- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02701868
Unintentional Overfeeding of Formula Fed Infants (Whoa Baby)
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Louisiana
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Baton Rouge, Louisiana, 미국, 70808-4124
- Pennington Biomedical Research Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Focus Group Recommendations to Improve Infant Formula Preparation Instructions
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Anne Gilmore, Ph.D., Pennington Biomedical Research Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .