Clinical trial NCT03036696: The BEACH Interview Study- Pregnant and Breastfeeding Mothers
Official title: The Breastfeeding and Early Child Health (BEACH) Interview Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Obesity
Recruitment
Keywords: Retention
Lactation
Human milk
Pregnancy
Clinical Research Studies
BEACH
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research team will recruit pregnant women (n = 30) and breastfeeding mothers' (n = 30) paired with infant (n=30) to participate in individual, in-depth, semi structured, and audio-recorded interviews.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Females 18\>45, between 28-38 weeks pregnant, lives in Gainesville, Florida, and committed to exclusively breastfeeding through 6 months.
* Females 18\>45, actively breastfeeding for \<12 months and lives in Gainesville, Florida

Exclusion Criteria:

* Mothers who do not plan to exclusively breastfeed their infant for at least the first 6 months or actively breastfeeding.
* Mothers who do not live in Gainesville, FL
* Mothers who are not between the ages of 18-45
* Mothers who are not between 28-38 weeks of gestation or a breastfeeding mother.
* Mothers who have only one breast which is capable of producing milk and/or have a history of inadequate milk production.
* Mothers who have consumed alcohol during this pregnancy.
* Mothers who have abused drugs during this pregnancy.
* Mothers who have smoked during this pregnancy.
* Mothers who have been diagnosed with pre-eclampsia during this pregnancy.
* Mothers who have had a previous pre-term delivery (baby born 2 months before the due date or \<35 weeks).

Primary outcomes:
measure: Strategies for recruiting and retaining pregnant and breastfeeding mothers into clinical research studies (CRTs) will be measured by way of interview.
timeFrame: 6 months
Secondary outcomes:
measure: Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)
timeFrame: 1 year
measure: Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR)
timeFrame: 1 year
measure: Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Magda Francois
state: Florida
Study officials:
affiliation: University of Florida
name: Dominick J Lemas, PhD
role: PRINCIPAL_INVESTIGATOR
References: