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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03853850
Other study ID # 16-19171
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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