The BEACH Interview Study- Pregnant and Breastfeeding Mothers

Completed

• Conditions: Pediatric Obesity; Recruitment
• Interventions: Other: Pregnant Mothers Interview; Other: Breastfeeding Mothers Interview

• Registration Number: NCT03036696
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-30
• Study Start: 2017-09-07
• Status Verified: 2019-08
• Primary Completion: 2019-08-09
• Study Completion: 2019-08-09
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

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

Read More

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).

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Mothers Interview	Pregnant Mothers Interview	(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.
Breastfeeding Mothers Interview	Breastfeeding Mothers Interview	(1) 18 years old or over, (2) actively breastfeeding infant less than 12 months of age, and (3) lives in Gainesville, Florida.

Primary Outcome Measures

Name	Time	Method
Strategies for recruiting and retaining pregnant and breastfeeding mothers into clinical research studies (CRTs) will be measured by way of interview.	6 months	Interviews will be analyzed to determine the efficacy of common strategies used to recruit pregnant and breastfeeding mothers into CRTs, challenges or barriers that would preclude women from enrolling and participating in CRTs, their preferences for incentives, as well their preference and methods related to non-invasive sample collection.

Secondary Outcome Measures

Name	Time	Method
Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR)	1 year
Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS)	1 year
Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)	1 year

Trial Locations

Locations (1)

Magda Francois; 🇺🇸 Gainesville, Florida, United States