The BEACH Interview Study- Pregnant and Breastfeeding Mothers (BEACH)

The Breastfeeding and Early Child Health (BEACH) Interview Study

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

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity; Recruitment
• Intervention / Treatment: Other: Pregnant Mothers Interview; Other: Breastfeeding Mothers Interview

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 Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Magda Francois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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; (1) 18 years old or over, (2) actively breastfeeding infant less than 12 months of age, and (3) lives in Gainesville, Florida.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)	1 year
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

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2017
• Primary Completion (Actual): August 9, 2019
• Study Completion (Actual): August 9, 2019

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Pregnancy; Retention; Lactation; Human milk; BEACH; Clinical Research Studies
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: IRB201601909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with the NIH Data Sharing Policy of award 1U24DK097193, all data generated by Southeast Center for Integrated Metabolomics (SECIM), along with the corresponding metadata, will be deposited into the NIH Metabolomics Data Repository and Coordinating Center (DRCC) as soon as all quality control steps are completed. Data will be embargoed for one year and, after the expiration of the embargo, made visible to the scientific community regardless of publication status for the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No