BEHAVIORAL

iPad based behavioral intervention facilitated by researcher

Positive Messaging

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: must be an expectant woman - self-representation of gender identity is required
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Expectant women receiving prenatal care at UH MacDonald Women's Health Clinic or MAC1200 CLinic
• Completed required breastfeeding education presented at or before 28 weeks of gestation
• Age 14 - 17 years must have guardian/parent present who consents to teen participation, and teen must then assent to participation
• Ages 18 years and older must consent to participate

You may not qualify if:

• Medical indication for use of formula only after delivery including HIV+ or will require chemotherapy treatment

Sponsors & Collaborators

• Lydia Furman: lead
• University Hospitals Cleveland Medical Center: collaborator
• Mt. Sinai Health Care Foundation: collaborator

Study Sites (1)

University Hospital MacDonald Women's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Breast Feeding; Health Behavior

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Limitations and Caveats

This was not a randomized controlled trial - there were no control subjects - this was an active comparator trial and participants were enrolled in non-random blocks.

Results Point of Contact

• Title: Lydia Furman MD, PI
• Organization: University Hospitals Rainbow Babies and Children's Hospital

lydia.furman@uhhospitals.org

216-844=8260

Study Officials

• Rebecca Farr, BSE

  CWRU SOM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Sequential presentation of 2 prototype interventions with pre/post test and follow up

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: May 8, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: June 23, 2020
• Results First Posted: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)