Clinical Trials Directory

Trials / Completed

CompletedNCT03036696

The BEACH Interview Study- Pregnant and Breastfeeding Mothers

The Breastfeeding and Early Child Health (BEACH) Interview Study

Status
Completed
Phase
Study type
Observational
Enrollment
59 (actual)
Sponsor
University of Florida · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

Interview pregnant and breastfeeding mothers in the Gainesville, FL area to optimize; clinical study recruitment and retention, patient-centered outcomes, and stool collection procedures.

Detailed description

This is an interview study that will enroll mothers during 28 weeks or greater of pregnancy and assess recruitment, patient-centered outcomes, and stool collection procedures via individualized interviews and data collection. Participants will be recruited from the greater Gainesville, FL area. Data collection will include questionnaires/surveys as well as minimal risk non-invasive biological samples such as stool, human milk, saliva, vaginal swab, and urine collection. Participants will be seen at a location convenient for them.

Conditions

Interventions

TypeNameDescription
OTHERPregnant Mothers InterviewPregnant mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection and preferences for methods related to non-invasive sample collection. Data collection for pregnant mothers includes Clinical Health Update (3rd trimester) and Physical Activity questionnaires. The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab.
OTHERBreastfeeding Mothers InterviewBreastfeeding mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection, and preferences for methods related to non-invasive sample collection. Data collection for breastfeeding mothers includes Clinical Health update (post-natal), Infant Feeding, and Physical Activity questionnaires. The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab.

Timeline

Start date
2017-09-07
Primary completion
2019-08-09
Completion
2019-08-09
First posted
2017-01-30
Last updated
2019-08-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03036696. Inclusion in this directory is not an endorsement.