Study design
In 2016-2017, a baseline cross sectional survey was performed to assess EBF prevalence of mothers with infants aged less than 6 months old (n=227) from a convenience sample of mother-infant dyads attending 3 different clinics in Roatan for routine childcare. Breastfeeding status, infant feeding practices and diarrheal disease incidence were queried, and infant ages were classified into 2, 4 and 6 months.
Subsequently in 2017-2018, we studied the effect of a targeted client communication via mobile devices (TCCMD) intervention (n=582) on the rate of exclusive breastfeeding (EBF) in Roatán, Honduras with 582 new mother-infant dyads, with the primary outcome defined as exclusive breastfeeding at age 2 months. Secondary outcomes were EBF at 4 months and 6 months, any breastfeeding and diarrhea incidence. Women were recruited from the post-partum ward at Roatán Public Hospital. Inclusion criteria were recent delivery of term infants ≥ 37 weeks gestational age, ≥18 years of age, an emancipated minor (or with parental consent if < 18 years of age), intent to breastfeed, own a phone that can receive and send SMS messages, literate (self-reported ability to read English or Spanish) and interested in receiving text messages regarding EBF. Exclusion criteria were inability to consent, illiteracy or incarceration. We collected outcome data at the infants’ 2-, 4-, and 6-month birthdays (within a window up to 2 weeks thereafter). The survey was administered by text message with follow-up phone calls to non-respondents. We evaluated effectiveness of the intervention by comparing EBF rates at 2 months in intervention study to historical controls. Figure 1 summarizes the intervention study design adapted from the Consolidated Standards of Reporting Trials (CONSORT) template.
Ethics Approval and Consent to Participate
Institutional Review Board approval for this study was obtained from the University of California, Davis (UC Davis), University of California, San Francisco (UCSF), and Catholic University of Honduras Committee of Research Ethic (Universidad Católica de Honduras/Comité de Ética de Investigación). Informed verbal consent was obtained for the baseline survey as it was exempt from requiring written informed consent. Written and verbal informed consent in English or Spanish (based on participant’s preference) was obtained during intervention study recruitment.
Setting
Roatan, Honduras is an island located 65 kilometers of the northern coast of Honduras in the Caribbean Sea. It has an estimated population of 110,000 (2020 Census) and unknown breastfeeding practices prior to this research. There is one government hospital, Roatan Public Hospital, which provides free maternal and child healthcare both inpatient and outpatient. There are three additional public pediatric clinics: Oak Ridge; French Harbor; and Los Fuertes; and one non-profit outpatient clinic, Clinica Esperanza.
Participants and recruitment
Baseline survey was conducted from August 2016 to May 2017. Mothers were recruited while waiting to receive routine pediatric care for their infant at all five pediatric clinics: Roatán Public Hospital, Oak Ridge, French Harbor, Los Fuertes, and Clinica Esperanza. These clinics serve the majority of the island population, thus a representative sample of island residents. Mothers were eligible to participate if (1) infant was within 2 weeks of their 2-, 4- or 6-month birthday, and (2) had not previously completed the survey.
Intervention study participants were enrolled from September 2017 to May 2019 solely from the postpartum ward at Roatán Public Hospital, providing access to most women delivering infants on the island. Post-partum mothers at Roatán Public Hospital were recruited via a research assistant based on aforementioned inclusion and exclusion criteria.
Historical Control Group
Mothers in the historical control group were consented and invited to complete an orally administered questionnaire containing sociodemographic questions (i.e., age, education level, occupation, household living conditions, area of residence, and infant gender), past and current breastfeeding practices, recent infant diarrheal incidence (last 2 weeks), reasons for breastfeeding discontinuation if applicable, and whether they had met their own breastfeeding or breastmilk feeding intentions. Economic status was assessed indirectly through questions of household living conditions, including access to electricity, piped water in the home, number of bedrooms and number of individuals living in the household (similar to Honduran DHS).
Intervention
The intervention messages were written in both English and Spanish. Upon enrollment, mothers completed a sociodemographic questionnaire and were sent a sample text survey in their preferred language to ensure text messages were received. Mothers completed the test survey to practice text response and to trouble shoot any technical issues. If mothers did not have their phones at enrollment, mothers verbally agreed to complete the test survey when possible. Mothers had the option to view three animated videos (created in collaboration with Aerial Contrivance Workshop™) providing information regarding breastfeeding and latch techniques, recognizing infant feeding cues, and encouragement to practice self-care and ask for help.
The duration of the intervention was 26 weeks during which a total of 158 messages were sent, including links to the videos. Messages were concentrated in the first 31 days of enrollment (total 99 messages), when obstacles to establishing EBF are most common. Incentives for survey completion at 2, 4, 6 months were provided at an equivalent of $1 per poll in either cash or talktime credit. Messages were sent from a computer-based, SMS interactive platform using Telerivet (https://telerivet.com) software program. Messages were sent through both Honduran cell service providers (Tigo™ and Claro™), with no cost to users receiving messages.
Intervention Messages
The intervention group received promotional and educational breastfeeding messages from the time of enrollment to 6 months post-delivery. Intervention messages were developed based on standard breastfeeding guidelines from WHO,12 the American Academy of Pediatrics13 and the Academy of Breastfeeding Medicine; 14,15,16,17,18,19,20,21,22 barriers found in focus groups we performed locally23, the California Baby Behavior Campaign24,25 and consultation with breastfeeding medicine experts and local Honduran pediatricians. Local physicians cited lack of education, cosmetic concerns, and difficulty with technique as common barriers to breastfeeding. The messages sent included recognizing newborn hunger cues, methods and positions to obtain a comfortable latch, normal infant sleep patterns, appropriate number/frequency of feeds, maternal milk production, and other education regarding infant sleep, breastfeeding techniques, complications, specific needs and encouragement for new mothers.
Primary and Secondary Outcomes
Our primary outcome was the proportion of 2-month-old infants who were exclusively breastfed during the last 24 hours before completing the response survey. Secondary outcomes were: (1) proportion of infants exclusively breastfed at 4 and 6 months; (2) diarrheal incidence at age 2, 4 and 6 months; and (3) proportion of infants receiving any breastfeeding at 2, 4 and 6 months
Definitions
Exclusive Breastfeeding
Exclusive breastfeeding was defined as giving mother’s breastmilk in the 24 hours preceding the baseline or intervention follow up survey and not giving any other foods or fluids as defined by the WHO.12
Subjects’ data were included in analyses for both historical control and intervention groups if they were in the age range of 2-, 4- or 6-months of age to 2-, 4- and 6-months plus 2 weeks of age; thus, 61-75 days, 122-136 days, and 183-197 days, respectively.
Diarrhea
Diarrhea was defined as “stool more watery than usual” (baseline) or “any watery stool” (intervention) with unspecified frequency.
Interventional Study
Data collection
SMS surveys
Mothers were sent follow-up surveys regarding their breastfeeding status at 2, 4, and 6 months postpartum through Telerivet. All replies from mothers were stored on a password protected, secure survey in Telerivet, and consolidated to a password protected, secured excel database.
The multiple-choice survey questions asked: (1) Did you give breast milk (any amount) to your baby in the last 24 hours? (yes/no), (2) How old was your baby when you last gave him breastmilk? (multiple choice age-ranges) (3) In the last two weeks, has your baby had any diarrhea (any watery stool)? (yes/no), (4) Did you give your baby anything other than breast milk in the last 24 hours? (yes/no), and (5) What did baby receive in the last 24 hours? Choose all that apply: water, tea, anise, infant formula, fruit juice, cereal, breastmilk, other, and/or none.
Telephone and messaging follow-up
Per protocol revision due to loss to follow-up, from October 2018 through June 2019, if participants did not respond to the automated SMS surveys, mothers were contacted via local phone calls within two weeks and performed survey verbally. If no response was received, participants were further contacted via Whatsapp secured-messenger application by messaging and/or calls. A maximum of four attempts were made to elicit a response within the two-week window.
Lost to Follow up/Messaging failures
Responses were categorized as one of the following: (1) completed response to primary outcome, and (2) incomplete response to primary outcome, which included unresponsive/lost to follow- up efforts, withdrawn from study, missing/changed phone numbers, and network error. Please see Figure [1], flow chart of study subjects.
SMS messaging was disrupted for a period of three months due to the loss of cellular service to the Telerivet-linked primary phone, and another period of one week due to delayed Telerivet subscription renewal. Survey responses during this time were lost to follow-up. The disruption affected roughly 60 two-month survey outcomes, and thus the enrollment sample size was increased accordingly. We analyzed by ‘intention to treat’ (including these mothers with network errors) as well as ‘treatment received’ (excluding the dyads who did not receive those messages).
Data Collection:
Quantitative data were coded and collected via (1) text message responses automatically submitted to Telerivet server from which we could monitor data and generate reports, and (2) manual input via phone call or Whatsapp messaging to a password protected, secured excel database.
Data Analysis:
Primary and secondary outcomes from the historical control and intervention groups were compared by difference in proportions, with Chi-square and Fisher’s Exact tests performed to detect statistical significance.
A multivariable logistic regression that adjusted for demographic and socioeconomic factors was used to calculate the odds ratio for EBF between intervention and historical control groups at 2, 4 and 6 month infants. The Kaplan-Meier survival curve and Log-Rank test was used to portray and compare the length of time that mothers continued any breastfeeding. All statistical analyses were performed with SAS version 9.4 (SAS Institute Inc). Hypothesis tests were 2-sided and evaluated at a significance level of 0.05.