NCT03308058

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2012

Completed
5 years until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 19, 2019

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

5.2 years

First QC Date

October 30, 2012

Results QC Date

January 30, 2018

Last Update Submit

September 21, 2023

Conditions

Keywords

Breastfeeding Rural Hispanic Pregnant

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Assessment

    Questionnaire Breastfeeding duration (Specify time) \_\_\_\_\_\_\_\_\_\_

    0-6 months

Study Arms (2)

Breastfeeding Computer education

EXPERIMENTAL

Breastfeeding Computer education

Behavioral: Breastfeeding computer education

Printed Educational material

NO INTERVENTION

Printed educational material

Interventions

Breastfeeding computer education

Breastfeeding Computer education

Eligibility Criteria

Age15 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, Regional West Medical Center

Scottsbluff, Nebraska, 69361, United States

Location

Related Publications (5)

  • Thompson DA, Joshi A, Hernandez RG, Jennings JM, Arora M, Ellen JM. Interactive nutrition education via a touchscreen: is this technology well received by low-income Spanish-speaking parents? Technol Health Care. 2012;20(3):195-203. doi: 10.3233/THC-2012-0669.

    PMID: 22735734BACKGROUND
  • Thompson DA, Joshi A, Hernandez RG, Bair-Merritt MH, Arora M, Luna R, Ellen JM. Nutrition education via a touchscreen: a randomized controlled trial in Latino immigrant parents of infants and toddlers. Acad Pediatr. 2012 Sep-Oct;12(5):412-9. doi: 10.1016/j.acap.2012.03.020. Epub 2012 Jun 7.

    PMID: 22682718BACKGROUND
  • Joshi A, Weng W, Lichenstein R, Arora M, Sears A. Prospective tracking of a pediatric emergency department e-kiosk to deliver asthma education. Health Informatics J. 2009 Dec;15(4):282-95. doi: 10.1177/1460458209345899.

    PMID: 20007653BACKGROUND
  • Joshi A, Arora M, Dai L, Price K, Vizer L, Sears A. Usability of a patient education and motivation tool using heuristic evaluation. J Med Internet Res. 2009 Nov 6;11(4):e47. doi: 10.2196/jmir.1244.

    PMID: 19897458BACKGROUND
  • Joshi A, Lichenstein R, Rafei K, Bakar A, Arora M. A pilot study to evaluate self initiated computer patient education in children with acute asthma in pediatric emergency department. Technol Health Care. 2007;15(6):433-44.

    PMID: 18057566BACKGROUND

Results Point of Contact

Title
Jane Meza
Organization
University of Nebraska Medical Center

Study Officials

  • Susan Wilhelm, PhD

    University of Nebraska

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2012

First Posted

October 12, 2017

Study Start

October 18, 2012

Primary Completion

January 5, 2018

Study Completion

January 5, 2018

Last Updated

September 28, 2023

Results First Posted

June 19, 2019

Record last verified: 2023-09

Locations