Unintentional Overfeeding of Formula Fed Infants (Whoa Baby)
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Louisiana
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Baton Rouge, Louisiana, Vereinigte Staaten, 70808-4124
- Pennington Biomedical Research Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Focus Group Recommendations to Improve Infant Formula Preparation Instructions
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Anne Gilmore, Ph.D., Pennington Biomedical Research Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PBRC2016-002
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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