Strengthening Babies Through Mobile Health
Phase: NA
Conditions: Breastfeeding, Breastfeeding, Exclusive
Sponsor: University of California, Davis

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INSTRUCTIONS: use in conjunction with the onlineInitial Review Application form when no 
sponsor authored protocol is available. 
1) 
Protocol Title 
Title: Strengthening Babies Through Mobile Health 
Protocol Version Date: 1/7/2019 
2) 
Objectives 
Cross-sectional survey: prevalence of exlusive breastfeeding within the last 24 hours for 2, 4 and 6 
month infants.  
Intervention: 
Primary Outcome: Proportion of exclusive breastfeeding within the last 24 hours in Roatan, 
Honduras for 2month old children. 
Secondary Outcomes:  
-Diarrheal disease incidence at age 2 months, 4 months and 6 months in Roatan, Honduras 
- Proportion of infants exclusively breast feeding at 4 and 6 months of life 
-Proportion of infants with any breastfeeding at 2, 4 and 6 months of life 
-Other types of food being given, if any 
 
Hypothesis to be tested:  
Intervention: Breastfeeding support and education through SMS technology will increase the 
proportion of exclusive breastfeeding infants in Roatan, Honduras at two months of life. 
3) 
Background 
Exclusive breastfeeding (EBF) for at least six months provides significant benefits to both 
infants and their mothers. Research shows that EBF decreases the incidence of pediatric 
infections, including: otitis media, gastroenteritis, necrotizing enterocolitis, meningitis, and 
pneumonia.1 Additionally, EBF for six months is associated with lower rates of hospitalization for 
lower respiratory infections, lower incidence of sudden infant death syndrome and obesity. It has 
also been associated with higher neurodevelopment outcomes. In developing countries, EBF 
decreases infant exposure to contaminated water sources. The diarrheal prevalence within two 
weeks in infants less than six months in Honduras was estimated to be 12.4% in 2011 according 
to the DHS. Breastfeeding also confers a financial benefit as parents are not required to 
purchase replacement feeding (e.g. infant formula). Promotion of breastfeeding in developing 
countries has been found to be the single most effective method to improve survival of infants 
and young children.  
Roatan is an island in the Caribbean Sea off the north coast of Honduras and has a population 
of 50,000. Estimated infant mortality in the island is 79 per 1,000 live births according to the 
most recent Honduran national data from 2012. This is compared to the national rate of 17 per 
1,000 live births and global rate of 32 per 1,000 in 2015. In addition, leading causes of infant 
mortality in Honduras in infants 1-11 months of age are respiratory infection (23.7%), diarrhea 
(33.8%), and other infections (9.6%). A local partnering physician observes an estimated 
exclusive breastfeeding rate of 30% in Roatan. According to the DHS in 2011-2012, in the 

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country of Honduras, it is estimated that 63.8% of mothers have early initiation of breastfeeding; 
however, the proportion of mothers exclusively breastfeeding under 6 months is only 31. In the 
bay islands, 53% of mothers initiate breastfeeding in the first hour and 73% initiate in the first 
day (DHS). Per the DHS, data regarding duration of breast feeding does not exist for the bay 
islands. Comparatively, the rate of exclusive breastfeeding in infants less than six months in 
developing countries in 2011 was approximately 39% according to UNICEF.  
There are limited studies focusing on exclusive breastfeeding in Roatan, Honduras. 
Interventions trialed in other contexts with low exclusive breastfeeding rates may be a benefit in 
this setting. Anecdotally, barriers to breastfeeding in this area include lack of education on 
benefits of breastfeeding, technical difficulty, and cosmetic reasons among others which has 
been identified from the local population. More qualitative research is needed to better 
understand the barriers and obstacles to breastfeeding, a research question our team is 
pursuing in a sister project.  
A systematic, community-based support system is needed to reach all new mothers to educate 
them on benefits as well as practical tips on breastfeeding. A study completed in Shanghai, 
China found that SMS education was effective in increasing duration of exclusive breastfeeding 
and delaying introduction of solid foods. Smart phones are used by an overwhelming majority of 
the island population, so we plan to explore SMS technology as a tool to achieve this. Our aim is 
to increase exclusive breastfeeding using SMS technology to reach a broad audience of new 
mothers with educational and motivational messages regarding breastfeeding and 
troubleshooting common challenges. This protocol describes a proposed study to evaluate the 
effectiveness of SMS text messaging in increasing the rate of exclusive breastfeeding in Roatan, 
Honduras. 
Inclusion and Exclusion Criteria 
 
Intervention Group 
We will enroll mothers who recently delivered full term infants (>37 weeks) at Public Hospital Roatán 
who intend to breastfeed.  Inclusion criteria are: 
1. Recently delivered full term infants (>37 weeks gestation, less than 72 hours old)  
2. 18 years of age or older, or emancipated minor, or if parent able to consent if <18 years of age  
3. Intent to breast feed  
4. Own a phone that can receive SMS messages 
5. Be literate (self-report of ability to read English or Spanish) 
6. Able to send SMS reply messages  
 
This study will NOT include adults unable to consent, pregnant women or prisoners.  
4) 
Study Timelines 
• The duration of an individual subject’s participation in the study: Approximately 6 months 
after enrollment  
• The duration anticipated to enroll all study subjects: Two years 
• The estimated date for the investigators to complete this study (complete primary analyses): 
September 2020 

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5) 
Study Endpoints 
 
Intervention: 
Primary Outcome: Proportion of exclusive breastfeeding within the last 24 hours in Roatan, 
Honduras for 2 month old children. 
Secondary Outcomes:  
-Diarrheal disease incidence within the last 2 weeks at age 2 months, 4 months and 6 months 
in Roatan, Honduras 
-Proportion of infants exclusively breast feeding at 4 and 6 months of life 
-Proportion of infants with any breastfeeding at 2, 4 and 6 months of life 
-Other types of food being given, if any 
6) 
Procedures Involved 
1.Pre-Intervention Convenience Sample: To determine the current prevalence of 
exclusive breastfeeding in Roatán, Honduras we will perform a pre-interventional cross-
sectional prevalence study to determine the baseline exclusive and any breastfeeding 
prevalence in Roatán within two weeks of two, four and six months of life. Mothers of 
infants that match this criteria who indicate they had an intention to breastfeed will be 
recruited in various pediatric clinic waiting rooms including public clinics in Flower’s Bay, 
Coxen Hole, French Harbor, Oak Park as well as 2 clinics directly associated with the 
Public Hospital Roatan, Roatán Volunteer Pediatric Clinic and Clinica Esperanza. Once 
verbal consent is obtained, we will conduct verbal interviews in English or Spanish based 
on participant preference. The verbal interview will include questions regarding current 
infant feeding practices, infant age, types of foods that have been introduced and 
incidence of diarrheal illnesses in the last two weeks. This data will be compiled into a 
database with a unique study ID and no patient identifiers.  
Data collection: A pre-intervention cross-sectional study will be conducted to determine 
baseline exclusive breastfeeding prevalence. Verbal consent will be obtained prior to 
surveying participants. Data will be collected with a verbal interview in English or Spanish 
per participant preference. This data will be transcribed to an excel spreadsheet. No 
patient identifiers will be collected and only a unique study ID will be linked to the data. 
This de-identified data set will be password protected.  
This portion of the study is now complete.  
2. Intervention: We will create targeted messages with animations to help mothers with 
breastfeeding. According to one of the pediatricians in Roatán, some of the barriers to 
breastfeeding include lack of education, cosmetic concerns and difficulty with technique. 
Therefore, the messages will provide education and advice regarding breastfeeding 
technique and encouragement to mothers. Messages will be written in both English and 
Spanish, and each participant will be asked to choose their preferred language at time of 
enrollment. Mothers who are interested in 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. Once a mother is enrolled into the study, a 
sample text survey in the language of preference will be sent to ensure text messages will 
be received. A secondary contact method (i.e. phone number, email) will also be 
requested if available, in case current phone number changes or is disconnected. 
Mothers will be given 20 Lemipras worth of cellular phone plan credit at time of enrollment 
as compensation for costs associated with responding to SMS messages. In addition, 

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mothers will be shown a sample completed survey in order to understand how to properly 
answer questions via the SMS survey system. Mothers will be asked to complete test 
survey in order to practice how to answer it properly. If mothers do not have their phone 
with them at enrollment, it will be verbally agreed that mothers will complete the test 
survey when possible. Mothers will be awarded 70 Lempiras worth of cellular phone plan 
credit after completing the survey of 2 months as compensation for completing surveys at 
2, 4 and 6 months.Three animated videos will be shown to mothers at enrollment 
providing information regarding breastfeeding technique, breastfeeding encouragement 
and general breastfeeding information. Mothers can decline viewing these animations, but 
will still be eligible to participate in this study. 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. We will send text messages, limited to 
160 characters. The content will include recognizing newborn hunger cues, latch 
methods, messages of encouragement, frequency  of feeding and maternal milk 
production. All text messages are found in attachment. Content is informed by 
breastfeeding literature regarding common barriers and reasons for breastfeeding 
cessation as well as causes of frustration during early breastfeeding.  
Data collection: The intervention group will be polled when infants turn two months, four 
months, and six months regarding their breast feeding status through Telerivet via SMS 
messaging. If participants do not respond to automated SMS messaging, participants will 
be contacted by the research site coordinator within two weeks of receiving the survey. 
They will be contacted through phone calls by local cellphone carrier. If participants do 
not respond, she will be contacted through Whatsapp messenger application via 
messaging and/or phone calling. The same survey questions will be asked: if they are 
breastfeeding at all, if they are breastfeeding exclusively in the last 24 hours, 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. Exclusive breastfeeding will be defined as 
giving only mother’s breastmilk in the 24 hours preceding the interview. Diarrhea is 
defined as any watery stool with frequency unspecified.  We recognize the limitation of 
this lack of clear definition; however, this is the current diarrhea definition used by the 
DHS in Honduras. This has been used to determine the current prevalence of diarrheal 
illnesses in infants less than 6 months. All replies from mothers will be stored on a 
password protected, secure survey in Telerivet, and/or a password protected, secured 
excel sheet database (those responded to on phone verbally or by whatsapp), and then 
transferred to a password protected, secure Red Cap database. 
7) 
Data and/or Specimen Management and Confidentiality 
Pre-Intervention Group 
Each participant will be assigned a study ID number and no identifying data will be obtained. We will 
ask each mother if they have participated yet in order to prevent double sampling. The list of the 
study ID numbers with associated responses will be transcribed on a master excel sheet. This will be 
stored on a password protected secured server. Only key study personnel who have received IRB 
training will have access to the database.  
 

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Intervention Group 
Each participant will be assigned a study participant ID number. List of participants including name, 
phone number, and the date of their infants’ birth and their ID will be kept in a master excel 
spreadsheet. Data will be collected on a separate excel sheet that identifies participants only by their 
study ID. Both of the documents will be stored in a password protected secured database.  Minimally 
necessary number of team members will have access to the passcode to the data base. In addition, 
all team members will undergo IRB training.   
 
Statistical Methods:  
Descriptive statistics will be used to characterize demographics of participants in the interventional 
study, which will then be compared to the those in the baseline survey with Pearson Chi-square test 
and Student’s t-tests. Differences in proportions of mothers practicing exclusive breastfeeding  [EBF 
(receiving nothing besides breastmilk in the last 24 h)] and mixed feeding (breastfeeding and other 
type of feeds in the last 24 h) at 2,4 and 6 months in the intervention group vs. the pre-intervention 
baseline survey will be compared with Chi-square tests, as will proportion of infants experiencing 
diarrheal illness in the past 2 weeks at each age. 
 
Descriptive statistics will be used to present information regarding types of food introduced at different 
ages, and chi-square to assess differences in specific foods introduced between pre-intervention and 
intervention samples. Data will be stored and accessed via REDCap.  Analysis will be done with 
statistical assistance from UC Davis Clinical and Translational Science Center. An interim analysis is 
planned to ascertain that data capture from the electronic phone-based survey is successful. 
 
Sample Size / Power Analysis:  
In order to have power of 0.8 with a two-sided alpha value of 0.05, using an established baseline 
sample proportion of 10.9% (exclusively breastfeeding at 2 months of life) and assuming as our 
desirable detectable goal a true probability of 19.9% with intervention, we will need a sample size of 
at least 208 intervention respondents at 2 months. Recruitment is anticipated to continue until this 
number of participants have responded.  
 
 
8) 
Data and/or Specimen Banking 
N/A 
 
9) 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
N/A 
10) Withdrawal of Subjects 
There are no circumstances under which subjects will be withdrawn from the research 
study without their consent. The only instance participants will be withdrawn will be due 
to consent of the primary phone user and/or study participant. 

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11) Risks to Subjects 
Potential exposure of personal information is the only risk associated with participating in this 
study. This risk will be minimized by proper securement of data as described above.   
 
12) Potential Benefits to Subjects 
Benefits for participants in the intervention group include education on breastfeeding techniques 
and how to avoid or address common problems as well as additional support and 
encouragement for breastfeeding.  
 
Although there is no direct benefit for mothers who will be interviewed in pre-intervention cross-
sectional sample group, the data they provide will help establish the prevalence of breastfeeding 
on the island.  
 
13) Multi-Site Research 
 
Intervention: Public Hospital Roatan is the only public hospital on the island of Roatan. It 
has the only public birthing unit on the island.  
Regular calls with the on-site study team will be conducted. All study personnel in Roatan, 
Honduras as well as those involved in the study at UC Davis will complete IRB training. IRB 
approval has been obtained in Honduras.  
 
14) Community-Based Participatory Research 
Prior to starting enrollment, a qualitative study was completed (separate IRB). The aims 
of this qualitative study were to discover what women perceived to be the barriers to 
breastfeeding, what influenced them when choosing their method of infant feeding, and 
what healthcare interventions might have encouraged them to breastfeed. The findings 
of the project will be used to ensure that our ensuing breastfeeding intervention will be 
culturally sensitive and community-based. 
15) Sharing of Results with Subjects 
The results of this study will not be directly shared with individual subjects.  
16) Prior Approvals 
IRB approval has been obtained in Honduras and is attached.  
 
17) Provisions to Protect the Privacy Interests of Subjects 
 
Intervention Group 
Each participant will be assigned a study participant ID number. List of participants including name, 
phone number, and the date of their infants’ birth and their ID will be kept in a master excel 
spreadsheet. Data will be collected on a separate excel sheet that identifies participants only by their 
study ID. Both of the documents will be stored in a password protected secured database. Minimally 

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necessary number of team members will have access to the passcode to the data base. In addition, 
all team members will undergo IRB training.   
 
18) Compensation for Research-Related Injury 
N/A 
19) Economic Burden to Subjects 
Participants will be charged for sending text messages in response to our polls at 2, 4 and 6 months. 
To off-set any costs for participating in this study, we will provide 20 Lempiras at time of enrollment, 
and 70 Lempiras phone credits after responding to the 2 month poll (must include sending a response 
to exclusive breastfeeding in last 24 hour question).