NCT02214849

Brief Summary

The purpose of this study is to find out if a two-way texting platform to be used as an adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among women enrolled in the WIC program in Connecticut. The hypothesis of the study is that providing additional information and support through text messaging starting in pregnancy and continuing after the birth of the child will increase exclusive breastfeeding rates during the first six months of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

August 1, 2014

Last Update Submit

April 28, 2017

Conditions

Breastfeeding Support

Keywords

BreastfeedingBreastfeeding peer counselingExclusive breastfeedingFormula supplementationMobile healthWIC program

Outcome Measures

Primary Outcomes (3)

  • Change in Exclusive Breastfeeding Rate

    2 weeks after birth

  • Change in Exclusive Breastfeeding Rate

    3 months after birth

  • Change in Exclusive Breastfeeding Rate

    6 months after birth

Secondary Outcomes (13)

  • Chance in the Percent of WIC Participants Reached by Breastfeedng Counselor

    48 hours after giving birth

  • Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors

    2 weeks after birth

  • Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors

    3 months after birth

  • Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors

    6 months after birth

  • Change in breastfeeding self-efficacy

    2 weeks after birth

  • +8 more secondary outcomes

Study Arms (1)

LATCH Intervention

EXPERIMENTAL

Women enrolled in the WIC program and receiving breastfeeding peer counseling services will receive text messages to support them with their breastfeeding intentions. They will start receiving automated text messages starting in pregnancy and continuing throughout the first 6 months after giving birth. Messaging during pregnancy will emphasize what to expect in the hospital, the onset of lactation, skin-to-skin contact with baby, early and often breastfeeding in post-partum period, milk transfer (suck \& swallow), positioning (with links), common breastfeeding problems and how to seek help. Throughout the study, participants will be able to respond to automated text messages with specific questions that will be received and answered by their WIC program peer counselors. Texting will also have prompts to respond occasionally (at minimum once every two weeks) to ensure that phone is still in service and that the participant in the intervention arm are receiving intervention.

Behavioral: LATCH Intervention

Interventions

LATCH InterventionBEHAVIORAL
LATCH Intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women \> 18 years
  • Prenatal intention to breastfeed
  • Prenatal enrollment \< 28 weeks gestation
  • Have an unlimited text message cell phone plan
  • Knows how to send a text message
  • th grade literacy level

You may not qualify if:

  • Lack of fluency in either English or Spanish
  • Infant born premature (\<37 weeks)
  • \> 3 days in NICU
  • Any major maternal-newborn medical problem affecting breastfeeding
  • Birth weight \<5lbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Public Health

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

    PMID: 32813276DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Rafael Perez-Escamilla, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Nurit Harari, MD

    Yale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 12, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 1, 2017

Record last verified: 2017-04

Locations

US(1)