- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02701868
Unintentional Overfeeding of Formula Fed Infants (Whoa Baby)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70808-4124
- Pennington Biomedical Research Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Phase 1 will utilize qualitative data gathered from focus groups to direct the modification of infant formula manufacturer preparation instructions to enhance user understanding and accuracy. The modified instructions will be used in Phase 2.
Up to 150 individuals will be enrolled in Phase 2 to test the efficacy of the revised instructions on infant overfeeding in comparison with the instructions currently provided on the packaging.
Beskrivelse
Inclusion Criteria:
- ≥18 years of age
- Willing to participate in 1 assessment visit at Pennington Biomedical Research Center
- English speaking
Exclusion Criteria:
- <18 years of age
- Not willing to participate in 1 assessment visit at Pennington Biomedical Research Center
- Non-English speaking
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Phase 1
Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center.
Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Demonstration Kitchen over the course of approximately 3 months.
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Phase 2
Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited to test the efficacy of the revised instructions on infant overfeeding in comparison with the instructions currently provided on the packaging.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Focus Group Recommendations to Improve Infant Formula Preparation Instructions
Tidsramme: Day 1
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Focus groups were used to evaluate and provide recommendations to improve the reading and comprehension of powdered infant formula package preparation instructions.
Five focus groups provided primary recommendations.
The percentage of focus group participants reporting specific recommendations are summarized.
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Day 1
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Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight
Tidsramme: Day 1
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Percent Error of the formula weight prepared by Phase 2 study participants as compared to the expected formula weight from the manufacturer's label. Phase 2 participants were either randomly assigned the standard instructions or the instructions that were modified as a result of the Phase 1 focus groups. Percent error was calculated as the measured formula weight prepared by Phase 2 study participants subtracted from the expected formula weight found on the manufacturer's label with that result being divided by the expected formula weight found on the manufacturer's label. The final result is multiplied by 100 to provide the percent error. Percent error is presented as opposed to formula weight because each participant prepared two 2, 4, 6, and 8 oz bottles. Percent error analysis includes all bottles prepared regardless of size. |
Day 1
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Anne Gilmore, Ph.D., Pennington Biomedical Research Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PBRC2016-002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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