Feasibility of a Touch Screen Computer Based Breast-feeding Educational Support Program
Phase: NA
Conditions: Pregnancy Related
Sponsor: University of Nebraska

Feasibility of a Touch Screen Computer Based Breast-feeding Educational Support Program 
NCT03308058 
March 5, 2012 

 
I. 
Background and Significance 
Breast-feeding is an effective way to promote infants and mothers health because it has many positive and long 
lasting impacts on health. The Healthy People 2020 goals set targets for initiation and duration of breast-feeding1. 
Currently, 75% of babies born in the U.S. are initially breastfed, but rates fall to 43% at 6 months and 22% by 12 
months1. The American Academy of Pediatrics recommends that infants be fed only breast milk for the first 6 
months of life, but only 13% of babies in the U.S meet this breast-feeding standard. Healthy People 2020 aims 
to increase rates to 82% ever breastfed, 61% at 6 months, and 34% at 1 year1. Exclusive breast-feeding goals 
are set for 44% at 3 months and 24% at 6 months1. 
According to data from the National Immunization Survey (NIS), only 30.5% of the children included in the survey 
who were born in 2004 were exclusively breastfed at 3 months and that number dropped to 11.3% by 6 months 
of age2. These exclusive breast-feeding rates are very similar in Hispanic women in the United States, at 30.9% 
and 11.6%, respectively2. Additionally, no state in the United States met the Healthy People 2010 objectives for 
75% of infants being exclusively breastfed immediately postpartum and 50% by 6 months2. Current breast- 
feeding rates fall short of these goals. Many mothers wean early or initiate complementary feeding of their 
children before it is recommended and advantages of breast-feeding and breast milk are not realized. The 2006 
National Health and Nutrition Examination Survey (NHANES) reported that only 43% of mothers less than 20 
years old initiated breast-feeding compared to 65% of mothers in their 20s, and 75% of those older than 30 
years3, 4. Despite substantial evidence of maternal and infant benefits of breast-feeding, adolescent mothers 
initiate breast-feeding less often and maintain breast-feeding for shorter durations. The 2006 National Health 
and Nutrition Examination Survey (NHANES) reported that only 43% of mothers less than 20 years old initiated 
breast-feeding compared to 65% of mothers in their 20s, and 75% of those older than 30 years3. The National 
Immunization Survey (NIS) reported similar initiation rates of 51%, 71% and 79% respectively4. The figures for 
mothers in these age groups who continued to breastfeed at 6 months were 19%, 36%, and 50%4. 
Significance of Breast-feeding: Breast milk provides the optimal nutrition for infants and offers health benefits 
as well as immunity from infections. Human breast milk not only provides complete nutrition for the full physical 
and mental development of healthy infants in the first critical months of life, but also protects against common 
childhood infections and diseases throughout childhood and into adulthood. Babies who are not fully breastfed 
for the first 3–4 months of age have been shown to suffer health problems such as gastroenteritis5, 6, respiratory 
infection5, otitis media7 and urinary tract infection7. Maternal benefits of breast-feeding can include more rapid 
return of postpartum uterine tone and postpartum weight loss, delay of ovulation and decreased risk of breast, 
ovarian, and endometrial cancers8. 
 
Challenges of breast-feeding: The correlates of breast-feeding include attitudinal, socio-economic, familial 
and physiological factors9-11. The socioeconomic correlates include maternal education, household income and 
maternal employment12-14. Socioeconomic correlates of breast-feeding are rarely studied for US rural women 
despite the fact that over 25% of the US population is rural15. Rural residents are at a disadvantage compared 
with urban residents15 due to lower average education levels, lower incomes, higher fertility, more teen births, 
geographic isolation, and inadequate economic, social welfare and health resources15. Socioeconomic 
disadvantages faced by adolescent mothers place their infants at greater risk for infant morbidity, mortality and 
developmental delays16-18 and increase the importance of protective factors available through breast-feeding. 
Various factors that hinder breast-feeding duration include breast-feeding knowledge, well-intentioned but 
inaccurate advice from family members and friends, perceived inadequate quantity of milk supply and 
perceptions of social disapproval of breast-feeding19. There is a decline in breast-feeding in Hispanic women 
who immigrate to the United States and become acculturated. The degree of acculturation is comprised of 
various factors including generation, length of time in the United States, and perceived similarity to Americans20. 
The literature on acculturation in Hispanic breast-feeding women is limited. Prior study found that increased 
years in the US was associated with shorter duration of breast-feeding21. Teens raised in the US interpreted 
public breast-feeding as degrading or embarrassing22. Another influence on the decision to breastfeed is that 
recently immigrated Hispanic women may have fewer family members present to support and guide their 
decision and positive social support can mediate the challenges mother encounter with breast-feeding23 and 
those with greater social support are more likely to breastfeed24, 25. Other factors that hinder breast-feeding 
duration include: (a) lack of support for prolonged breast-feeding26; (b) ambivalence and misinformation27; (c) 
younger age28; and (d) especially in rural settings15. Women who describe themselves as somewhat confident in 
regards to breast-feeding are three times more likely to discontinue breast-feeding during the first 6 months 

postpartum than are those who describe themselves as very confident29. Self-efficacy is a dynamic process 
throughout the postpartum period, especially during vulnerable cessation periods30. Low maternal confidence 
has been associated with the perception of inadequate milk supply and is related to early discontinuation of 
breast-feeding, especially during the first 2 weeks30. Only one descriptive study (n=172) was found on the use 
of technology to assess breast-feeding knowledge of childbearing families31. Lack of knowledge was found 
related to milk supply and to pumping in special circumstances31. Specific individualized interventions, especially 
during the initial critical 2-6 week period, are needed to prevent deterioration in intention levels for breast-feeding 
for 6 months and breast-feeding self-efficacy levels within the first 2 weeks postpartum which could lead to the 
decision to discontinue breast-feeding31. 
A prior study showed significant improvement in the knowledge gained about the chronic illness self management 
among rural women using computer based health education32. Increase in human immunodeficiency virus (HIV)/ 
acquired immune deficiency syndrome (AIDS) knowledge and self-efficacy was seen when intent to treat model 
was implemented using internet. The study demonstrated the acceptability and efficacy of the internet for 
delivering HIV prevention messages to rural men who have sex with men33. 
The objective of the proposed study is to explore acceptance of bilingual, interactive touch screen computer 
based breast-feeding educational program and also explore its effect on improving breast-feeding knowledge, 
breast-feeding self-efficacy and partial to exclusive breast-feeding among pregnant Hispanic rural women. 
Significance 
AHRQ encourages grant applications that propose research that focuses on the health care for AHRQ priority 
populations with specific emphasis in the following areas (1) explaining disparities in health care and clinical 
practice; (2) implementation of research and interventions that aim to reduce disparities in priority populations 
and settings; (3) addressing known gaps in research dealing with priority populations; 4) development of 
methods to address the heterogeneity of priority populations, small sample sizes and to improve outcomes    for 
priority populations in AHRQ sponsored research; 5) research on cross cutting issues involving mu ltiple priority 
population groups and settings (for example, disabled children, minority women, rural maternal and child health, 
etc); and 6) development of innovative service delivery models for settings in which priority populations receive 
care. The proposed pilot study meets the research priority needs of AHRQ. 
 
To our knowledge, this is the first ever study to deliver breast-feeding education through use of a touch screen 
computer based program in a rural setting. The study will help to develop breast-feeding educational modules 
tailored to the needs of the Hispanic women living in rural settings. The study further explores the feasibility of 
utilizing bilingual; touch screen computer based breast-feeding educational programs to promote breast-feeding 
among Hispanic rural women who are difficult to reach, have limited access to health information and language 
barriers. The current proposed study will help advance our understanding to use health information technology 
as a medium to disseminate bilingual health education programs in rural settings. The proposed computer based 
breast-feeding educational program will continue even after the duration of the grant. The research team will 
continue to update the educational content and develop new educational modules necessary to make program 
adoption successful. The findings of the program will be presented to the relevant stakeholders including AHRQ 
six months post completion of the grant. Further, this approach can be used to disseminate tailored health 
educational programs for various other health conditions in underserved populations across various other 
settings. This exploratory study will lay a foundation for a larger multicenter randomized controlled clinical trial to 
evaluate the impact of computer based educational intervention to promote sustainability of breast-feeding 
among women across diverse settings. The proposed study will help demonstrate the utilization of 
telecommunications technology as an effective means for reaching geographically and socially isolated 
individuals. 
I. Conceptual framework 
The framework for the proposed study is the Sustained Breast-feeding Framework based on Fishbein and 
Ajzen’s Predicting and Changing Behavior Theory [PCBT] 34. PCBT proposes that attitudes, perceived norm, 
and perceived behavioral control are inter-related and that together they influence intention to engage in the 
behavior which is proposed to be the primary determinant of behavior. The PCBT has been used previously to 
predict behaviors such as weight loss, physical activity and self-efficacy for healthy eating in Mexican American 
populations35-37. 

Perceived norm 
Social influences 
Perceived behavior control 
Self-Efficacy 
Breast-feeding Self-Efficacy 
Intent to Breastfeed 
Attitude/Beliefs 
Breast-feeding beliefs 
Attitude 
 
 
 
 
 
 
 
Intent 
Behavior 
 
 
 
 
 
 
 
Figure1. Sustained Breast-feeding framework 
Attitude/Beliefs. Attitude is defined as an individual’s evaluation either favorably or unfavorably for a specific 
behavior34. This study will measure this concept using survey questions from the revised breast-feeding attrition 
prediction scale [BAPT] 38, 39, and will be adapted for the PEMT to determine the mother’s attitude about breast- 
feeding. 
Perceived Norms. The framework variable perceived norm or social pressures is described as the pressures 
to perform a given behavior. The mother’s perception of influence by her social network to perform a specific 
behavior will be measured by questions developed for the PEMT. Mexican American mothers have been found 
to follow nutritional advice of family members over that of their health care providers, (e.g., doctors, nurses, WIC 
educators) 40. Questions from the revised BAPT38, 39 will be adapted for the PEMT to measure the mother’s 
perception of influence from her social network. 
Perceived behavioral control, (self-efficacy). It is proposed to be the extent that an individual (mother) 
believes that they are capable of performing a behavior including access to all resources. This concept will be 
measured using the breast-feeding self-efficacy scale [BSES] 41, 42, that reflects past experiences and anticipated 
obstacles. 
 
Intent. It is defined as readiness to engage in a behavior. It will be measured by an intention question related 
to the mother’s perceived intent to breastfeed for the recommended 6 months. The question has been developed 
based on Fishbein & Ajzen’s guidelines34 and is “How likely do you intend to breastfeed for 6 months?” 
 
Behavior. It is observable events directed at a target in the context of which it is performed and the time that it 
is performed. The behavior outcome is partial or exclusive breast-feeding. 
 
Design of Patient Education and Motivation Tool (PEMT): PEMT is a touch screen, computer based interactive 
health education program designed based on a variety of cognitive-behavioral theories43. PEMT facilitates health 
information and messages to be adapted depending on the psychosocial elements including attitude, self- 
efficacy, expectations, personal norms and social influences44-46 (Table1). PEMT has 3 key components including 
(a) screening gathers individual socio-demographics, knowledge, attitudes and practice through a series of 
questions; (b) learning component delivers educational material in a structured format. The entire educational 
material is broken down into series of modules, each module into sub-modules and each sub-module into a series 
of educational messages. Each message is then presented using various multimedia formats (such as audio, 
video, text and images) and (c) evaluation component gauges effectiveness of the program by assessing change 
in knowledge, attitudes and practices of the individuals. The main objective of the PEMT is to 
Breast-feeding duration 
(partial or exclusive) 

present health information in an interactive tailored manner considering multiple factors influencing health status 
and health behaviors. 
 
Theory 
Purpose 
PEMT Learning Component 
Information 
Processing 
theory47 
Information chunking means presenting 
information as a meaningful unit and short 
term memory is limited 5 to 9 chunks of 
information 
Each screen has a series of short educational 
messages 
Constructivist 
Theory48 
Present information in a structured format 
simple to understand 
The information is presented in a structured 
format with a series of several educational 
modules. Each module is broken down into 
sub-modules and each sub-module is broken 
down into a series of educational messages. 
Cognitive 
Flexibility theory49 
The information presented should be 
highly interconnected so that it is relevant 
to the learner 
The information is presented related to the 
responses to the questions provided during 
the screening component. 
Cognitive 
Flexibility theory49 
Multiple Content Formats should be 
available including audio, images and text 
The information is presented in multiple 
formats including text, audio, images, and 
animation. The patients can turn on/off the 
audio at their own will 
Cognitive 
load 
theory50 
Minimize working memory load 
The information on the screen is presented as 
text enhanced using images and animation to 
make it easy to understand 
Behavioral theory 
and 
operant 
conditioning51 
Feedback given based on responses 
The positive prompts or encouragement is 
given based on a correct response and an 
educational message is reinforced during an 
incorrect response. 
Table1. Conceptual framework of existing PEMT 
 
PEMT interaction metrics: Another important aspect of PEMT is that it captures individual’s interactions with 
this interactive educational support program and generates usage metrics. These cluster of usage metrics 
include user id, session id, screen id, number of screens viewed, screen viewing time, chunk viewing time, 
navigational patterns assessed by capturing the buttons clicked on the screen. Usage is clearly an important 
characteristic in assessing the popularity of a computer mediated health education programs with most usage 
data being derived from the digital logs that record user activity on a continuous and real time basis. The logs 
provide data on what people have done; this gives logs their strength, and differentiates them from other data 
capture methods like interviews and questionnaires. Considerable knowledge extracted from these digital usage 
logs and knowledge is used to decide what content need to be presented, the media that will be used to present 
the content, and the order in which the content will be presented based on user preferences. Further, this 
information is used as an indirect measure of motivation to assess individual’s engagement to the program, 
learning pathways, preferences and their receptiveness to learning. We will improve breast–feeding related 
attitudes, self-efficacy and knowledge by implementing sustained breast-feeding framework to the existing PEMT 
to improve partial or exclusive breast-feeding (Figure2) 
 
 
 
Increase 
knowledge/attitud 
e/beliefs 

 
 
Figure2. Adapting PEMT to Sustained breast-feeding framework 
 
 
II. Preliminary Data 
PEMT was designed by Joshi (PI) and has been previously implemented for various disease conditions such as 
asthma, influenza, multiple myeloma, multiple sclerosis and bilingual nutrition education program for Spanish 
speaking mothers44- 46(Figure3). 
 
Figure3. Existing PEMT programs and bilingual nutrition program for Spanish speaking mothers 
The objective of these initial evaluation studies of PEMT were five–fold: (i) to assess the feasibility of a touch 
screen computer based educational program in diverse settings such as Emergency room, waiting rooms of the 
outpatient clinics, and primary care settings (ii) to gauge change in knowledge, attitudes and practice towards 
diseases such as asthma and influenza, (iii) to gather and describe user interactions with the computer, (iv) to 
understand health information seeking patterns of the individuals and (v) to assess acceptance of PEMT. PEMT 
has been easy to use even in low income Spanish speaking Latino immigrant populations with no prior computer 
experience. However, this study only assessed feasibility of using touch screen kiosk as a medium to facilitate 
delivery of health education and did not include any algorithm for tailored messages. The study was also 
conducted in an urban tertiary setting and did not include any participants from a rural setting. Analysis of the 
usage data of the computer based program showed association between the times spent to view the various 
educational topics, the specific educational topics viewed, the demographic characteristics and asthma 
knowledge44. PEMT interaction metrics data gathered during individual interactions with the PEMT helped 
identify the educational modules that were most viewed by the diverse users. The research team (SW, TA & KR) 
has also conducted a variety of studies in multi-rural sites related to prevention of chronic illnesses in infants and 
PEMT 
Increase self- 
efficacy 
Increase 
Intent to 
Breast feed 
Perceived norms 
Increase Breast- 
feeding duration 
(partial or 
exclusive) 

children19. They have performed studies to promote sustained breast-feeding in rural Caucasian, Native 
American, and Hispanic mothers19. A multi-site rural intervention study for sustaining breast-feeding in 
primiparous women at three sites in Wyoming and Nebraska was also conducted; therefore they are aware of 
some of the challenges of multi-site rural research. 
III. Procedures for pilot testing Computer based Breast-feeding educational support program 
 
The major objectives of this pilot study is to (a) develop breast-feeding educational content both in English and 
Spanish (b) Modify existing PEMT to develop interactive tailored, computer based breast-feeding educational 
support program and (c) pilot test the Computer-based Breast-feeding Educational Support program to educate 
Hispanic rural pregnant women to improve breast-feeding knowledge, breast-feeding self-efficacy and partial 
breast-feeding. The following tasks will be performed to achieve the proposed study aims. 
(a) Developing and Finalizing Breast-feeding educational content 
The expert panel comprising of multidisciplinary team of researchers including Drs. Joshi, Wilhelm, Aguirre, 
Rodehorst, Brigitan and Wambach will work closely to develop a detailed outline of the educational modules. 
Qualitative data gathered during the 2 focus groups can add an important dimension for research on facilitating 
behavior change. One highly valued and widely-used method for qualitative inquiry is the use of focus group 
interview. This method can capture evolutionary and transformational developmental dynamics. These are 
typically based on homogenous groups (people of similar backgrounds and experiences to participate in a group 
interview about major issues that affect them) 52. Two separate focus groups one in English and Spanish will be 
performed with six Hispanic rural women with history of previous pregnancy will be enrolled at the Regional West 
Medical Center (RWMC), Scottsbluff, NE. The focus group of 2 hours duration will be performed at the antenatal 
clinic at RWMC during months 2 and 3 of the study. The focus group will help examine factors that affect the 
decision to continue breast-feeding in pregnant Hispanic rural women and will guide development of bilingual 
(English and Spanish) breast-feeding educational modules during months 4 and 5 of the study (Appendix A). Dr. 
Aguire and Lupe Salazar (Consultant) will be responsible for subject recruitment, focus group assessments and 
would act as a moderator and respond to questions and comments during the focus groups. Ms. Salazar is a 
community person who has worked with Minority Health, Nebraska Dept of Health and Human Services and is 
certified in Spanish translation. The focus group interviews, analysis and development of Breast-feeding 
Educational modules in English and Spanish will be finalized during first 5 months of the study. Each subject will 
receive $50 gift card for their participation in the focus group. 
(b) Computer-based Breast-feeding educational Support Program 
 
We will modify existing touch screen, computer based interactive PEMT platform to deliver bilingual, Breast- 
feeding educational support program. The existing PEMT platform allows users to dynamically change the 
educational content either to English or Spanish. The modification of the existing PEMT will occur during months 
5-7 and will include several stages: 
• 
PEMT modification design: The research team including Drs. Joshi, Wilhelm, Aguirre, Rodehorst, 
Brigitan and Wambach will work closely to facilitate computerized tailoring based on the developed 
breast-feeding educational modules discussed previously (Section IV a). The finalized breast-feeding 
educational content will be available both in Spanish and English and the subject can use either language 
to navigate through the program. The modification of the existing PEMT to adapt it to deliver computer 
based breast-feeding educational support program will be done during months 5 and 6 of the study. 
 
• 
Tailoring: It is a process of creating individualized communication and is an assessment-based approach 
in which individuals provide personal data related to a given health outcome53. Those data are then used 
to determine the most appropriate information or strategies to meet each individual unique need. An 
important theoretical basis for tailoring comes from Elaboration Likelihood Model54, which states that 
people are more likely to actively and thoughtfully process information if they perceive it to be personally 
relevant53. Messages processed in this way tend to be retained for a longer period of time and are more 
likely to lead to permanent attitudinal change. The entire finalized breast-feeding educational content will 
be broken down into series of modules, each module into sub-modules and each sub-module into a series 
of educational messages. The computer based program will have the ability to deliver breast- feeding 
education in varied learning styles such as text-only, audio and text, or text, audio and images to 

account for health literacy of the individuals. The program will simplify the design and create multiple 
tailored versions of printed materials instead of using a single standardized version. The tailoring 
algorithm will be developed based on health literacy levels, prior breast-feeding knowledge and attitude 
towards breast-feeding practices. For e.g. If a person has low literacy the information will be presented 
as images and graphics. Similarly information specific to those topics will be presented in which the 
individual has poor breast-feeding knowledge. Messages will be tailored to perceived breast-feeding 
concerns. Tailored educational messages might focus on subjects with poor breast-feeding skills and will 
educate and empower individuals through use of motivational prompts. The program aims to deliver 
specific messages as computer provides a medium to adopt tailoring with no time lag and multimedia 
capabilities. 
 
• 
Expert Pretesting using Heuristic evaluation: The proposed Computer based Breast-feeding 
Educational Support program will undergo usability assessment during modification of the existing PEMT 
program. Heuristic evaluations, which are often referred to as “expert reviews” or “usability audits”, are 
an efficient way of assessing the usability of information technologies and are particularly useful early in 
the development process when it is least expensive to make changes. Dr. Sears (Consultant), a well 
known expert in usability will formalize this process while working with Dr. Joshi (PI). We will employ a 
variant of this technique, often referred to as a heuristic walkthrough, where evaluators (Joshi and Sears) 
are given a set of representative tasks to guide their assessments. These reviews are conducted 
independently and the results are subsequently combined. The severity of the issues identified can then 
be assessed and modifications to the system prioritized. One advantage of this methodology is that it can 
be employed as soon as a mock-up of the system is available, allowing issues to be identified and 
corrected before a semi-functional prototype is developed. Computer based Breast-feeding Educational 
Support program will provide modular, culturally relevant, bilingual (English/Spanish) breast-feeding 
education tailored to the needs of the mothers. For these assessments, we will identify representative 
tasks including both critical and high frequency activities. This expert pre-testing using heuristic 
evaluation will be performed during months 5-6 of the study. 
 
• 
Usability and User testing: We will recruit six Spanish speaking pregnant Hispanic rural women at the 
RWMC, Scottsbluff to interact with the system. They will be enrolled at the Regional West Medical Center 
(RWMC), Scottsbluff, NE. Dr. Aguire and Lupe Salazar (Consultant) will be responsible for subject 
recruitment. Information flyers will be available at the RWMC to inform the subjects about he study. These 
subjects will not be part of the actual study. After a brief introduction to the system, study subjects will be 
asked to complete a predefined set of tasks by interacting with the system and the duration of this 
interaction will be around 30 minutes. We will have a think aloud protocol that will involve participants 
thinking aloud as they perform a set of specified tasks. Users will be asked to say whatever they are 
looking at, thinking, doing, and feeling, as they go about their task. This will enable observers to see first- 
hand the process of task completion. Notes and test sessions will be audio taped of everything that users’ 
say, without attempting to interpret their actions and words will be taken. During these assessments, we 
will gather basic quantitative results including information about the time required to complete tasks and 
the errors encountered using the usage data metrics as described previously (Section II. Conceptual 
framework). A likert scale survey will be used to assess user satisfaction with the computer program and 
any recommendations study subjects may have to improve the system. The results of the user testing 
will be followed by incorporating the recommended changes to the design of the Computer-based Breast- 
feeding educational support program during months 6 and 7. The final program will be deployed during 
month 8 of the study period. 
 
 
IV.Research Design and Methods 
 
The proposed pilot study is a two-group repeated measures quasi-experimental design that will be used to 
explore the effect of using Computer based Breast-feeding Educational Support program to promote breast- 
feeding in rural Hispanic women. (Figure4) 
 
 
 
 
Control 
Confounders 
Socio-demographics 
Breast-feeding status 
Primary Outcome 
Partial or Exclusive Breast-feeding till 
six months (Proportion) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure4.Research Design 
The subjects will be enrolled at RWMC, Scottsbluff and randomly assigned to either intervention (bilingual 
Computer based Breast-feeding Educational Support program) or attention control (bilingual breast-feeding 
printed educational material) groups during the subject’s prenatal visit (i.e. anytime during last six weeks of their 
pregnancy). Once randomized, baseline information will be gathered in both the groups as outlined in Figure5. 
The difference between the two study groups is that subjects in the intervention (bilingual Computer based 
Breast-feeding Educational Support program) will record their baseline assessment on a computer and receive 
tailored breast-feeding education compared to the attention control (bilingual printed breast-feeding educational 
materials) who will record their baseline information on paper (Figure5) and receive printed breast-feeding 
educational material. Using self report responses of the individuals in the intervention group (bilingual computer 
based breast-feeding educational support program), the decision logic and algorithm will process the information 
and deliver tailored breast-feeding educational messages in varied multimedia formats using a combination of 
text, images, and animations to account for the literacy levels of the subjects. Appropriate feedback will be given 
in the form of reinforced educational messages and encouragement and motivational prompts for those using 
the computer based program. Educational session in both the groups will last for 30 minutes. The first educational 
session will be performed during the post partum period, one day before the discharge from the hospital followed 
by week 6, months 3 and 6. Specific individualized interventions, especially during the initial critical 2-6 week 
period, are needed to prevent deterioration in intention levels for breast-feeding for 6 months and breast-feeding 
self-efficacy levels within the first 2 weeks postpartum which could lead to the decision to discontinue breast- 
feeding31. Subjects in both the groups will be given telephone reminders for follow up educational sessions. The 
touch screen computer based Breast-feeding Educational Support program will be placed on a mobile cart in the 
outpatient clinic of the RWMC, Scottsbluff. A research assistant will be available to guide the subjects in both the 
intervention (during the use of the tablet pc program) and the control groups (printed educational material) if 
needed. The breast-feeding educational modules and data collection instruments will be both in English and 
Spanish. 
 
 
 
 
 
 
 
 
 
 
Exclusion Criteria 
 
• 
Mental & physical challenge 
• 
Unavailability on telephone for follow up 
• 
Included in other Clinical trial on breast- 
feeding 
• 
Not willing to participate 
• 
Mothers who are admitted to ICU during 
 
 
 
Inclusion Criteria 
 
• 
Hispanic females 15 years and above 
• 
Agreeing to participate in the study 
• 
Process Variables 
Knowledge/attitudes/beliefs 
Perceived norms 
Breast-feeding self-efficacy 
Intent to breastfeed for 6 months 
Study Subject enrollment 

 
 
 
 
 
Randomization at RWMC, Scottsbluff Into two groups 
 
 
 
Educational Sessions in the intervention and attention groups. The educational session will be about 30 
minutes 
Post partum (at the time of discharge from 
the hospital) 
Week 6 
Month 3 
Month 6 
Figure5. Flow chart and education sessions in intervention and attention control groups 
 
Description of the variables 
The relevant study variables include (i) independent variables, (ii) process variables, (iii) potential confounding 
variables and (iv) dependent variables (outcomes). All the data gathering instruments will be available both in 
English and Spanish. 
a. Independent variables 
The study will have two groups: intervention group will receive bilingual Computer based Breast-feeding 
Educational Support program while attention control group will receive bilingual printed breast-feeding 
educational materials 
 
b. Process variables 
 
Variables impacting breast-feeding duration include; 
 
Breast-feeding Knowledge: The Breast-feeding Questionnaire (BKQ)24 was used in a randomized clinical trial 
of education and support for adolescent mothers24. Items from two tests of breast-feeding knowledge55, 56, were 
combined to provide a 30-item measure. Nineteen items developed for use with adolescent girls as a measure 
of laypersons’ breast-feeding knowledge55, were used in combination with 11 items from the Breast-feeding 
Knowledge Questionnaire (BKQ) 56. The questionnaire includes multiple-choice and true-false items on the 
components of breast milk, colostrums, weaning and breast-feeding techniques. Reliability (internal consistency 
alpha coefficient-KR20) of the measure was .70 (Appendix B). 
 
Breast-feeding Attitude/Beliefs: The Breast-feeding Attrition Prediction Scale (short-form) [BAPT] Spanish and 
English38, 39. This 35 item scale is based on theory of planned behavior57. It includes 4 sub-scales:1) positive 
breast-feeding sentiment (PBS); 2) negative breast-feeding sentiment (NBS); 3) social support and professional 
support (SPS) and 4) perceived behavioral control (PBC) for breast-feeding. Two International Board Certified 
lactation consultants reviewed the revised BAPT and judged the items to be both relevant and appropriate. 
Reliability was good with sub-scales scoring .67-.88 Cronbach’s alpha. The overall scale demonstrated predictive 
validity by differentiating sustained breast-feeding at 8 weeks 38 (Appendix C) 
 
Perceived norms: Is described as the perceived pressure to perform a behavior34. Social pressure will also be 
measured by a sub-scale of the revised BAPT. It is critical that perceived norms be measured for Hispanic 
Attention control (Printed Educational Materials) 
Intervention (Computer based Program) 

mothers since familism is an important cultural social structure in which the needs of the family as a group are 
more important than the needs of any individual family member and may include nutrition behaviors58. This strong 
cultural value in Mexican American families embodies social support within the extended family59, 60 (Appendix 
C) 
 
Breast-feeding Self-Efficacy: Self-efficacy is the personal belief that one can effectively perform a given 
behavior and that the behavior will result in the desired outcome. Self-efficacy has also been identified as a 
modifiable psychosocial variable in predicting behavior performance61, including sustained breast-feeding62. We 
will use Breast-feeding self-efficacy scale short form (BSES-SF). The BSES-SF is a 14-item 5-point Likert scale 
questionnaire that has response categories that range from 1 = not at all confident to 5 = always confident. An 
internal consistency alpha coefficient of .97 was obtained for the revised total scale. Predictive validity was 
demonstrated by significantly higher breast-feeding self-efficacy scores in breast-feeding mothers compared to 
bottle-feeding mothers at 4 (p < .001) and 8 (p < .001) weeks postpartum. Content validity of 86% was established 
with a review by an expert panel62 (Appendix D) 
 
Intent to breastfeed for 6 months: -is defined as readiness to engage in a behavior. It will be measured by an 
intention question related to the mother’s perceived intent to breastfeed for the recommended 6 months. The 
question has been developed based on Fishbein & Ajzen’s guidelines34 and is “How likely is that you intend to 
breastfeed for 6 months is measured by a 7 point Likert scale (extremely likely to extremely unlikely)?” 
 
c. Dependent Variables 
 
Primary outcome: Primary outcome is partial (combined formula and breast milk feeding) or exclusive breast- 
feeding at six months63 and will be assessed using breast-feeding assessment questionnaire64 (Appendix E). The 
questionnaire will also assess information about the timing of introducing solid food during the first six months. 
Exploratory analysis will also be performed to determine the proportion of Hispanic rural women who continue 
to do exclusive breast-feeding at six months in both the intervention (bilingual computer based breast- feeding 
educational support program) and control (bilingual printed breast-feeding educational materials) 
 
Acceptance of Computer-based Breast-feeding Educational Support program: We will adapt and use previously 
published questionnaire used to assess acceptance of computer based asthma educational program46 (Appendix 
F). Feedback will be gathered on ease of use of program, navigation patterns, and feedback during the program, 
future use of program and recommendation to others to use the program. Usage data analysis will help to 
understand learning patterns during use of the computer program by gathering the amount of time an individual 
spent on viewing the educational modules. 
d. Potential Confounders 
Socio-demographics: Include age, income levels, employment status, and education level, smoking status, prior 
pregnancies and previous history of breast-feeding. Information is also gathered about prior use of computers, 
its frequency of usage prior use of internet and sources of health information (Appendix G). Health literacy is the 
ability to perform basic reading and numerical tasks required to function in the health care environment65. Studies 
have shown an association between limited health literacy and worse health outcomes such as poorer knowledge 
about health conditions66, 67. The 3 health literacy screening questions, which performed optimally in a previous 
study68, will be used to assess health literacy assessments of Hispanic rural women (Appendix H) and include: 
“How often do you have someone (like a family member, friend, hospital/clinic worker or caregiver) help you read 
hospital materials?” (Help Read), “How often do you have problems learning about your medical condition 
because of difficulty understanding written information?” (Problems Reading), and “How confident are you filling 
out forms by yourself?” (Confident with forms). Responses will be scored on a Likert scale from 0 to 4 and were 
asked to choose between all of the time, most of the time, some of the time, a little of the time or none of the 
time68. 
 
In addition, Newest Vital Sign (NVS) consisting of a nutrition label with 6 accompanying questions to assess 
literacy will be used69. It takes approximately 3 minutes to administer, and is meant to allow healthcare providers 
to make a quick assessment of patients’ literacy, which can then allow them to adapt communication to achieve 
better outcomes. It assesses literacy and numeracy, and is available in both English and Spanish versions. The 

NVS has good reliability and validity for both English (Cronbach’s alpha=0.76) and Spanish versions (Cronbach’s 
alpha=0.69)69 (Appendix I) 
 
Subject recruitment 
 
We will recruit subjects for focus groups, usability studies and the final evaluation from antenatal clinic at RWMC, 
Scottsbluff. The study information will be provided to the prospective subjects by the physicians and the other 
staff at the RWMC, Scottsbluff. Information about the study will also be disseminated through information flyers. 
The research staff at the College of Public Health (COPH) and College of Nursing (CON) Scottsbluff will gather 
data during the study months (Appendix J). 
Subject eligibility 
 
The inclusion criteria include; (1) Hispanic females age 15 years and above, (2) agreeing to participate in the 
study (3) telephone contact and (4) available for follow-up interview. The rationale for including 15 year old teen 
mothers is because Scottsbluff County has highest teen pregnancy rate in the State of Nebraska70-72. We will 
include only mothers in the proposed study as the focus of the study is to analyze her attitudes, beliefs, her 
perceived norms towards breast-feeding; breast-feeding self-efficacy and intend to breast-feed her baby for 6 
months. Subjects will be excluded if any of the following criteria are met including; (1) mental and physical 
challenge that makes it difficult to use the touch based computer program, (2) unavailability for telephone follow- 
up and (3) involvement in other clinical trials or protocols related to breast-feeding, (4) Mothers who are admitted 
to ICU during their hospital stay, (5) Birth weight of <2500 gms, (6) <36 weeks gestation, (7) a bilirubin >15 mg%, 
(8) NICU admission to provide a sample of stable infants and (9) still birth. 
Data Collection procedures 
 
Baseline data will be gathered during the enrollment prenatal visit (anytime during last six weeks of pregnancy) 
and follow up data will be collected on postpartum day 3, week 6 and months 3 and 6 resulting in overall five 
data collection time periods. The postpartum day 3 data collection will be done over the telephone while other 
follow up data collection including week6 and months 3 and 6 will be done when the individuals in both the groups 
will come to the hospital for follow up educational sessions. Almost all women who initiate breast-feeding plan to 
continue for at least 6 weeks; however, one of every five women quits breast-feeding within the first days after 
delivery73. This finding supports the notion that 2–4 weeks postpartum is a vulnerable period for breast- feeding 
cessation74. Baseline evaluation will be done during the prenatal visit (last trimester). The research assistant will 
schedule a follow up interview to administer the study questionnaires at a convenient time over the telephone. 
Subjects will receive gift vouchers worth $15 for baseline and for every follow up postpartum visit (Table2). 
 
 
 
Pre and Post educational Session data 
collection 
Baseline 
Day 3 
Week 6 Month 3 
Month 6 
Socio-demographics 
X 
Health Literacy 
X 
Breast-feeding Knowledge 
X 
X 
X 
X 
X 
Breast-feeding self-efficacy 
X 
X 
X 
X 
X 
Intent to Breast-feed 
X 
X 
X 
X 
X 
Breast-feeding attitudes 
X 
X 
X 
X 
X 
Perceived norms 
X 
X 
X 
X 
X 
Program acceptance 
X 
X 

Table2. Data Collection in intervention and attention control groups 
 
Informed Consent 
Lupe Salazar (Consultant) is a bilingual and certified Spanish translator and will administer the informed consent 
and assent forms at the RWMC, Scottsbluff after the eligible subjects have agreed to participate in the study. 
The research staff members will read the UNMC IRB-approved consent and assent forms to subjects describing 
the study, the measures used by the researchers to protect the confidentiality of the responses, and the voluntary 
nature of the study. Those who agree to participate will be asked to sign the consent and the assent forms as 
appropriate. The research staff member will countersign the consent and the assent forms and copies will be 
given to the participant. 
 
Data Entry and Quality Assurance 
The research assistants will perform data entry and Dr. Meza (Co-Investigator) will be responsible for data 
management. Data will be entered into a relational database structure using Microsoft Access Forms and 
inconsistencies will be generated automatically by the system for verification with original forms. To ensure 
efficiency and high quality data collection and processing, we will have (1) well trained team of research 
assistants (2) clearly defined study manual (3) weekly meetings with the research staff, (4) logs of all patient 
contacts. To ensure efficient and accurate data management, we will (1) maintain logs of all the data instruments 
filled during each visit for every patient (2) central data processing and (3) weekly data checks. Minimal risks of 
anxiety related to filling out instruments and demographic forms may be experienced by the participants. Methods 
of recruitment consistent with ethical access will be used to identify patients who meet eligibility criteria and to 
invite them to participate in the study. All data collected with be kept confidential. Data files will be coded by 
number to retain the anonymity of the participants between focus groups. All data will be stored in a password 
protected computer in a locked office of the PI for 3 years from the point of the study completion at which time 
they will be destroyed. Security of the data will be maintained through regular backups, and all computers and 
specific data files will be password protected and kept in a locked file cabinet (Appendix K). 
 
VII. Analysis Plan 
The study will produce a very rich database consisting of a spectrum of outcome variables including the primary 
and secondary outcomes; it also contains information on many potential confounders and process variables. The 
overall objective is to investigate the impact of the intervention of using touch screen computer based breast- 
feeding educational support program compared to the traditional methods of informing the subjects regarding 
breast-feeding during their prenatal visit at the hospital. A detailed statistical analysis plan is outlined below. 
Focus Group Analysis 
Analysis will be systematic, sequential, verifiable, and continuous in order to minimize the potential bias 
introduced in analyzing and interpreting focus group data. The main source of data analysis will be the recorded 
spoken language. We will use Framework analysis approach as it provides a clear series of steps, which could 
help to manage the large amount and complex nature of qualitative data much more easily75. The other distinctive 
aspect of this analysis approach is that although it uses a thematic approach, it allows themes to develop both 
from the research questions and from the narratives of research participants75. The analytical process involves 
a number of distinct though highly interconnected stages including: familiarization; identifying a thematic 
framework; indexing; charting; mapping and interpretation75. 
We will conduct this analysis on the audio recorded data and the observational notes gathered during the focus 
group interviews. The aim will be to immerse in the details and get a sense of the interview as a whole before 
breaking it into parts. Themes will emerge lifting the quotes from the original context and re-arranging them under 
the newly-developed appropriate thematic content. One of the most important aspects of this task is data 
reduction, which is achieved by comparing and contrasting data and cutting and pasting similar quotes together. 
The data are now ready for the final stage of analysis, i.e. mapping and interpreting and prior studies have 
suggested the following headings as a framework for interpreting coded data: words; context; internal 
consistency; frequency and extensiveness of comments; specificity of comments; intensity of comments; big 
ideas. Computer-based approach will be employed for cutting, pasting, sorting, arranging and rearranging data 
through comparing and contrasting the relevant information using specialized software such as nVIVO 76. 

Exploratory Data Analysis 
 
In the first step of exploratory analysis, we will present a table to summarize the distribution of all variables, 
including outcomes, confounding, and process variables. This table will also serve the purpose of quality control 
of the original data, to mine missing data patterns and outliers. The distributions of the continuous outcomes will 
be explored for normality and transformations will be used if warranted. Continuous variables will be summarized 
using means, medians, standard deviations and ranges while categorical variables will be examined using 
frequencies and percentages. Exploratory analysis on process variables will be used for post-hoc analysis. Inter- 
rater reliability of knowledge, attitudes/beliefs, self-efficacy and intent to breast feed will be examined using the 
kappa statistic. 
Sample Size Justification 
The optimum number of participants for a focus group is typically 6-10 people with similar backgrounds who 
participate in the interview for one to two hours may vary52. The number generally suggested as being 
manageable is between six and ten participants as smaller groups show greater potential and large enough to 
gain a variety of perspectives and small enough not to become disorderly or fragmented52. For the intervention 
effect analysis, a comparison of two independent binomial proportions using Pearson’s Chi-square statistic with 
a two-sided significance level of 0.05, a sample size of 23 per group achieves a power of at least 0.8 when the 
proportion with partial breast-feeding at 6 months are 0.3 for the control group and 0.7 for the intervention group. 
To account for anticipated attrition of 15%, the sample size will be increased to 54 subjects (27 per group). This 
is a pilot study to explore the possibility of promoting breast-feeding using computer based breast-feeding tailored 
educational program among Hispanic rural women. 
Statistical Analysis 
Baseline characteristics will be summarized by intervention group. A chi-square test will be used to compare baseline 
categorical variables between the intervention and control groups and a t-test will be used for continuous variables. 
The primary outcome of proportion partial or exclusive breast-feeding at 6 months will be compared between groups 
using a Chi-square test. The primary outcome will be assessed at 6 months; however, we will also conduct these 
analyses at 6 weeks and 3 months. A generalized linear mixed model using a binomial distribution and logit link 
function will be used to examine partial breast-feeding at day 3, week 6 and months 3 and 6 postpartum, with 
intervention group as a fixed effect and subject as a random effect using a Variance Components covariance 
structure. In exploratory analyses, covariates will be added to the model to adjust for confounders that differ 
significantly between both the intervention and attention control groups at the 0.20 level of significance. Similar 
analyses will be conducted to examine exclusive breast-feeding. Breast-feeding knowledge, self-efficacy, will be 
compared between groups using a t-test. In exploratory analyses, a general linear mixed model with intervention  
group as a fixed effect and subject as a random effect using an AR (1) covariance structure will be examined. 
Covariates will be added to the model to adjust for confounders that differ significantly between both the intervention 
and attention control groups at the 0.20 level of significance (Table3). 
 
Variables 
Assessment 
Variable types 
Data Analysis 
Anticipated Outcomes 
Focus groups 
Qualitative 
Framework analysis 
Breast-feeding 
educational 
modules and functionality of the 
computer 
based 
program 
established 
Socio-Demographics 
Continuous & 
Categorical 
T test for continuous and 
Chi-square 
tests 
for 
categorical variables. 
Distribution 
of 
population 
characteristics 
Intent to Breast-feed 
Categorical 
Chi-Square test 
Assess intent to breast-feed 

Breast-feeding 
knowledge 
Continuous 
T test 
Improve Breast-feeding knowledge 
(intervention) 
Breast-feeding attitudes 
and beliefs 
Continuous and 
categorical 
T test for continuous and 
Chi-square 
tests 
for 
categorical variables. 
Change 
Breast-feeding 
related 
attitudes and beliefs 
Breast-feeding 
perceived norms 
Continuous and 
categorical 
T test for continuous and 
Chi-square 
tests 
for 
categorical variables. 
Change 
Breast-feeding 
related 
behavior 
Breast-feeding 
self- 
efficacy 
Continuous 
T test 
Improve self-efficacy (intervention) 
Breast-feeding 
assessment 
Categorical 
Chi-square test 
Better 
breast-feeding 
practices 
(intervention) 
Table3. Analysis Plan 
VII. Project Timelines and Milestones 
The research plan entails the performance of the following tasks: (a) Modify and enhance the PEMT to deliver 
breast-feeding education to the Hispanic rural women about major topics such as: review the benefits of breast- 
feeding, principles of lactation, myths, common problems, solutions and skills training appear to have the greatest 
effect, (b) deliver education tailored to individual profiles including demographics age and health literacy, 
(c) Other variable information gathered will include breast-feeding knowledge, attitudes and practices, (d) 
implement tailoring strategies, (e) assess the impact on the study outcomes and (f) perform data analysis and 
report the results. The Research investigators will coordinate a meeting once every month. The meeting points 
will be mailed to the members of the research team 72 hours before the meeting so that enough time is available 
to review and provide appropriate suggestions as needed. The research analysts will be responsible for the 
overall coordination of the meetings. The timeline of the study has been presented in the Table below (Table4). 
 
Tasks involved 
Timeline 
Objectives 
Research Team meet 
Month 1 
To formulate and strategize the study implementation 
plan 
Focus group and Analysis 
Months 2&3 
Identify relevant breast-feeding educational modules 
Breast-feeding 
Educational 
Content developed (English 
and Spanish) 
Months 3-5 
Develop breast-feeding educational modules based on 
initial findings of the focus group and investigators’ expert 
opinion. 
Modify existing PEMT 
Months 5-6 
Modify and integrate the breast-feeding educational 
modules into a computer format 
Computer program redesign 
using heuristic principles 
Months 5-6 
Modify and integrate the breast-feeding educational 
modules into a computer format 
User testing 
Months 6 
Usability evaluation of the system 
System deployment 
Months 7 
System modified based on users feedback and final 
deployment of the computer program 
Subject Recruitment 
Months 8 to 13 
Subject Enrollment initiated 

Data Collection 
Months 8-20 
Baseline and follow up data collection 
Analysis and Results 
Month 6, 12, 20 
Data entry, data analysis and initial findings reported 
Dissemination 
Month 6, 12, 18, 
24 
Final study findings disseminated to the funding and other 
key agencies 
Table4. Project Timeline