- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00114582
Optimizing the Ambiance During Mealtimes in Dutch Nursing Homes
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Gelderland
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Wageningen, Gelderland, Olanda, 6700 EV
- Wageningen University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Prestazioni fisiche
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Qualità della vita
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Stato nutrizionale
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2420.0021
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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