Pregnancy RelatedNCT03308058
Feasibility of a Touch Screen Computer Based Breast-feeding Educational Support Program
A study testing Breastfeeding computer education in people with Pregnancy Related, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Breastfeeding computer education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2012to 5 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Regional West Medical Center
Scottsbluff, Nebraska, 69361
About this study
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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Breastfeeding computer education
- Keywords
- Breastfeeding Rural Hispanic Pregnant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding computer educationBehavioural
Breastfeeding computer education
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding Computer education | Experimental | Breastfeeding Computer education Receives: Behavioral: Breastfeeding computer education |
| Printed Educational material | No intervention | Printed educational material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Assessment
Questionnaire Breastfeeding duration (Specify time) __________
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start18 Oct 2012
- Primary completion5 Jan 2018
- Study completion5 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Wilhelm, PhD, Study chair, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308058
- Sponsor's protocol ID
- 0430-12-EP
- Status last verified
- Sep 2023
- First submitted
- 30 Oct 2012
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22735734Thompson 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.
PubMed 22682718Joshi 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.
PubMed 20007653Joshi 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.
PubMed 19897458Joshi 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.
PubMed 18057566
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Touch Screen Computer Based Breast-feeding Educational Support Program
- ClinicalTrials.gov ID
- NCT03308058
- Acronym / sponsor ID
- 0430-12-EP
- Conditions
- Pregnancy Related
- Keywords
- Breastfeeding Rural Hispanic Pregnant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 18 Oct 2012 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Computer education | Experimental | Behavioral: Breastfeeding computer educationBreastfeeding Computer education |
| Printed Educational material | No intervention | –Printed educational material |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Hispanic females age 15 years and above
- Pregnant
- Agreeing to participate in the study
- Understand spoken English
- Telephone at home
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding computer educationBreastfeeding computer education | Behavioural | Breastfeeding Computer education |
Primary outcome
Breastfeeding Assessment
Time frame: 0-6 months
Questionnaire Breastfeeding duration (Specify time) __________
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22735734Thompson 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.
- Background: PubMed 22682718Thompson 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.
- Background: PubMed 20007653Joshi 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.
- Background: PubMed 19897458Joshi 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.
- Background: PubMed 18057566Joshi 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.
Related trials for Pregnancy Related
RecruitingPhase 2
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Cervical Cancer, Throat Cancer
RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 1/2
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma
Recruiting
PTSD Screening in Pregnant Black Women
Pregnancy Early, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Wilhelm, PhD study chair
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding computer education in people with Pregnancy Related, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Assessment (time frame: 0-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308058, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.