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The BEACH Interview Study- Pregnant and Breastfeeding Mothers

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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