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

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ClinicalTrials.gov Identifier: NCT03036696
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pediatric Obesity Recruitment 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.

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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Breastfeeding and Early Child Health (BEACH) Interview Study
Actual Study Start Date : September 7, 2017
Actual Primary Completion Date : August 9, 2019
Actual Study Completion Date : August 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA) [ Time Frame: 1 year ]
  2. Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR) [ Time Frame: 1 year ]
  3. Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS) [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Non-invasive biospecimens include stool, saliva, blood, urine, human milk, and vaginal swab.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036696


Locations
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United States, Florida
Magda Francois
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Dominick J Lemas, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03036696     History of Changes
Other Study ID Numbers: IRB201601909
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Retention
Lactation
Human milk
Pregnancy
Clinical Research Studies
BEACH

Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms