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Feasibility of a Touch Screen Computer Based Breast-feeding Educational Support Program

University of Nebraska logo

University of Nebraska

Status

Completed

Conditions

Pregnancy Related

Treatments

Behavioral: Breastfeeding computer education

Study type

Interventional

Funder types

Other

Identifiers

NCT03308058
0430-12-EP

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

Female

Ages

15 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Hispanic females age 15 years and above
  • Pregnant
  • Agreeing to participate in the study
  • Understand spoken English
  • Telephone at home
  • Available for follow-up interview.

Exclusion criteria

  • mental and physical challenge that makes it difficult to use the touch based computer program
  • unavailability for telephone follow-up and
  • involvement in other clinical trials or protocols related to breastfeeding.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

46 participants in 2 patient groups

Breastfeeding Computer education
Experimental group
Description:
Breastfeeding Computer education
Treatment:
Behavioral: Breastfeeding computer education
Printed Educational material
No Intervention group
Description:
Printed educational material

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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