The BEACH Interview Study- Pregnant and Breastfeeding Mothers

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Breastfeeding and Early Child Health (BEACH) Interview Study

Conditions
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Pediatric Obesity, Recruitment

Intervention / Treatment
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* Other: Pregnant Mothers Interview
* Other: Breastfeeding Mothers Interview


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Mothers Interview<br>(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<br>* 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.<br>|
| Breastfeeding Mothers Interview<br>(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<br>* 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.<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BEACH, Retention, Lactation, Human milk, Pregnancy, Clinical Research Studies