- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00114582
Optimizing the Ambiance During Mealtimes in Dutch Nursing Homes
연구 개요
상세 설명
Study design: During six months the intervention group had their meals in family style, and the control group received the usual tray services.
Hypothesis: We hypothesized that the intervention program had a positive effect on quality of life, food intake, body weight, physical performance, and biochemical data (hematocrit, hemoglobin, leucocytes, ferretin, albumin, homocysteine and folate) among the residents in the intervention group, while these outcome measures would regularly decline among the residents in the control group.
Site and participants: Nursing homes volunteered to participate in the study. In each nursing home there was a control and intervention ward. Only residents with a chronic somatic disorder were included. Residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition. The ethical committee and the client board of the nursing homes and the medical ethical committee of Wageningen University approved the study protocol.
Intervention: The intervention program lasted for six months and was based on an inventory research of mealtime ambiance models in the Netherlands. The program consisted of five aspects: table dressing, food services, staff protocol, residents' protocol, and mealtime protocol. Before the start of the meal, tables were set with tablecloths, full cutlery and plates. The cooked meal was served in dishes and residents had the opportunity to choose between two kinds of vegetables, two kinds of meat and potatoes.
연구 유형
등록
단계
- 2 단계
연락처 및 위치
연구 장소
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Gelderland
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Wageningen, Gelderland, 네덜란드, 6700 EV
- Wageningen University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Nursing home residents with a chronic somatic disease and long term care
Exclusion Criteria:
- Residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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물리적 성능
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삶의 질
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영양 상태
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Mathey MF, Vanneste VG, de Graaf C, de Groot LC, van Staveren WA. Health effect of improved meal ambiance in a Dutch nursing home: a 1-year intervention study. Prev Med. 2001 May;32(5):416-23. doi: 10.1006/pmed.2001.0816.
- Nijs K, Vanneste V, de Graaf K, van Staveren W. [Project models to improve the ambiance during meal times in Dutch nursing homes: incentives and barriers for implementation]. Tijdschr Gerontol Geriatr. 2003 Dec;34(6):246-53. Dutch.
- Nijs KA, de Graaf C, Kok FJ, van Staveren WA. Effect of family style mealtimes on quality of life, physical performance, and body weight of nursing home residents: cluster randomised controlled trial. BMJ. 2006 May 20;332(7551):1180-4. doi: 10.1136/bmj.38825.401181.7C. Epub 2006 May 5.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .
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