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

Breastfeeding Clinical Trial

Official title:

Strengthening Babies Through Mobile Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853850
• Other study ID #: 16-19171
• Status: Completed
• Phase: N/A
• Start date: September 28, 2017
• Est. completion date: November 10, 2019

Study information

• Verified date: March 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 582
• Est. completion date: November 10, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Breastfeeding, Exclusive

Intervention

Behavioral:
• Mobile phone text messages
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.

Locations

Country	Name	City	State
Honduras	Public Hospital Roatan	Coxen Hole	Roatan

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	Public Hospital Roatan, Honduras, University of California, San Francisco

Country where clinical trial is conducted

Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclusive breastfeeding rate at 2 months of age	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	Exclusive breastfeeding rate at 4 months of age	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
Secondary	Exclusive breastfeeding rate at 6 months of age	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
Secondary	Breastfeeding rate at 4 months of age	Proportion of infants with any amount of breastfeeding at 4 months of age	4 months after date of enrollment
Secondary	Breastfeeding rate at 6 months of age	Proportion of infants with any amount of breastfeeding at 6 months of age	6 months after date of enrollment
Secondary	Diarrheal disease at 2 months of age	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
Secondary	Diarrheal disease at 4 months of age	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
Secondary	Diarrheal disease at 6 months of age	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
Secondary	Infant feeding practice at 2 months of age	Other types of food given during 24 hours preceding data collection at 2 months of age	2 months after date of enrollment
Secondary	Infant feeding practice at 4 months of age	Other types of food given during 24 hours preceding data collection at 4 months of age	4 months after date of enrollment
Secondary	Infant feeding practice at 6 months of age	Other types of food given during 24 hours preceding data collection at 6 months of age	6 months after date of enrollment