- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03853850
Using Mobile Phone Text Messaging System to Improve Exclusive Breastfeeding Rate in a Resource-poor Caribbean Island
Strengthening Babies Through Mobile Health
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Roatan
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Coxen Hole, Roatan, Honduras
- Public Hospital Roatan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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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
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa Rasmussen, MD, University of California, Davis
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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