Using Mobile Phone Text Messaging System to Improve Exclusive Breastfeeding Rate in a Resource-poor Caribbean Island

March 2, 2020 updated by: University of California, Davis

Strengthening Babies Through Mobile Health

This study will evaluate whether sending educational and supportive mobile phone text messages to mothers of infants, from babies' day of birth until 6 months of age, increases the rate of exclusive breastfeeding in Roatan, Honduras.

Study Overview

Status

Completed

Detailed Description

Encouraging and educational text messages and animations were created based on barriers to breastfeeding found during preceding focus groups and a baseline survey. Messages were written in English and translated into Spanish, with back-translation to ensure accuracy. Mothers who plan to or are already breastfeeding will be recruited and invited to participate in the study in the post-partum ward after delivery at Public Hospital Roatán. Written informed consent will be obtained. Three animated videos will be shown to mothers at enrollment providing information regarding breastfeeding technique, breastfeeding encouragement and general breastfeeding information. SMS messages will start at time of enrollment and continue through six months after enrollment. Messages will be delivered through Telerivet, an SMS interactive platform designed to send the educational and motivational messages to mothers' cell phones.

The intervention group will be polled when infants turn two months, four months, and six months regarding their infant feeding practices through Telerivet via SMS messaging. The primary outcome of this study is exclusive breastfeeding at 2 months of age, as compared to the exclusive breastfeeding rate obtained in our baseline cross sectional survey. Exclusive breastfeeding will be defined as giving only mother's breastmilk in the 24 hours preceding the interview. Mothers will also be asked if they are breastfeeding at all, age of infant when they last gave breast milk, the incidence of diarrheal illness in the past two weeks, and any other foods / liquids given to infant.

Study Type

Interventional

Enrollment (Actual)

582

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Roatan
      • Coxen Hole, Roatan, Honduras
        • Public Hospital Roatan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Recently delivered full term infants (>37 weeks gestation, less than 72 hours old)
  • 18 years of age or older, or emancipated minor, or if parent able to consent if <18 years of age
  • Intent to breastfeed
  • Own a phone that can receive SMS messages
  • Able to send SMS reply messages

Exclusion Criteria:

  • Mothers who report they can not read in Spanish nor English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Participating mothers will receive mobile phone text messages during their babies' first 6 months of life. Messages will educate mothers on breastfeeding and proper infant feeding.
From their babies' day of birth until 6 months of age, participating mothers will receive supportive and educational text messages to promote breastfeeding. Messages will be on benefits of breastfeeding, newborn hunger cues, proper latch technique, healthy infant feeding practice, and maternal self care. Messages will be sent regularly, initially several messages every day during the babies' first few weeks of life, then few messages every week. A total of 158 (***) messages will be sent. Messages will be sent in English or in Spanish depending on participant language preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive breastfeeding rate at 2 months of age
Time Frame: 2 months after date of enrollment
Proportion of infants exclusive breastfeeding at 2 months of age. Exclusive breastfeeding defined as only breastmilk in the 24 hours preceding data collection
2 months after date of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive breastfeeding rate at 4 months of age
Time Frame: 4 months after date of enrollment
Proportion of infants exclusively breastfeeding at 4 months of age. Exclusive breastfeeding defined as only breastmilk in the 24 hours preceding data collection
4 months after date of enrollment
Exclusive breastfeeding rate at 6 months of age
Time Frame: 6 months after date of enrollment
Proportion of infants exclusively breastfeeding at 6 months of age. Exclusive breastfeeding defined as only breastmilk in the 24 hours preceding data collection
6 months after date of enrollment
Breastfeeding rate at 4 months of age
Time Frame: 4 months after date of enrollment
Proportion of infants with any amount of breastfeeding at 4 months of age
4 months after date of enrollment
Breastfeeding rate at 6 months of age
Time Frame: 6 months after date of enrollment
Proportion of infants with any amount of breastfeeding at 6 months of age
6 months after date of enrollment
Diarrheal disease at 2 months of age
Time Frame: 2 months after date of enrollment
Diarrheal disease incidence at 2 months of age. Diarrheal disease defined as watery stool during 2 weeks preceding data collection
2 months after date of enrollment
Diarrheal disease at 4 months of age
Time Frame: 4 months after date of enrollment
Diarrheal disease incidence at 4 months of age. Diarrheal disease defined as watery stool during 2 weeks preceding data collection
4 months after date of enrollment
Diarrheal disease at 6 months of age
Time Frame: 6 months after date of enrollment
Diarrheal disease incidence at 6 months of age. Diarrheal disease defined as watery stool during 2 weeks preceding data collection
6 months after date of enrollment
Infant feeding practice at 2 months of age
Time Frame: 2 months after date of enrollment
Other types of food given during 24 hours preceding data collection at 2 months of age
2 months after date of enrollment
Infant feeding practice at 4 months of age
Time Frame: 4 months after date of enrollment
Other types of food given during 24 hours preceding data collection at 4 months of age
4 months after date of enrollment
Infant feeding practice at 6 months of age
Time Frame: 6 months after date of enrollment
Other types of food given during 24 hours preceding data collection at 6 months of age
6 months after date of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lisa Rasmussen, MD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 28, 2017

Primary Completion (ACTUAL)

July 3, 2019

Study Completion (ACTUAL)

November 10, 2019

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

February 22, 2019

First Posted (ACTUAL)

February 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 16-19171

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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