The BEACH Interview Study- Pregnant and Breastfeeding Mothers

Pediatric Obesity Clinical Trial

— BEACH  

Official title:

The Breastfeeding and Early Child Health (BEACH) Interview Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036696
• Other study ID #: IRB201601909
• Status: Completed
• Start date: September 7, 2017
• Est. completion date: August 9, 2019

Study information

• Verified date: August 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 9, 2019
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pediatric Obesity
• Recruitment

Intervention

Other:
• Pregnant Mothers Interview
Pregnant 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.
• Breastfeeding Mothers Interview
Breastfeeding 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.

Locations

Country	Name	City	State
United States	Magda Francois	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strategies for recruiting and retaining pregnant and breastfeeding mothers into clinical research studies (CRTs) will be measured by way of interview.	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.	6 months
Secondary	Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)		1 year
Secondary	Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR)		1 year
Secondary	Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS)		1 year