Feasibility of a Touch Screen Computer Based Breast-feeding Educational Support Program
Condition: Pregnancy Related
Study type: Interventional

Summary: 
      Breastfeeding has many positive and long lasting impacts on the health of infants and
      mothers. The investigators propose to develop a bilingual touch screen computer based
      breastfeeding educational support program to promote breastfeeding among Hispanic rural women
      living in Scottsbluff area of rural Nebraska. An interactive, tailored, touch screen,
      bilingual breastfeeding educational program will be developed to deliver breastfeeding
      education to enhance partial or exclusive breastfeeding. An experimental two-group repeated
      measures design will be utilized. Ninety four prenatal Hispanic rural women aged 15 years and
      above will be enrolled and randomly assigned to either the intervention (computer based
      program, N=47) or attention control (printed educational material, N=47) groups at the
      Regional West Medical Center in Scottsbluff. Information gathered will include
      socio-demographics, familiarity with use of technology and health literacy assessment.
      Process variables measured will include breast-feeding knowledge and breast-feeding
      self-efficacy. Primary and secondary outcomes include breast-feeding duration in binary
      categories (partial or exclusive) and number of sick baby medical visits and months of
      illnesses. All assessments will be done at baseline, days 3 and 7, weeks 2 and 6 and months 3
      and 6 in both the intervention and attention intervention groups. The current proposed study
      may help advance our understanding to use health information technology as a medium to
      disseminate bilingual health education programs in rural 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
      breastfeeding among women across diverse settings.
    

Detailed description: 
      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. Dr. Aguirre and Ms. Salazar 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. The focus group interviews,
      analysis and development of breast-feeding educational modules in English and Spanish will be
      finalized during the first 5 months of the study. The focus group sessions will be audio
      recorded and stored in a locked cabinet. The sessions recordings will be destroyed at the end
      of the research study.

      Computer-based Breast-Feeding Educational Support Program: The investigators will modify
      existing touch screen, computer based interactive Patient Education and Motivation Tool
      (PEMT) 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:

      (i) PEMT modification design (ii) Tailoring (iii) Expert Pretesting using Heuristic
      evaluation (iv) Usability and User Testing

      Intervention and Evaluation:

      The subjects will be randomly enrolled using a 1:1 method with every other subject enrolled
      randomized to either the control or intervention group, at RWMC, Scottsbluff. Eligible
      individuals, who will meet the inclusion criteria, will be assigned into either intervention
      (bilingual Computer based Breast-feeding Educational Support program) or attention control
      (bilingual breast-feeding printed educational material) groups using a computer generated
      random id 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.

      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 and receive printed breast-feeding educational material.
      Using self-reported 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 postpartum 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-feeding. 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 for
      the duration of the study and will be collected after the completion of the research.

      There will be no repercussions to subjects since the touch screen computers will be placed at
      the RWMC and will be used by the subjects enrolled in the study at this site. A web based
      version will also be available for an ongoing support to subjects in the intervention group.
      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.
    

Intervention name(s): Breastfeeding computer education
Intervention type(s): Behavioral
Intervention description(s): Breastfeeding computer education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Breastfeeding Rural Hispanic Pregnant