The BEACH Interview Study- Pregnant and Breastfeeding Mothers

University of Florida

Status: Completed

Conditions: Recruitment; Pediatric Obesity

Treatments: Other: Breastfeeding Mothers Interview; Other: Pregnant Mothers Interview

Study type: Observational

Funder types: Other

Identifiers

NCT03036696

IRB201601909

Details and patient eligibility

About

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

Full 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.

Enrollment: 59 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

59 participants in 2 patient groups

Pregnant Mothers Interview

Description:

(1) 18 years old or over, (2) between 28-38 weeks of pregnancy, (3) lives in Gainesville, Florida, and (4) are committed to exclusively breastfeeding through 6 months.

Treatment:

Other: Pregnant Mothers Interview

Breastfeeding Mothers Interview

Description:

(1) 18 years old or over, (2) actively breastfeeding infant less than 12 months of age, and (3) lives in Gainesville, Florida.

Treatment:

Other: Breastfeeding Mothers Interview