Breastfeeding Clinical Trial
— KULEA-NETOfficial title:
Knowledge and Usage of Lactation Using Education and Advice From Support Network (KULEA-NET)
Verified date | August 2023 |
Source | Benten Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
KULEA-NET is a mHealth intervention that will improve knowledge, self-efficacy, and intentions related to exclusive breastfeeding (EBF). These factors have been demonstrated to have a positive influence on breastfeeding (BF) initiation and duration among African American/Black (AA/B) mothers. In the long term, KULEA-NET has great potential to achieve increased BF initiation and EBF rates among AA/B mothers and as a result, improved maternal and infant health outcomes.
Status | Enrolling by invitation |
Enrollment | 523 |
Est. completion date | May 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility | Inclusion Criteria: - African American/Black Ethnicity - Speak and understand English, - Between the ages of 18-44 years, - Intention to continue BF after discharge from the hospital - Willingly provide written informed consent - Own a smartphone (either iOS or Android) - Have access to the internet through their smartphone Exclusion Criteria: - An infant born with cleft lip/palate, congenital heart defects, Down Syndrome, neural tube defects, or other conditions that require admission to a NICU or interfere with BF - Human immunodeficiency virus (HIV) - Taking antiretroviral medication or chemotherapy agents - Untreated, active tuberculosis - T-Cell lymphotropic virus type I or type II - Illicit drug use - Receiving radiation therapy - Exposed to anthrax - Undergone breast surgery - Active hepatitis B or C - Any prescription drug use incompatible with lactation |
Country | Name | City | State |
---|---|---|---|
United States | Medstar Health Research Institute | Hyattsville | Maryland |
United States | Mamatoto Village | Washington | District of Columbia |
United States | The George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Benten Technologies, Inc. | George Washington University, Medstar Health Research Institute, National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change of breastfeeding attitudes | Iowa Infant Feeding Attitude Scale (IIFAS) | Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up | |
Other | Change of intention to breastfeed | Infant Feeding Intentions (IFI) Scale | Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up | |
Other | Change of breastfeeding self-efficacy | BF Self-Efficacy Scale Short Form (BSES-SF) | Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up | |
Other | Change of perceived social support and social self-efficacy | Interpersonal Support Evaluation List (ISEL) | Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up | |
Other | Usability | System Usability Scale (SUS)survey will be used to assess usability of the KULEA-NET app | Week 24 postpartum | |
Other | Engagement | Brand Equity Scale to measure engagement with the app | Week 24 postpartum | |
Other | Change of knowledge and beliefs about breastfeeding | Custom survey, based in part on an instrument developed by Dr. Evans and colleagues to evaluate the KULEA-NET intervention (GWU IRB approval # 111047), will be used to collect self-reported knowledge and attitudes related to breastfeeding. | Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up | |
Primary | Change of exclusive breastfeeding (EBF) rates | We will assess if participants are breastfeeding exclusively through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on EBF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #1. We will record information on EBF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #2. We will record information on EBF at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm #3. | Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up | |
Secondary | Change of any breastfeeding (BF) rates | We will assess if participants are breastfeeding through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on BF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #1. We will record information on BF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #2. We will record information on EBF at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm #3. | Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up | |
Secondary | Change of breastfeeding initiation rates | We will assess if participants are initiated breastfeeding through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on BF initiation at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm. | Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up |
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