An observational study in Pediatric Obesity and Recruitment, sponsored by University of Florida. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-12.
Sponsored by University of Florida · Observational
Interview pregnant and breastfeeding mothers in the Gainesville, FL area to optimize; clinical study recruitment and retention, patient-centered outcomes, and stool collection procedures.
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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 59 is below the median of 200 across 231 observational studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
(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
(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
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 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.
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.
Time frame: 6 months
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
Plan to share: Yes — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University of Florida