Prenatal Interventions to Promote Exclusive Breastfeeding

NCT ID: NCT03107715

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2018-08-31

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.

Detailed Description

Relevance:

This research is aligned with efforts to decrease infant mortality and associated racial disparities via culturally competent interventions, and our aim is that it will be possible to model a larger intervention trial using the data generated in this pilot study. The project showcases work which is clinically meaningful, addresses an important racial health disparity in a vulnerable population (predominantly African-American expectant women) and is allied with hospital quality measures (PC-05, exclusive breastfeeding in hospital).

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 and Aims:

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.

Study Aims are "1." To determine if intention to exclusively breastfeed changes from before to after the intervention is implemented "2." To determine the acceptance and satisfaction of the interventions "3." To determine and compare the rates of exclusive breastfeeding in-hospital and at 2-weeks postpartum among women who received the champion and positive messaging interventions

Methods:

Study Design: The study is a pretest-posttest sequential group design chosen to evaluate the effect of two prenatal breastfeeding interventions on exclusive breastfeeding intention. Intervention A (Breastfeeding Champion) and Intervention B (Positive Messaging) will be administered during months 1 and 2, respectively, of the study.

Population and Setting: The setting is University Hospitals MacDonald Women's Hospital, an academic tertiary care birthing center in urban Cleveland, OH with approximately 3,800 deliveries per year. The eligible population includes expectant women ages 14 years and up (with guardian present if ages 14-17 years) who are attending a prenatal visit at an on-site clinic and have completed required breastfeeding education presented at or before 28 weeks of gestation. The clinics serve a predominantly African-American WIC-eligible population.

Interventions: Both interventions use a secured and protected iPad, and the total interaction with the participant will take about 10 minutes. 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. 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.

Data Collection: After informed consent is obtained, sociodemographic information and a pretest to include feeding intention will be administered. Then following the 5-8 minute iPad-based intervention, a short posttest will be administered, which asks a Likert based question about intervention satisfaction and about feeding intention post-intervention. Postpartum, actual feeding method in hospital and at 2 weeks will be gathered by chart review. REDCap will be utilized for data entry.

Outcome Measures: These will reflect the aims:

"1." Intention to exclusively breastfeed post-intervention "2." Likert-based satisfaction with intervention received "3." Rates of exclusive breastfeeding in-hospital and at 2 weeks post-partum

Data Collection Tools: These were created by the study team.

Data analysis and Sample Size considerations:

Sample size - Aim #1 of the study is to determine if intention to exclusively breastfeed changes from before to after the interventions are implemented. There are no published data on this question utilizing these interventions with which to formulate a hypothesis and perform the requisite sample size to test that hypothesis. This will be considered a hypothesis generating study and feasibility of enrollment will determine the sample size. We will approach all eligible women during 2-month study period. We anticipate that approximately 31 women per week will be eligible, of whom approximately 80% will agree to participate, and over a 2-month study period, 250 women could be enrolled.

Data analysis - Nominal variables will be described using frequencies and percentages. Normally distributed continuous variables will be described using means and standard deviations, and non-normally distributed continuous variables will be described using medians and IQRs (interquartile ranges). We will compare nominal variables, e.g. those who received differing interventions (champion versus positive messaging) using Chi squared analyses or Fisher's exact test as appropriate. Distributionally appropriate two-sample tests will be used to compare continuous variables. Additional analyses may be carried out as the data indicate, and will be considered exploratory.

Conditions

Breastfeeding; Intention; Health Behavior

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Breastfeeding Champion

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.

Group Type: ACTIVE_COMPARATOR

Breastfeeding Champion

Intervention Type: BEHAVIORAL

iPad-based behavioral intervention facilitated by researcher

Positive Messaging

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.

Group Type: ACTIVE_COMPARATOR

Positive Messaging

Intervention Type: BEHAVIORAL

iPad based behavioral intervention facilitated by researcher

Interventions

Breastfeeding Champion

iPad-based behavioral intervention facilitated by researcher

Intervention Type: BEHAVIORAL

Positive Messaging

iPad based behavioral intervention facilitated by researcher

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: collaborator

Mt. Sinai Health Care Foundation

OTHER

Sponsor Role: collaborator

Lydia Furman

OTHER

Sponsor Role: lead

Responsible Party

Lydia Furman

Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rebecca Farr, BSE

Role: PRINCIPAL_INVESTIGATOR

CWRU SOM

Locations

University Hospital MacDonald Women's Hospital

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

04-17-04

Identifier Type: -

Identifier Source: org_study_id