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Behavioral Intervention
Mobile App for Breastfeeding Support (KULEA-NET Trial)
Phase 2
Waitlist Available
Led By Loral Patchen, PhD
Research Sponsored by Benten Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Awards & highlights
KULEA-NET Trial Summary
This trial will test an mHealth app to improve exclusive breastfeeding among African American/Black mothers, potentially resulting in better maternal and infant health outcomes.
Who is the study for?
This trial is for African American/Black mothers aged 18-44 who plan to continue breastfeeding after hospital discharge, speak English, own a smartphone with internet access, and consent to participate. It excludes those with HIV, active tuberculosis or hepatitis B/C, certain viral infections, recent breast surgery or radiation therapy; mothers using drugs incompatible with lactation or whose infants have specific health conditions.Check my eligibility
What is being tested?
The KULEA-NET study tests a mobile app designed to boost knowledge and confidence in exclusive breastfeeding among African American/Black mothers. The control group receives usual care while the test group uses the KULEA-NET app aiming for better breastfeeding outcomes.See study design
What are the potential side effects?
Since this intervention involves the use of a mobile application rather than medication, there are no direct medical side effects. However, users may experience increased screen time which could affect sleep patterns or cause eye strain.
KULEA-NET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change of exclusive breastfeeding (EBF) rates
Secondary outcome measures
Change of any breastfeeding (BF) rates
Change of breastfeeding initiation rates
Other outcome measures
Change of breastfeeding attitudes
Change of breastfeeding self-efficacy
Change of intention to breastfeed
+4 moreKULEA-NET Trial Design
2Treatment groups
Experimental Treatment
Group I: KULEA-NET applicationExperimental Treatment1 Intervention
Participants using the KULEA-NET application in addition to the usual care
Group II: Control Group: Usual CareExperimental Treatment1 Intervention
Control participants will receive usual care i.e. standard obstetrical care at MWHC and Mamatoto Village and will receive the standard Babyscripts app only without the KULEA-NET tile.
Find a Location
Who is running the clinical trial?
Medstar Health Research InstituteOTHER
189 Previous Clinical Trials
115,050 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
380 Previous Clinical Trials
1,215,131 Total Patients Enrolled
Benten Technologies, Inc.Lead Sponsor
2 Previous Clinical Trials
181 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing radiation therapy.I do not have T-Cell lymphotropic virus type I or II.My newborn has a condition like cleft lip/palate or Down Syndrome that needed NICU care.I have active tuberculosis that has not been treated.I am currently on antiretroviral or chemotherapy medication.I have had breast surgery.I am between 18 and 44 years old.I am taking medication that is not safe for breastfeeding.I am HIV positive.I have been exposed to anthrax.I have active hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: KULEA-NET application
- Group 2: Control Group: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must potential participants fulfill to be eligible for this research?
"This clinical trial is aimed at mothers who are breastfeeding and between ages 18-44. The study seeks to enroll a total of 523 individuals."
Answered by AI
Has the KULEA-NET application been given authorization from the FDA?
"After careful consideration, our team at Power graded KULEA-NET a 2 on the safety index. This is due to Phase 2 trial data suggesting basic safeguards have been established but no evidence of efficacy being demonstrated yet."
Answered by AI
Does this research trial accept applicants aged eighteen years or older?
"The age bracket for potential participants of this medical trial stands at 18 to 44 years old. Separately, there are 24 trials tailored to minors and 32 designed specifically for elderly patients."
Answered by AI
Are there any openings currently available for prospective participants in this experiment?
"According to clinicaltrials.gov, this medical study is not presently recruiting participants; the first post was made on November 1st 2023 and it has been updated for the last time on August 3rd of that same year. However, there are currently 67 other trials actively searching for subjects."
Answered by AI
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