---
title: The BEACH Interview Study- Pregnant and Breastfeeding Mothers
nct_id: NCT03036696
overall_status: COMPLETED
sponsor: University of Florida
study_type: OBSERVATIONAL
primary_condition: Pediatric Obesity
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03036696.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03036696"
ct_last_update_post_date: 2019-08-12
last_seen_at: "2026-05-12T06:14:02.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The BEACH Interview Study- Pregnant and Breastfeeding Mothers

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

**NCT ID:** [NCT03036696](https://clinicaltrials.gov/study/NCT03036696)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 59
- **Lead Sponsor:** University of Florida
- **Conditions:** Pediatric Obesity, Recruitment
- **Start Date:** 2017-09-07
- **Completion Date:** 2019-08-09
- **CT.gov Last Update:** 2019-08-12

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
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).
```

## Arms

- **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** — (1) 18 years old or over, (2) actively breastfeeding infant less than 12 months of age, and (3) lives in Gainesville, Florida.

## Interventions

- **Pregnant Mothers Interview** (OTHER) — 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** (OTHER) — 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.

## Primary Outcomes

- **Strategies for recruiting and retaining pregnant and breastfeeding mothers into clinical research studies (CRTs) will be measured by way of interview.** _(time frame: 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 Outcomes

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

## Locations (1)

- Magda Francois, Gainesville, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.magda francois|gainesville|florida|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03036696.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03036696*  
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